HAI Europe Staff Blog

EU Policy Opportunities in Biomedical Innovation and the Public Good

2011-12-02T11:28:00.006+01:00

Together with the Trans Atlantic Consumer Dialogue (TACD), HAI Europe is currently finalising a policy paper on biomedical innovation for the European level. Sophie Bloemen and David Hammerstein are now making the last edits to the paper and it should be out soon. At our conference in the European Parliament: Horizon 2020: Investing in the Common Good on November 30, we took the opportunity to introduce the policy paper with an Executive Summary to all participants. Some key points of the Summary are covered below.

The current model of biomedical innovation tends to enclose knowledge using intellectual property (IP) rights that are meant to be rewarded in exchange for innovation. However, driven by today’s social and economic reality this model of innovation often fails to take into account economic sustainability, does not always deliver needs-oriented innovation, and tends to neglect the least wealthy parts of the world’s population including many European Union (EU) citizens. The Horizon 2020 EU Research and Innovation Framework provides the EU with an opportunity to make socially responsible choices that lead to new sustainable models of innovation which contribute to the common good.

In light of Horizon 2020 and the Innovation Union agenda, this Policy Brief offers an overview of the most important contemporary discussions, initiatives and proposals on biomedical innovation, and provides recommendations to European institutions on how to become leaders in exploring new and complementary models of innovation, establishing a truly innovative research agenda while implementing their commitments to Health Equity within the EU and to Global Health. Business as usual is no longer an option.

Various proposals and projects have been developed by governments, civil society, academics and industry which promote access and innovation. These include;

Socially responsible IP management or Equitable licensing

Open Source research

Voluntary licenses to the Medicines Patent Pool

Product Development Partnerships (PDPs)

Innovation inducement prizes

Intergovernmental Instrument on Coordinating & Financing of Biomedical R & D

The EU´s Horizon 2020 project should condition any release of knowledge property to a business plan that conforms to ethical, social and environmental objectives in accordance with the public interest. Furthermore, for the EU to be a leader in technological innovation, it needs to take a broader perspective and look at key developments in open source research and open medicine. The upcoming Horizon 2020 EU Research and Innovation Framework provides the EU with an opportunity to make socially responsible choices that lead to new sustainable models of innovation which contribute to the common good.

The full Executive Summary can be found here.

Statement on Medicines Patent Pool

2011-10-14T00:41:00.002+02:00

HAI Global and HAI Europe congratulate the Medicines Patent Pool (MPP) on the licensing agreement with generic companies, most notably Aurobindo. The sublicenses are a major step forward in the development of an effective MPP and will have a tangible impact on the lives of many patients and promise the prospect of real improvements in global Access to Medicines.

While acknowledging that these licences are an important step forward, with the potential to deliver real improvements in global Access to medicines, HAI also supports efforts for an inclusive and transparent dialogue with MPP, in order to ensure that persons living with HIV, the broader public health community and the MPP work together, and that everyone has an opportunity to be informed and consulted on core policy choices.

We have followed the discussion on the MPP Gilead licence and have been saddened at the discord to which it has led, both in and between the Access to Medicines network. There is no doubt that the opinions on the DPP differ; even within the HAI network we acknowledge disagreement on the MPP mechanism and its worth. We also recognize that there are outstanding issues and questions on the MPP and the Gilead licence, for example we are particularly disappointed the licence terms limit production to India.

Despite differences on specific substantive and process isuess, HAI has confidence in the competence and integrity of the MPP Staff and Board, and sees value in the MPP as one of several mechanisms to improve public health and bring greater transparency to the patent system. As part of international civil society, HAI will continue to campaign for strategies alongside the MPP, like supporting the use of TRIPS flexibilities and opposing TRIPS plus trade policies, addressing conditions and circumstance that cannot be addressed by the MPP. HAI will also continue to follow broader voluntary licence trends, such as opaque licensing negotiations between companies that exclude other stakeholders and we will campaign for alternative R&D models and incentives that de-link the cost of R&D from the price of the product. However, the MPP is an important contribution to contemporaneous access issues whilst we work towards perfect solutions.

There is a need for constructive dialogue between all stakeholders around the MPP issues in contention, without it frustrating or derailing the efforts of the MPP team in bringing us to this point. An informed and critical content discussion with MPP is important and should lead to improvement. What should be avoided is an accusative and aggressive tone which is unnecessary and not conducive to further fruitful cooperation on Access to Medicines. It will take time to have a clear view on the contributions and faults of the MPP, and critical voices from different regions will help the pool to develop. For now though, we are impressed by what the MPP staff has achieved and are anxious to see how it further develops.

Tim Reed HAI Global

Sophie Bloemen HAI Europe

Public Event on EU-MERCOSUR in Buenos Aires

2011-08-02T05:38:00.002+02:00

On Friday the 29th of July the first public event on the MERCOSUR-EU negotiations took place in the University of Buenos Aires, Argentina. Organized by the research institute CEIDIE, speakers included public officials from several ministries, academics such as Carlos Correa, Sandra Negro and Xavier Seuba, as well as representatives from the civil society (ABIA and HAI Europe).

Speakers discussed the background and the current state of the negotiations, as well as the prospective goals envisaged by the parties. Particular attention was devoted to agriculture and intellectual property. The event discussed the significant differences in approach and the difficulties to be overcome, with a view put on the public interest and development concerns.

Civil society presented its concerns with regards to public health and access to medicines and the possible role of the European Parliament in the negotiations.

With respect to intellectual property, fundamental differences between the parties were raised. Dr. Correa put the agreement in the context of the ever-increasing level of demands, while X. Seuba pointed out that in fact parties where not negotiating an IP chapter, but exchanging views on the role of intellectual property on economy and society.

The next round of negotiations will take place in November in Uruguay.

Sophie Bloemen

Study provides recommendations on European Medicines Agency's communication on medicines

2011-07-15T12:11:00.019+02:00

A recently published study produced by an independent expert offers recommendations to assist the European Medicines Agency's communication on the benefits and risks of medicines.

The report is a result of a year long project carried out by Dr Frederic Bouder and aims to provide evidence based input.

The study not only contains a detailed analysis of the expectations and attitudes of the different stakeholders of the agency regarding its communication on medicines but also draws up detailed recommendations for the agency such as the setting up of a risk communication advisory board.

The report further recommends the involvement of patients in communication activities, a review of the handling of its communication tools and to shape a strategic view on transparency.

The agency has already implemented some of the suggested recommendations.

Read the entire report here

The Diagnosis of Childhood Bipolar Disease has led to Catastrophic Consequences

2011-07-14T15:14:00.009+02:00

There has been a call for the diagnosis of childhood bipolar disease to be axed from the Diagnostic and Statistical Manual of Mental Disorders (DSM) by one of its early editors. Experts argue that Bipolar disease emerges in early adolescence, no sooner. Jon Ronson reports in this month’s edition of the New Scientist on the controversial condition.

The DSM offers a checklist of symptoms to help diagnose psychiatric illnesses. The ever-expanding index of the manual is said to be an attribute of society’s perception of what is normal behaviour; further influence stemming from the pharmaceutical industry and patients groups.

Mr. Frances Allen, former editor of the DSM, is now critical of aspects of the diagnostic tool, stating that the inclusion of Childhood Bipolar disease was a mistake. Tragically, in the United States, a four year old child died after receiving a fatal dose of her prescribed medication to treat the disease. Her parents administered the bipolar medication whenever the child was “being annoying”.

HAI Europe advocates the rational use of medicines and will be addressing issues relating to conflicts on interest and psychiatric medicines at an open-seminar: Mad Medicine: Are conflicts of interest driving you crazy? It will be held in Cork, Ireland, on the 24^th of September, 2011. Please contact Lorraine at events@haieurope.org for further information.

DG Trade State of Play reveals EU's ambitions for IP protection in FTAs

2011-07-12T16:31:00.006+02:00

The EU will not be changing its aggressive approach to IP protection in bilateral trade agreements, according to the updates that representatives from the European Commission gave at a State of Play meeting with civil society on June 27, 2011. Despite years of opposition and outrage by the global public health community, the EU continues to pursue high IP standards in trade deals with developing countries. Representatives from DG Trade stated that the EU will pursue ambitious IP standards in ongoing free trade agreement negotiations with India and Mercosur.

Apart from India and Mercosur, the EU is currently negotiating a trade deal with the Ukraine, where the need for medicines to treat such as HIV/AIDS is currently unmet. Aggressive IP protection introduced through the EU-Ukraine FTA could further restrict access to affordable ARVs, thwarting any initiative to slow the progression of this life threatening disease.

Evidence has shown that these ambitious IP provisions are detrimental to public health in countries with large poor populations because these policies have a negative impact on generic competition. Limited competition in the pharmaceutical market keeps prices high and hinders widespread access to medicines. In the Trading away access to medicines report (2009), HAI and Oxfam highlighted the problems of strict IP protection in the context of global health.

Even within the EU, an investigation into the EU pharmaceutical sector revealed a array of strategies used by companies to prolong the market dominance of their product, resulting in high prices for consumer and health care systems. (See HAI Europe response)

2011-06-30T13:04:00.005+02:00

TRIPS-Plus IP demands from EU could halt South American trade deal

13 June 2011

Negotiations for a trade agreement between the EU and South American trade bloc Mercosur are approaching yet another impasse, just a year after re-launching the talks.

Free trade negotiations between the EU and the Latin American trade bloc Mercosur (Argentina, Brazil, Paraguay and Uruguay) are stalled, in part because of demands from the EU that Mercosur introduce tougher measures to protect intellectual property rights.

In the light of Brazil becoming more self-sufficient in pharmaceutical production and Argentina enforcing bans on drug importation, Mercosur’s opposition to the EU proposals for 5 year patent extension for drugs and 10 years data exclusivity does not come as a surprise.

In fact should Mercosur accept the conditions of the EU’s Intellectual Property (IP) text, the impact on local companies would be entirely negative, as it would affect competition and restrict the number of medicines on the market. In addition, generic companies would be unable to manufacture many medicines until the patent or data protection expires.

Disagreements over intellectual property rights are also adding to the stalemate. Mercosur does not wish to accept the EU proposal for rules on copyrights and patents that are stricter than thos stipulated by the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement.

These intellectual property concerns relate to an EU requested 5 year extra patent protection to compensate for delays in registering a drug as well as to data exclusivity.

Moreover, the EU wants Mercosur countries to adopt border control measures that allow customs to officials to detain imports, exports and in transit goods suspected of IP infringement. Brazil fears further restrictions will inhibit their production of generic drugs and their ability to break patents in the occasion of national health crises.

Certainly the EU would stand to benefit from such measures, since Mercosur is an increasingly important market for the EU. However Argentina and Brazil are pumping up their national industries to reduce dependence on imports.

Should the EU’s IP measures be adopted, public health would suffer severely as medicine prices and social security expenses would rise. Adopting trips measures would also make it difficult to access generic versions of new antiretrovirals.

The next round of talks between the EU and Mercosur are set to take place in Brussels in July 2011, followed by negotiations scheduled for November in Uruguay. HAI Europe will monitor any developments.

The original article can be accessed at (subscription needed): click here

2011-06-23T12:17:00.003+02:00

EU Mercosur Trade Negotiations in July
All eyes have been on the European Union (EU)-India trade agreement, and the repercussions it will have on access to medicines, not only in India but also in the many developing countries that rely on Indian-produced generic medicines. At the same time, the EU is also negotiating agreements with the Mercosur countries (Argentina, Brazil, Paraguay, Uruguay and Venezuela). Following the last round of negotiations that took place from 2 - 6 May, in Asuncion, Paraguay another round of the EU –Mercosur trade negotiations will take place 4th -8th of July in Brussels.

See the HAI Europe Policy Brief for more information, click here

2011-06-23T11:57:00.012+02:00

HAI Europe's participation at the
"Ad hoc meeting - Bilateral trade negotiations:
State of Play"

HAI Europe will attend the DG Trade Civil Society "Ad hoc meeting - Bilateral trade negotiations: State of Play" in Brussels on the 27th of June. The purpose of the meeting is to update civil society organisations on the state of play of trade negotiations with Canada, India, Malaysia, Mercosur, Singapore and Ukraine and to allow for an exchange of views on negotiations and results. For more information, click here

2011-06-22T11:26:00.010+02:00

20 June 2011 Joint Open Letter to Commissioner Dalli on conflicts of interest at the European Medicines Agency (EMA) and the need for a review of staff regulations

On 20 June 2011, The Alliance for Lobby Transparency and Ethics Regulation (ALTER-EU), Formindep, Health Action International Europe (HAI Europe) and the International Society of Drug Bulletins (ISDB), sent a letter to the European Commissioner Dalli drawing attention to the safeguards against post-employment conflicts of interest at the European Medicines Agency and urging Commissioner Dali to initiate a review of the Staff Regulations.

The full letter to Commissioner Dali can be found below:

Mr. John Dalli
European Commissioner
European Commission
B-1049 Brussels

Open letter

Brussels, June 20, 2011

Subject: Safeguards against post-employment conflicts of interest at the European Medicines Agency and the need for a review of Staff Regulations

Dear Commissioner Dalli,

We are writing to you on behalf of the Alliance for Lobby Transparency and Ethics Regulation (ALTER-EU), Formindep, Health Action International Europe (HAI Europe) and the International Society of Drug Bulletins (ISDB), in your capacity as Commissioner responsible for the European Medicines Agency (EMA), regarding the application of Article 16 of the Staff Regulations1 on the future activities of its former Executive Director.

You will recall that questions have been asked by public health and transparency campaigners regarding the rigor of the authorisation process followed by the EMA, which allowed Mr. Lönngren to take positions in the private pharmaceutical sector within weeks of his departure from public service at the EMA.2

These concerns were recently sustained by members of the European Parliament, who moved to postpone the discharge of the EMA’s 2009 budget on the grounds that, amongst others, the Agency’s handling of conflicts of interest could jeopardise the objective evaluation of medicinal products. In its Report, the Committee of Budget Control “notes that Article 16 of the Staff Regulations grants wide discretionary power on the Management Board to allow or forbid this type of employment...” 3

Upon learning of the former Executive Director’s future employment activities, the Chair of the Management Board gave consent based on a very general and incomplete description of these future roles. Only later was a Joint Committee convened to assess if his future employment could undermine the best interests and objectives of the EMA. Subsequently, the Joint Committee imposed a set of limitations on his new and future professional activities and these limitations were later adopted by the Management Board. In a letter to EMA in May 2011, HAI Europe and Corporate Europe Observatory (CEO) expressed strong concern about the shortcomings of the limitations imposed.4

This sequence of events regarding the approval of Mr. Lönngren's job move has led us to believe that a far more coherent approach to evaluating (and preventing) potential conflicts of interest is needed. There appear to be major differences in how agencies like EMA, European Food Safety Authority (EFSA) and the European Commission itself interpret and implement Article 16 of the Staff Regulations. In all the institutions, decisions are made on a case-by-case basis but with different approaches, which is far from ideal. Our conclusion is that the current provisions regarding post-employment conflicts of interest in the Staff Regulations are not sufficiently clear.

We ask you to take this opportunity to initiate a review of the Staff Regulations. You are ideally positioned to pursue a review because the agencies under your oversight have been directly affected by its application. In our view, stronger Staff Regulations should set-out a clear, standard approach for evaluating potential conflicts of interest. As a matter of consistency, the rules and procedures for the Staff Regulations should be automatically applied when Commission and Agency staff members leave the public service, and via a clearly-defined process.

Among the changes to the Staff Regulations that we would recommend is to add a definition of what constitutes a'conflict of interest'. The responsible authorities should actively scrutinise possible conflicts of interest, including making contact with the planned employer and taking other pro-active steps. Introducing a cooling-off period of at least two years with a clear ban on Commission and agency staff moving into jobs that involve lobbying or lobbying advice would also be a logical step forward. As you will know, Commissioners currently have an 18 month cooling-off period, while for those involved in EU electricity regulation, the period is three years.5

There should also be a comprehensive online transparency around the Commission’s decision to approve or reject post-employment requests. Decisions should be immediately made available online and be searchable, sortable and downloadable.

As Commissioner responsible for the EMA, we hope that you will take up this challenge. Strengthened Staff Regulations can guard against the potential for improper influence in public agencies, such as the EMA, which is responsible for ensuring the safety, quality and efficacy of medicines in Europe. Ultimately, the appropriate application of improved Staff Regulations can secure public trust in the objectivity of decisions that can impact on public health.

Sincerely,

Olivier Hoedeman
ALTER-EU

Anne Chailleu
Formindep

Teresa Leonardo Alves
HAI Europe

Jörg Schaaber
ISDB

Notes:
ALTER-EU is a coalition of over 160 civil society groups, trade unions, academics
and public affairs firms concerned with the increasing influence exerted by
corporate lobbyists on the political agenda in Europe.

Formindep is an independent, self-funded association of health professionals
and citizens advocating for medical information and education transparent and
freed from any other interest than the patients.

HAI Europe. Health Action International (HAI) is an independent European
network of health, consumer and development organisations working to
increase access to essential medicines and improve their rational use.

ISDB. International Society of Drug Bulletins (ISDB), founded in 1986, is a world
wide Network of bulletins and journals on drugs and therapeutics that are
financially and intellectually independent of the pharmaceutical industry.
Currently it has 79 members in 40 countries around the world. ISDB journals
play an important role, helping health professionals to compare newly released
drugs with existing treatments.

1 http://ec.europa.eu/civil_service/docs/toc100_en.pdf
2 http://haieurope.org/wp-content/uploads/2011/02/25-Feb-2011-Joint-Open-Letter-to-European-Commission.pdf
3 http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+REPORT+A7-2011-0153+0+DOC+PDF+V0//EN&language=EN
4 http://haieurope.org/wp-content/uploads/2011/05/09-May-2011-Joint-Open-letter-to-MEPs-regarding-EMA-Audit-.pdf
5 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:211:0055:0093:EN:PDF

Submission to the Consultative Expert Working Group (CEWG) on alternative financing

2011-06-21T12:16:00.008+02:00

In June 2011 (HAI) Global, HAI Latin America and the Caribbean (AISLAC) and HAI Europe (HAI-E) made a submission to the Consultative Expert Working Group (CEWG) on alternative financing. For more information, see the submission below:

Submission to the Consultative Expert Working Group on Research and Development: Financing and coordination (CEWG).
June 2011

This response has been prepared by Health Action International (HAI) Global, HAI Latin America and the Caribbean (AISLAC) and HAI Europe (HAI-E)HAI is a non-profit, global network of consumers, public interest NGOs, health care providers, academics, media and individuals with over 25 years experience in representing the voice of civil society, and poor and marginalised people in medicines’ policy debates.

Our voice is one of integrity and independence from commercial and political party interests,we engage in research and evidence-based advocacy.

• HAI promotes increased access to essential medicines, the essential medicines concept and the rational use of medicines.

• HAI advocates for greater transparency in all aspects of decision making around
pharmaceuticals, for example, by reducing industry secrecy and control over
important clinical data.

• HAI promotes the rational use of medicines; that all medicines marketed should meet
real medical needs; have therapeutic advantages; be acceptably safe and offer value
for money.

• HAI works for better controls on drug promotion and the provision of unbiased and
independent information for prescribers and consumers.

Health Action International welcomes the opportunity to make a submission to the
Consultative Expert Working Group (CEWG) on alternative financing and would like to
address identified cross cutting issues.

The CEWG is faced with a great responsibility, but a responsibility that also presents an extraordinary opportunity to change the face of Biomedical Research and Development(R&D) and as a consequence to change forever the health of the world’s poor and neglected.

As such, the CEWG, should be very ambitious in its goals.

HAI would like to stress that it is of paramount importance to explore and support an
international instrument to address the coordination, financing and norm setting for
Biomedical R&D which is the only way a realistic structural change in R&D priority setting, focussed on needs-driven research can be achieved.

In the last thirty years there have been several initiatives investing in R&D for neglected diseases and improving the access to medicines for the poor. However, the focus of global biomedical R&D to a large extent remains on life-style and convenience medicines for the rich minority populations of the north, where there is a profitable market. This R&D framework is at the expense of the diseases that affect the majority population of the poor.1 A structural change needs to be made and the global health and development community looks to WHO for leadership to promote such a shift, and to implement models for innovation that structurally change the way R&D is prioritised and incentivised.

Within this framework of global norm-setting, HAI insists the scope of diseases being
tackled should not be limited and that recipient countries should be engaged in setting their own R&D needs. Moreover, in respect of financing and its allocation, HAI would like to draw attention to the importance of giving member states the opportunity to (partially) allocate their R&D contributions in their own countries, under the conditions and norms set by the international instrument.

Crucially, R&D initiatives should delink the cost of R&D from the price of the product by removing IP barriers. This will not only make new medicines more affordable, it will stimulate generic competition and ensure sustainable access. Removing IP barriers to entry into the market, will allow more players in developing economies to take part in the process of production and innovation. This is not only a desirable situation from the point of view of the right to development, but also the most effective way to ensure a sustainable supply of medicines. Generic competition has proven to be the most effective way to lower the price of medicines and ensure affordability.2

With respect to the coordination of R&D, sufficient consideration should be given to the adequate management of transparency and conflicts of interest as raised during 64th WHA by member states and NGOs.3 There must be a clear policy and systematic approach to transparency and interest declarations to ensure that those representing commercial interests are not part of policy and norm setting decision making. In this respect, we emphasize the importance of evaluating the interests of pharmaceutical companies, vaccine manufacturers, other industries, and private donors who may have complex private interests.

4 HAI recommends that a thorough comparative analysis of the proposals submitted to the CEWG though important, is not enough. It is essential for the CEWG to also give specific recommendations to member states on how to proceed with the exploration and implementation of the relevant proposals and instruments. In this respect it would be useful to identify the next steps, the lead-stakeholders, and reasonable timelines. If the CEWG does not provide such a framework on the way forward, there is a risk the process will stall.

1 WHO (2006) ‘WHO, Public Health, Innovation and Intellectual Property Rights: Report of the Commission on
Intellectual Property Right, Innovation, and Public Health’, Geneva. WHO(2004), The Global Medicines
Situation, 2004,p 19
2 World Health Organisation and Health Action International (2006) ‘Price, Availability, and Affordability: An
International Comparison of Chronic Disease Medicines’, p. 55.
3 http://haieurope.org/wp‐content/uploads/2011/05/24‐May‐2011‐NGO‐letter‐on‐Conflicts‐of‐Interest.pdf
4 HAI supports a coordinated and comprehensive approach to handling personal conflicts of interest by:
i) Adopting a common definition of conflict of interest among relevant bodies ii) Instituting the mandatory
declaration of the details regarding the activities of experts and decision makers in relation to any of the
following: employment, strategic advisory roles, consultancy, representation, financial interests, ownership of
a patent or product, researcher, employment or involvement at an institution receiving a grant or other
funding. iii) Mandating the relevant bodies to publish all declaration of interest forms iv) Creating a procedure
to identify and resolve any competing interest. In some cases, impartiality could be achieved by limiting the
advisor’s involvement in the decision making process.

HAI Europe injects public health perspective into European Research and Innovation Framework

2011-05-24T14:28:00.004+02:00

24 May 2011

Last Friday, 20 May 2011, Health Action International (HAI) Europe submitted a response to the European Commission consultation on the Common Strategic Framework (CSF) for Research and Innovation, providing feedback and recommendations for health and biomedical research within the next EU research framework. The Commission paper included important references to the societal impact of research and innovation, which was welcomed by HAI Europe.However, in many cases the paper fell short of promoting the public interest in policy-making, and maintained a narrow focus on innovation linked to commercial benefits.

As a patient and consumer organisation, HAI Europe’s response sought to inject a citizenbased perspective, in particular for the future of European health and medical research. The response reviewed the Commission’s paper from a public health perspective, analysing the conclusions based on how well they rise to the challenge of demographic ageing, a period of severely constrained healthcare budgets, and the sustainability of European healthcare systems. In this context, the omission of health as a societal challenge was disappointing.

“In the EU, and around the world, we are seeing government price cuts and a problem of access to innovative medicines, which is a reflection of the flawed sustainability inherent in the current R&D model,” says HAI Europe Projects Officer, Terri Beswick. “The new research and innovation framework marks an opportunity for EU leadership on alternative models of medical research and innovation that promote public health goals; where societal impact means healthy citizens, not just healthy profits.”

HAI Europe’s response outlined two specific initiatives that should be advanced in the next CSF: Equitable Licensing and Exploration of New Models of Innovation (in particular, innovation inducement prizes). ‘Public funds for public good’ is the overarching principle behind equitable licensing. Several equitable licensing provisions are directly applicable to the EU research context and goals. In particular, award criteria that ensure access to outputs and knowledge as a fair and reasonable return for the investment of public funds collected from European tax-payers.

The response also called for exploration of new models of innovation in the next CSF, in the form of pilot programmes for inducement prizes, or feasibility studies for alternative models. This is in line with the EU’s own commitments to explore R&D funding with incentives that dissociate the cost of R&D from the price of products, thereby promoting access and research collaboration that is currently thwarted by increasing IP protectionism.

HAI hopes that the results of the consultation, which are due to be presented at an EU Commission event on 10 June 2011, take account of public interest perspectives, and demonstrate a shift towards health and medical research and innovation that seeks to bring about positive and valuable health impacts to European societies.

***
The full consultation response is available at: http://haieurope.org/wp-content/uploads/2011/05/20-May-2011-Consultation-Response-DG-Research-Green-Paper.pdf

For more information please contact:
Terri Beswick: terri@haieurope.org or Sophie Bloemen: sophie@haieurope.org

Statement on Conflicts if Interest delivered at WHA on behalf of HAI, Berne Declaration, KEI, TWN, PHM, IBFAN

2011-05-20T11:40:00.001+02:00

Today Health Action International, represented by one of its members, Patrick Durisch, delivered the following statement at the World Health Assembly in Geneva on Agenda Item 13.5 Global Immunization Vision and Strategy

64th WHA, item 13.5, 20.05.2011

Statement on the management of conflicts of interest in global immunization governance

Thank you, Mr Chairman, for this opportunity to address the member states and express our concerns about governance of the World Health Organization (WHO) and other public health bodies, as regards the management of conflicts of interest in global immunization governance. This is a joint statement from Health Action International, Knowledge Ecology International, Third World Network, the Berne Declaration, the People’s Health Movement and IBFAN.

WHO and other public health institutions have complex relations with commercial entities that supply health care products and services. In some cases the commercial entities are subject to or in need of regulation, in order to protect consumers and promote the public interest. Public health institutions are also often engaged in buying goods and services, or providing financial assistance for such purchases.

It is therefore widely recognized that governments and public health institutions like the WHO must avoid conflicts of interest in all aspects of governance. WHO can only respond meaningfully to the challenges of public health through greater transparency and accountability guided by the priorities of Member States and the advance of public interest. However, transparency is a necessary but not sufficient safe guard: there must also be a clear approach and policy to ensure that those representing commercial interests are not part of policy and norm setting decision making.

We are concerned that proposals for the governance of the decade of vaccines, do not adequately address the management of conflicts of interest, and present an unrealistic and empirically unsupported assumption that all stakeholders will collaborate to advance the public interest.

We ask the WHO members to ensure that any changes in governance structures address in a realistic manner the risks that conflicts of interest will frustrate efforts to protect consumers and the public interest. In this regard, we emphasize also the importance of evaluating the conflicts of interest by pharmaceutical companies, vaccine manufacturer, other industries, and private donors who have complex private interests.

Specifically, we ask WHO members to guard against initiatives that will give private interests and donors a greater role in WHO governance. For this reason, we are calling on member countries to oppose the governance of the Decade of Vaccines, as well as the proposed WHO reform.

Thank you, Mr Chairman.

Conflicts of Interest and the Future of Financing for WHO.

2011-05-17T23:38:00.009+02:00

Statement on WHO governance and the Management of Conflicts of Interest and the Future of Financing for WHO.

We write to express our concerns about governance of the World Health Organization (WHO) and other public health bodies, as regards the management of conflicts of interest.

We are concerned that proposals in the current debate over WHO reform, particularly in the report on ‘The future of financing for WHO, World Health Organization: reforms for a healthy future’, do not adequately address the management of conflicts of interest, and present an unrealistic and empirically unsupported assumption that all stakeholders will collaborate to advance the public interest.

We ask the WHO members to ensure that any changes in governance structures address in a realistic manner the risks that conflicts of interest will frustrate efforts to protect consumers and the public interest. In this regard, we emphasize also the importance of evaluating the conflicts of interest by pharmaceutical companies, vaccine manufacturers, the processed food industry, the nuclear power industry and other industries that cause environmental contamination and private donors who have complex private interests.

Specifically, we ask WHO members to guard against initiatives that will give private interests and donors a greater role in WHO governance. For this reason, we are calling on member countries to oppose the World Health Forum and the governance of the Decade of Vaccines.

Berne Declaration

GTPI/Rebrip

Health Action International (HAI)

IBFAN

Knowledge Ecology International (KEI)

Médecins Sans Frontières (MSF)

Oxfam International

People's Health Movement (PHM)

Third World Network (TWN)

Universities Allied for Essential Medicines (UAEM)

DG Trade public hearing on the “Protection and enforcement of IPR in third countries

2011-05-10T23:09:00.003+02:00

Today, DG Trade held a public hearing on the “Protection and enforcement of IPR in third countries” from 9.00-13.30, at the Albert Borschette Conference Centre in Brussels

Health Action International (HAI) Europe attended the hearing and was given the opportunity to present.

The hearing was a welcome, but rare, opportunity to engage directly with the Commission on its external trade policies. It was chaired by Anders C. Jessen, Head of Unit for Public Procurement and Intellectual Property at DG Trade, who was appointed last October. The opening tone of the meeting was one of willingness to engage, which was welcomed, in particular by the civil society groups present. There was sufficient time devoted to discussion, and an opportunity for six stakeholder presentations at the start of the meeting, of which HAI Europe was the sole civil society voice.

HAI Europe's Terri Beswick gave a presentation which emphasized the following points:

Urging the EU:

• to use caution in exporting their acquis on enforcement to third countries

• not to require other countries to adhere to ACTA through for example bilateral trade agreements

In response to the presentation there was more openness from DG Trade in acknowledging the possibility of negative development impacts, but without assuming responsibility for determining those impact as part of their mandate.

The presentation also noted:

• the absence of reliable data on IP infringements

A number of presentations from industry representatives continued to conflate counterfeiting and quality and safety issues. HAI Europe made further interventions reiterating the need for a separation of these issues, both in discussions around IP enforcement, and in data that is used to justify enforcement initiatives in order to present a more balanced picture of the impact of infringements.

• the costs and negative impact on health of additional IP enforcement measures

Technical assistance programmes were highlighted by the Commission as important tools of enforcement. But HAI Europe again intervened to outline the problems with this approach. Namely, that the use of development funds to ‘train’ IP enforcement agents was an inappropriate use of funds that are ultimately diverting public resources of third countries and EU public aid funds towards protecting private rights of European industries. We also noted that the negative impact on competition from overreaching IP enforcement could have the perverse effect of requiring increased EU development aid to cover the higher costs of medicines from monopoly medicines markets.

• the need for impact studies on the costs and welfare implications of IP Enforcement, urging the Commission to engage in impact studies.

The Commission’s response to our call for impact studies to measure the welfare implications of IP enforcement was disappointing. They maintained that, as external consultants conduct the Commission’s impact studies, it was the responsibility of the consultancies to determine which subjects were worthy of investigation. We strongly believe that the Commission should take on the task of establishing data on the welfare costs associated with its own IP enforcement strategy. The need is even more pressing given the Commission’s increasing activity on pushing for new heights of IP enforcement standards.

• the lack of civil society inclusion in the consultation processes around enforcement, urging the Commission to be more inclusive.

The Commission was open to more civil society input and noted the low participation of civil society groups in comparison to industry. However, it is not currently doing enough to ensure that the significant asymmetry of resources that allow commercial actors to dominate in consultation mechanisms is addressed through better outreach to civil society groups that have valid and legitimate contributions to make on trade policy. We believe that a better balance in input to Commission policies is a vital part of securing more balanced EU trade policy, and call on DG Trade to put in place proactive outreach strategies for actors that are underrepresented in consultation processes.

Many of the concerns raised in our presentation were also noted in the ADE report http://trade.ec.europa.eu/doclib/docs/2010/november/tradoc_147053.pdf , and evaluation of the Commission’s IP Enforcement Strategy in third countries, which was commissioned by the European Commission itself and published in November 2010. The report takes a critical of the EU Strategy and notes the dilution of goodwill from third countries caused by a dogmatic approach adopted by EU trade staff.

EU-Mercosur Trade Negotiations: What Fate for Access to medicines?

2011-04-29T19:19:00.002+02:00

Trade negotiators from the EU and Mercosur countries (Argentina, Brazil, Paraguay, Uruguay and Venezuela) will meet next week from 2 to 6 May in Asuncion, Paraguay for the latest round of negotiations toward an Association Agreement between the two blocs, and public health advocates are watching with concern. Access to medicines in emerging and developing countries may come under threat if the EU continues to push for its over-reaching intellectual property (IP) demands in the trade pillar. Discussions on IP issues as part of the EU-Mercosur Association Agreement already started during the last round of negotiations in March this year, and it is likely that the two sides will present negotiating texts in Asuncion next week.

The EU’s IP demands in the EU-India trade negotiations have already sparked great controversy amongst civil society, international agencies, and developing country governments, and the Indian government recently rejected EU proposals on data exclusivity. India’s role as the “pharmacy of the developing world” would have been compromised, as well as access to affordable generic medicines not only in India, but also in the many countries that rely on Indian-produced generics.

Mercosur negotiators must also stand firm to resist EU demands for IP provisions that have damaging consequences for public health. As part of the Global-Latin American and Caribbean Alliance for Access to Medicines, HAI Europe works closely with civil society in Mercosur countries to raise awareness and campaign to ensure that health budgets and access to medicines in the region are not put under further strain as a result of a trade agreement with the EU.

Published ahead of negotiations, a HAI Europe Policy Brief highlights the adverse effects of stringent IP provisions proposed by the EU in trade agreements, including proposals on data exclusivity, patent extensions, and IP enforcement, which can have disastrous effects on access to medicines; weakening competition from generic medicines and sustaining monopoly prices.

The complete policy brief is available at: http://haieurope.org/wp-content/uploads/2011/04/29-Apr-2011-Policy-Brief-EU-Mercosur-Protecting-Access-to-Medicines.pdf

For more information please contact:

Terri Beswick: terri@haieurope.org or Sophie Bloemen: sophie@haieurope.org

Foundations: Conlicts of interests and Democracy issues

2011-04-29T19:02:00.004+02:00

http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001020

The article ‘Global Health Philanthropy and Institutional Relationships: How Should Conflicts of Interest Be Addressed? ‘ published in Plos Medicine on the 14^th of April on conflicts of interest in private philanthropic foundations addresses a realm of governance and transparency issues that has not received adequate attention in the global public health community.

The article notes that increasingly, private actors in the form of foundations take an important role in setting priorities and directing policy in public health. The Gates foundation as the prime example, with a budget exceeding that of the WHO, funds a huge component of the organisations engaged in global public health and medical innovation, as well as journalists, newspapers and the WHO itself. This gives the them a huge agenda setting capacity, just as other foundations with impressive budgets like the Ford Foundation, the Kellog Foundation, Rockefeller, although to a lesser degree.

The issue of conflicts of interests is well documented by the article, particularly for the Gates foundation, where there are some issues with stocks in pharmaceutical companies and coca cola, and board members or members of management committees with ties to interested corporate actors, including pharmaceutical companies. Although giving a wide-ranging overview of the conflict of interest issues, it does not mention the fact that at this time policy discussions around the current model of innovation and the patent system are paramount and many believe alternative models are necessary to structurally improve access to medicines. The Gates Foundation is obviously well positioned to influence this debate, but when taking in to account that the pharmaceutical companies the Gates Foundation has ties with might not see this as beneficial to their corporate interests one can see the obvious conflict of interest and its potential far reaching consequences. Furthermore, shifting away from intellectual property rights to incentivize innovation might not be obvious for a foundation who’s fortune is based on those rights, although in another field, -software.

The conflicts of interest are very problematic and should be avoided and scrutinized, however, they do not so much constitute a shocking fact in itself, and some of them are arguably inevitable. What the article shows clearly is that what makes then so worrisome is the enormous influence these organisations have on communities and policy throughout the world, without a democratic feedback system or ‘checks and balances’ in place. This is the larger political issue, the political economical situation that makes these conflicts of interest so very problematicIt relates to broader concerns that funding for global health has shifted from institutions accountable to a relatively broad constituency, such as the WHO, to those with limited accountability, such as the Gates Foundation.

The question is of course, how does the global community solve this? Could we say that the fact that an organisation or foundation has an unchallenged influence over issues that affects the well being of a community, establishes the duty for that organisation to include them in the decision making process? Or, the right to self determination establishes the claim by communities to be part of the decision making process in these foundations? The tax exemption argument in the article gives some sort of claim to society to claim to be involved: the foundations are tax exempt and the capital would have been taxed and redistributed by the government if not donated to philanthropic foundation. But this is more relevant for the principle that these foundations can not engage in activities that are to the advantage of corporate actors, which is in the US rules for tax-exempt regulations.

How do we implement checks and balances or democratic processes for private foundations? The authors of the article suggest that in order to align aid with community needs, ’’ foundation investment and program portfolios should incorporate representation from the intended recipients of its support’’. Yet, how does this work in practice? Would it be similar to the European employee boards that have a role in the corporate governance of companies? Would the civil society that takes part be funded by Gates? And can we demand this, how do we force this on foundations? By moral pressure, international law, a UN resolution?

Of course, many will still be tempted by the arguments that these actors can spend their own money in whatever way they want too. This view probably enjoys sympathy especially in the US, where the idea that private actors have a huge role in shaping society in a rather unaccountable way is much more common than say, in Europe.

In any case, it seems reasonable to suggest that it is high time for the global public health community to think harder about governance structures that would provide these democratic mechanisms, and provide checks and balances for the foundations that rule our worlds.

Sophie Bloemen

HAI has researched how corporate support for patient organisations is associated with their positions in health policy. There is a conflict of interest between organisations’ central goal of representing patients’ needs and their secondary objective of securing funding from companies who sell medicines or medical devices. Our concern is that corporate interests could override the patient voice in medicines policy debates. To read more about HAI Europe’s research in this area, please visit: http://haieurope.org/work-areas/democratisation-of-medicines-policy-2/promoting-independent-patient-organisations/

European drug regulator challenged over revolving door case involving former Director

2011-02-25T16:17:00.001+01:00

Public health and transparency advocates ask the European Commission if rules regarding conflicts of interest have been sufficiently and duly respected in light of the EMA's decision to allow its former Executive Director to work within the private pharmaceutical sector just weeks after leaving his position with the drug regulatory agency.

Read the joint open letter

Read the joint press release

2011-02-24T12:22:00.001+01:00

Dear All,

Joint Open Letter Calling Novartis to cease seemingly endless legal process in India

24 February 2011

Health Action International (HAI) Europe, in collaboration with Berne Declaration, HAI Africa, HAI Asia Pacific, Third World Network and Knowledge Ecology International, have urged the pharmaceutical company Novartis to put an end to its five year legal actions in India regarding the patenting of the anticancer drug Glivec. The NGOs also called on the Swiss company to refrain from attempting to influence the Indian government over laws and policies that would hinder access to medicine.

In a joint Open Letter sent last Tuesday to Novartis’ President, Dr. Vasella, the signatories voiced their concern regarding Novartis’ persistent legal actions in regards to the patent application for Glivec (Gleevec in the USA), a vital medicine in treating relatively rare forms of leukaemia and gastro-intestinal tumors.

Despite three consecutive patent refusals pronounced by the Indian justice authorities since 2006, the pharmaceutical giant, through an appeal to the Supreme Court in August 2009, is insitant in its attempt to challenge the Indian Patent Law. The Open Letter strongly urges Novartis to drop this pending case. Domestic NGOs have organised simultaneous protest events throughout India, and will remain mobilised until the next hearing of the Glivec case at the Supreme Court scheduled for 19 April this year.

The Open Letter also urges Novartis to abstain from lobbying the Indian government for more stringent intellectual property regulation. This would have major negative impact on access to medicines for disadvantaged patients and would undermine competition with generic equivalent medicines. These particular issues are currently being negotiated in the framework of bilateral free-trade agreements between India and the European Union, and the European Free Trade Association.

The Open Letter follows a public call made by Patrick Durisch, health programme Coordinator of Bern Declaration, a HAI Europe member organisation, during the Annual General Meeting of Novartis’ shareholders last Tuesday. Durisch underlined the negative consequences of this judicial saga:

“The stakes go far beyond the granting of the patent for this anticancer drug. This action aims at weakening a public health safeguard clause – section 3(d) of the Indian Patents Act – which limits the multiplication of abusive or useless patents on an already-known substance”, said Mr Durisch. “Without this disposition, access to affordable medicines would be threatened in most developing countries, since India is one of the primary suppliers of generic medicines worldwide, in particular in the field of HIV/AIDS.”

***

The complete version of the Open Letter is available here

For more information please visit: www.ladb.ch/Glivec

Or contact Patrick Durisch: durisch@ladb.ch, +41 79 413 60 15

Corporate funding linked to EU patient & consumer groups policy

2011-02-01T16:54:00.002+01:00

HAI Europe’s latest research has established a link between patient and consumer groups’ perspectives on EU medicines policies and the funding they receive from the pharmaceutical industry.

Please see our Press Release, as well as the two-page Factsheet and complete Research Article (links to website)

Apply now: HAI Europe recruits two interns for 2011

2010-12-22T12:51:00.003+01:00

HAI Europe is recruiting two volunteer interns to begin in early 2011. The successful applicants will gain valuable experience of working in an international advocacy NGO and exposure to the EU policymaking environment.

Communications Volunteer Internship

Project Assistant Volunteer Internship

Applications will be accepted by Rose (Rose@haieurope.org) until 7 January 2011. Please clearly indicate which volunteer internship you are applying for.

Please circulate these notices in your network.

We look forward to receiving your application.

EMA reviews transparency criteria

2010-12-20T17:30:00.009+01:00

The European Medicines Agency (EMA) has launched an internal review of the transparency criteria that patient and consumer organisations need to fulfill in order to be eligible to work with the Agency.

Read the eligibility criteria approved in 2005 (transparency guidelines are on page 2)

HAI Europe proposes these changes to the transparency criteria (added text in bold):

Transparency: The organisation should publicly disclose its sources of funding both public and private by providing the name of the public and/or private bodies and their individual financial contribution both in absolute terms and in terms of percentage of the organisation budget. This information should be updated on an annual basis. The organisation should provide the EMA with a link to its website where this information can be found.[1] Any relationship with corporate sponsorship should be clear and transparent. Any conflict of interest[2] should be publicly disclosed and submitted to the EMA. The reference to private bodies does not include private individuals unless this presents a potential conflict of interest as referred to above.
In case of umbrella organisations the list of member associations should be made available.
EMA encourages organisations to be as transparent as possible, e.g. by regularly publishing, on the organisation website the financial information as specified above as well as a report of the activities undertaken.

[1] This link will be included under the Organisation’s description on the EMA’s webpage titled ‘Organisations involved in the Agency’s Activities’

[2] A conflict of interest is defined as a direct or indirect interest in the pharmaceutical industry, in line with definition established in the ‘European Medicines Agency policy on the handling of conflicts of interests of Scientific Committee members and experts’ published on 13 October 2010.

Stay tuned to find out what final text is agreed in 2011.

HAI research on financial disclosure featured in article: European politicians' call for greater transparency

2010-12-01T15:41:00.004+01:00

The physicians' magazine Deutsches Aerzteblatt highlights HAI Europe's research on financial dislcosure & transparency of patient and consumer groups in an article examining European politicians' call for greater transparency of the relationships between European patient organisations and the pharmaceutical industry

Read the article Europäische Patientengruppen: Fragwürdiges Finanzgebaren (in German)

Invitation: Meeting to discuss Global Health Education (GHE) and the People's Health Movement (PHM) in Europe

2010-11-24T12:07:00.004+01:00

You are invited to attend a follow-up meeting to discuss Global Health Education (GHE) and the People's Health Movement (PHM) in Europe. The meeting is meant to be an open laboratory for joint discussion and work; there will be plenary sessions for introduction to the works and final discussion and conclusions, and a core part dedicated to working in groups on issues dealing with GHE and the PHM in Europe.

A few more details about the event:
- Date: 4-5 December 2010
- Time: 14:00 on Saturday to 14:00 on Sunday
- Venue: Rathaus Schöneberg, John-F.-Kennedy-Platz 1, 10825 Berlin (Casino Room)
- Registration (which is of course free of charge!)

The organisers would very much appreciate it if you could register as soon as possible, and in any case before Tuesday, November 30th: we need to know how many people will attend in order to finalize the last logistic details.

Also, if you know people who might be interested in participating, please feel free to circulate this invitation.

Finally, please note that - as previously announced - Medico International has kindly offered travel subsidies: if you would like to apply, please contact Andreas Wulf (wulf@medico.de).

(Please note that this is not a HAI Europe meeting, but we are happy to circulate this announcement on behalf of the organisers)

ACTA, Democracy & Access to Medicines

2010-10-25T11:50:00.005+02:00

See ACTA text here

Briefing Note for Members of the European Parliament by HAI, TACD, MSF and Oxfam

PDF version here

Negotiations are not the end of the road - ACTA is a blank cheque for the future

In a move that would circumvent open debate and due scrutiny, the agreement proposes an annual meeting of signatories where amendments to the Treaty can be negotiated. Even some of the most contentious issues that have been removed during the negotiations could, within a year, be back in the text once ACTA is out of the public spotlight. Any future changes to ACTA must be subject to public scrutiny by all stakeholders and must receive parliamentary approval. (ACTA, Art. 6.4: Amendments, Arts. 5.1.2. 5.1.4)

Changing EU foreign policy through the back door: Circumventing WIPO and WTO

International agreements on intellectual property fall under the purview of the World Trade Organisation (WTO) and World Intellectual Property Organisation (WIPO). The EU has, together with the other ACTA negotiating parties, bypassed these multilateral institutions. ACTA is designed and intended to be expanded and become a global standard. Once ACTA is established, we are likely to see a push to expand the number of signatory states. ACTA effectively will establish a new institution where European Parliament scrutiny is absent and where stakeholders, such as civil society, are not represented as they are in these multilateral institutions. This is a regressive step with regards to EU democratic processes and multi stakeholder involvement.

The ACTA process constitutes an explicit de facto EU foreign policy choice which has far reaching implications for EU foreign policy. These EU foreign policy repercussions of ACTA have not been debated nor considered by the European Parliament, especially with reference to developing countries should be evaluated, studied and publicly debated.

ACTA will hurt Access to Medicines: remove patents from scope of the agreement

Generic competition is key for bringing down prices and ensuring access to affordable medicines around the world. The disproportionate enforcement measures proposed in ACTA: damages, injunctions and other remedies, will inhibit generic competition through excessive persecution of possible IPR violations, strengthen monopolies on medicines and enhance the rights of brand pharmaceutical companies at the expense of access for the poorest citizens. ACTA’s IPR enforcement measures would be a strong barrier against price-reducing generic competition and would jeopardise the free flow of legitimate medicines across borders.

The name Anti Counterfeiting Trade Agreement does not accurately represent the contents of the agreement. ACTA would be better referred to as an ‘Intellectual Property Enforcement Treaty’ as it encompasses many categories of intellectual property rights. ACTA does not only affect counterfeiting, which relates to trademark law, but also patents, copyright, data protection, geographical indications, integrated circuit protections, trade secrets, and other laws. Counterfeiting is related to wilful and commercial scale trade mark infringement only. Raising patent protection will not protect patients but hurt them.

The scope of the agreement overreaches and is too broad: the agreement should be limited to commercial scale counterfeiting and piracy. Most importantly, patents and civil trademark infringement should be removed. (ACTA, p6. Article 1.X: Definitions)

Patents

Including patents in ACTA will without question hamper generic trade, innovation and access to medicines. As the equivalents of existing brand medicines, generics are closely linked to patent law, and can only enter the market when there is no patent or when the patent has expired. The level of protection for patents has already been established under the TRIPS Agreement, and there was an effort to balance IPR rights with the right to access to medicines. Advancing patent protection further by means of excessive enforcement provisions will undermine the balance found in TRIPS.

The EU negotiators have been pushing to include patents in ACTA whilst the US and other parties have included a footnote in brackets that excludes patents. To protect access to affordable medicines, patents must be excluded from the agreement. (ACTA, Ch II.Sect. 2: Civil Enforcement)

Damages, injunctions and other remedies: A chill on innovation and competition

The current wording on damages in the text could allow for excessive damages for infringement that go beyond current standards, and which could have a strong dissuasive effect on generic competition. By increasing the damages to this extent the agreement effectively expands the rights of the IP right-holder, increasing the risks and decreasing the viability for competitors seeking to enter the market. This will dampen innovation and the production and trade of generic medicines.

The proposed high levels for damages and penalties will affect the laws in some EU Member States. Damages based on suggested retail price go beyond the acquis. Regarding destruction of infringing goods and production facilities, the acquis has more checks and balances than ACTA. Injunctions against a third party are more limited in the acquis than under ACTA, the acquis also has broader exceptions. (ACTA. Ch II.Sect.2. Art. 2.2)

ACTA puts third parties—such as distributors and even non-governmental organisations or public health authorities—at risk of severe penalties

Third parties are at risk of injunctions, provisional measures, and even criminal penalties, including imprisonment and severe economic losses. All of these are TRIPS-plus and with potentially far-reaching consequences. This could implicate, for example, suppliers of active pharmaceutical ingredients used for producing generic medicines; distributors and retailers who stock generic medicines; NGOs who provide treatment; funders who support health programs; and drug regulatory authorities who examine medicines. This could act as a significant deterrent to anyone involved in the production, sale and distribution of affordable generic medicines. (ACTA Ch. II, Sect. 4, Arts. 2. 14.4, 2.15, 2.16.)

ACTA undermines due process and judicial guarantees

ACTA undermines the judiciary by allowing extra-legal processes: it would limit access to due process for IP challenges by permitting the seizure and destruction of medicines without notification of the owner, providing the owner with the opportunity to respond, or mandating judicial oversight. Such ex parte measures are susceptible to abuse. Even where judicial process is mentioned, the balance lies heavily in favour of the rights-holder alleging infringement. Under ACTA there is limited power to balance health issues against the interests of private companies. The cooperation of IPR rights holders proposed in ACTA with authorities should be balanced by fair, legal hearings with the participation of the parties accused of the violation. (ACTA Ch. II, Sec. 3, Art. 2.11.1.)

Inclusion of Civil Trademark infringement: A problem for Access to Medicines

ACTA could still constitute barriers to medicines going to developing countries

Civil trademark disputes on similar labelling do not pose threat to public health. Yet far reaching enforcement can pose threat to access to medicines.

ACTA could increase border searches and interfere with the transit of legitimate medicines. The border measures section no longer includes patents yet still includes civil trademark infringement with increased penalties. This means a customs official could initiate a seizure and even destruction of an allegedly infringing good without judicial review or even notification to the rights holder—on the basis of an assertion of a commercial trademark dispute. This is illustrated by the German detention case for alleged trademark infringement(regarding Amoxicilin). The scope should be limited to wilful commercial scale trademark infringement where fraudulent exact copying of the labelling and branding is the case.. (Compare ACTA Ch. II, Sec. 3 with TRIPS Ch. III, Sec. 4, Art. 59., ACTA Ch. II, Sec. 3, Art. 2.X: Scope of the Border Measures)

If ACTA is finalized, the following significant changes would be necessary:

• ACTA should only be applicable to wilful copyright infringement on a commercial scale. It should exclude both patents and civil trademark infringement from the scope of the agreement.

• No action should be taken by authorities without due process and full judicial review with the participation of the alleged infringer.

• Protections against abuse must exist, including access to information for the alleged infringer, and the obligation to consider proportionality and the public interest in setting the remedy.

• ACTA should not mandate excessive punishment for alleged civil infringement. Civil and criminal enforcement should not be TRIPS-plus or nor require a change in a state’s laws or the acquis.

• ACTA should not establish third party liability nor penalties for "aiding and abetting".

• Any institutional structure established should be open and transparent. It should not have the authority to amend ACTA without public scrutiny and approval from democratic bodies, such as the European Parliament.

• The EU should commit to refraining from proposing the ACTA agreement as a requisite for EU- Third-party free trade agreements.

Selling Sickness through unbranded disease awareness campaigns?

2010-10-22T14:25:00.003+02:00

European legislation prohibits advertising of products that have prescription-only status, as well as stating that advertising of medicinal products, when it is allowed, should neither be misleading nor inconsistent with the summary of product characteristics.

Key relevant underlying principles within the European legislation and the WHO Ethical Criteria for Medicinal Drug Promotion include avoidance of activities that take undue advantage of people’s concerns for their own health, and promotion disguised as scientific or educational activities.

In this presentation (download), Teresa Alves has used illustrative case studies to explore the nature and content of the information provided by pharmaceutical companies about medical conditions and their diagnosis and treatment. Cases include a range of situations including chronic disease treatments, controversial expensive new drugs, disease prevention strategies, and lifestyle conditions.

The analysis of case studies brings up questions concerning the public health implications of the information that is provided by companies, as well as the potential risks and benefits for citizens. Are companies providing useful information or expanding markets to sell their products?

HAI Europe Statement: EMA talks the ‘conflicts of interest’ talk, but will it walk the walk?

2010-10-22T14:15:00.002+02:00

18 October 2010 – The European Medicines Agency (EMA) has taken a step in the right direction by adopting an improved policy to handle potential conflicts of interest among its scientific committee members and experts. Independence in scientific and expert advice is crucial to balanced decision making. Conflicts of interest (CoI) can bias regulatory affairs, and compromised decisions could result in the market approval of medicines of questionable efficacy or unproven safety, which would ultimately put citizens at risk.

The Agency has re-iterated its commitment to transparency by pledging to publish all committee members’ and experts’ declarations of interest online. The EMA will also ‘pro-actively’ screen all declarations of interest prior to the individual’s formal nomination by the competent authorities. These standards can only be effective if the Agency takes the responsibility for their enforcement and compliance. HAI Europe encourages the EMA not only to pro-actively screen the declarations, but also to verify their accuracy. Experts’ participation in EMA activities should be conditional on the complete and public disclosure of any potential conflicts of interest.

Furthermore, the new policy still raises some unanswered questions:

Given the number of exemptions made for ‘expert witnesses’, how can the impartiality of this advisory position be ensured?
Deadlines for interest disclosure and implications for failing to uphold or adhere to this policy were curiously absent from the Agency’s statement. The policy could easily flounder if the EMA does not commit to continuous monitoring of its application and to establishing clear consequences for non-compliance.
As this improved policy to handle conflicts of interest has been said to apply only to the scientific committees, will the Agency also be revisiting and issuing a CoI policy vis-à-vis the Management Board?
Participation in the Patient and Consumers’ Working Party (PCWP) and in the Healthcare Professionals’ Organisations Working Group is governed by different criteria. Will the agency be reassessing criteria soon, based on recent reports on CoI and corporate sponsorship at PCWP level?

HAI Europe maintains that the Agency’s financial and intellectual independence from the pharmaceutical industry remains an essential component of sound regulatory decision making. The EMA’s improved policy on conflicts of interests could strengthen independent scientific and expert advice, provided that the policy is properly implemented and monitored. It’s a case of wait and see.

Report: Public information as a medicines marketing tool

2010-10-22T14:10:00.005+02:00

A recent report from Healthy Scepticism / Gezonde Scepsis describes ways in which pharmaceutical companies provide the public with information about diseases and conditions. It provides an overview of the various methods used, and the impact that public information campaigns can have.

The aim of this report is to demonstrate how companies use public information campaigns about diseases and conditions as tools to market their medicines. In the research, the authors Sandra Nuland and Zamire Damen have carried out three case studies to demonstrate how various methods are applied and the parties are involved.

Read the report Public Information as a Marketing Tool

Systematic review of drug promotion's influence on prescribing

2010-10-22T14:06:00.002+02:00

An important new systematic review on the content and effects of drug promotion is just out in PloS Medicine, featuring HAI Europe members Joel Lexchin and Peter Mansfield as co-authors.

Read the article Information from Pharmaceutical Companies and the Quality, Quantity, and Cost of Physicians' Prescribing: A Systematic Review

Doha Declaration Par 6 to be reviewed in TRIPS Council

2010-10-18T15:55:00.006+02:00

On the 27th of October WTO members will discuss the 'health waiver' of Paragraph 6 in the Doha Declaration which allows countries to issue a compulsory license for export, enabling access to medicines in countries without sufficient manufacturing capacity.

So far this mechanism has only been used once, and has proven to be very problematic and by some deemed as unworkable.

After much resistance by some developed countries to adress the issue, now an entire day will be devoted during the TRIPS Council to reviewing this mechanism. Why has it not been used more often? And can the mechanism be improved? , are questions that deserve to be posed and need to be answered as the problem of access to medicines has most definitely not been solved.

See IP watch article for more information

Welfare Implications of Intellectual Property Enforcement

2010-10-06T18:30:00.004+02:00

HAI staff contributed to a paper on the Welfare Implicationns of Intellectual Property Enforcement which was published in the PIJIP Research Series at the American University in Washington DC, available at : http://digitalcommons.wcl.american.edu/research/.

Abstract

The enforcement of intellectual property rights is often presented as a neutral legal phenomenon aimed at ensuring compliance, or giving effect or force to a law. Enforcement of intellectual property rights has gained increasing international attention and legal strength. More and more, existing international substantive standards are being supplemented with secondary norms, which in principle deal with the fulfillment of the former. However, the value placed on these secondary norms and intellectual property enforcement initiatives contrasts with little knowledge or understanding of their implications for resources and overall welfare. Moreover, the aforementioned neutrality recedes when it becomes apparent that some of the enforcement provisions contained in treaties, in fact, constitute a substantive expansion of rights instead of merely adding secondary norms of adjudication. This trend requires a much better understanding of what enforcement signifies and what the costs of implementing international intellectual property commitments may be, taking account of its effect on the economy and on society as a whole. This understanding may be particularly important when a lack of ownership of the agreements setting up new enforcement obligations exists, namely, when some of the parties are pursuing goals distinct from those mentioned in the text of the agreement.

A useful analytic tool with regard to the definition of enforcement can be found in the distinction between primary and secondary norms, with enforcement norms falling into the category of secondary norms of adjudication. Additionally, when considering the resource implications of enforcement, it is import to distinguish between the costs of enforcement and the welfare effects of enforcement. The costs of enforcement represent the investment a country makes in order to adequately comply with the commitments it has made, whilst the welfare effects denote the impact of new enforcement measures, assessed using variables that stem from the initial economic variables affected (i.e. production, exports, imports, investment). These changes in turn affect consumption and access to public goods, expenditure and welfare.

This conceptual framework leads first to seek to identify the costs of adequately complying with a treaty, and second to devise a methodology that allows, in a case-specific manner, to identify the impact or effects of enforcement measures on the economy and on society as a whole.

Seuba, Xavier, Joan Rovira, and Sophie Bloemen. 2010. Welfare Implications of Intellectual Property Enforcement Measures. PIJIP Research Paper no. 5. American University Washington College of Law, Washington, DC.

Dutch Minister of Health supports HAI E's financial transparency recommendations to EMA

2010-09-23T14:53:00.005+02:00

In response to a series of parliamentary questions from Socialist Party parliamentarian Van Gerven, the Dutch Minister of Health, Wellness and Sport supported the recommendations in HAI E’s latest research article to aid the enforcement of the European Medicines Agency (EMA) financial transparency guidelines for patient and consumer groups.

The Minister advises the Agency to take HAI E’s recommendations “to heart”, agreeing that all (financial) information gathered from these organisations should be publicly available on the EMA website and that the organisations’ participation in the Agency’s activities should be conditional on the fulfillment of the transparency criteria.

Continue reading Minister Klink's response to all 11 parliamentary questions.

Report exposes how Big Pharma has hijacked EU-India trade deal

2010-09-02T12:28:00.007+02:00

The livelihoods of millions of patients are at risk under the terms of a new trade deal being negotiated by the EU and India which has been hijacked by big business, highlights a new joint report from Corporate Europe Observatory and India FDI.

"Trade Invaders – How big business is driving the EU-India free trade negotiations" includes a case study on the demands of the pharmaceutical industry, describing how Indian generic drug-makers would be obliged to repeat the innovator companies' costly and time consuming tests because public authorities could no longer rely on their test data to approve the generic drug. This could delay or even prevent the registration of medicines and price competition through generics.

Big Pharma also wants an extension of the standard life of patents from 20 to up to 25 years and enforcement measures including provisions allowing the seizure of products suspected of infringing intellectual property rights at the Indian border, which could hamper legitimate trade in generics.

Continue reading the report...

In perspective: EMA comments on HAI Europe's survey of financial disclosure

2010-08-30T11:14:00.007+02:00

The European Medicines Agency's (EMA) response to our research article surveying the effectiveness of the Agency's financial disclosure guidelines, has been reported in the following publications:

SCRIP Intelligence European regulator rejects study criticising patient organisations' commercial links (18 Aug 2010)

British Medical Journal Patients must reveal corporate sponsorship, urges campaign (16 Aug 2010)

HAI Europe's comment on the Agency's response:

The European Medicines Agency's transparency criteria do not state that financial information is to be disclosed to the Agency, nor is there an indication of any re-evaluation timeline. We look forward to working with the EMA to further clarify its re-evaluation process, as the data gathered in this research would suggest that EMA re-evaluations have not taken EMA's own transparency criteria into account.

We would also welcome the opportunity to work with EMA on definitions of “transparency”; currently an organisation is regarded as transparent if it submits data which is then held internally by the EMA, rather than in the public domain. The conclusions of the report are therefore based on the transparent and publicly disclosed information available online at the time of data collection, and on data requested directly from the groups themselves, which is in line with the EMA transparency guidelines. This is stated under Data sources in the research article, but HAI did not have access to data which the EMA keeps secret and to which they allude.

Impact of HAI Europe survey results: Two weeks on

2010-08-25T10:26:00.009+02:00

Two weeks after publishing HAI Europe's baseline survey of patient and consumer groups' financial disclosure, the findings and conclusions have been reported in media based in at least three European countries, including the British Medical Journal, the Dutch newspaper Trouw, Swedish 'Pharmaceutical World' gazette Lakemedels Varlden, and the international magazine SCRIP, among others.

Broadcast media in the Netherlands widely reported on the results. Dutch journalist Joop Bouma linked the survey results to the national situation in which some patient organisations in dialogue with the drug regulatory authority (CBG) are financed by the pharmaceutical industry. As a result, the Dutch Socialist Party has called for a thorough investigation of patient groups receiving corporate sponsorship and their compliance with the existing code of conduct.

We haven't recieved an official comment from the EMA to date, although their opinion on the survey conclusions is reported in various news articles. We hope to discuss the recommendations in the research article at the meeting of all patient and consumer organisations eligible to work with the EMA in November 2010.

HAI Europe survey reveals new data on financial transparency of patient and consumer organisations

2010-08-11T17:05:00.005+02:00

Two-thirds of the patient and consumer organisations working with the European Medicines Agency (EMA) received partial or significant funding from pharmaceutical manufacturers and/or industry associations, which suggests that the pharmaceutical industry is the prevalent sponsor of the patient voice at the EMA.

Fewer than half of the 23 organisations complied with EMA financial reporting guidelines. The EMA appears to have failed in the monitoring and enforcement its guidelines on financial transparency.

These and other main findings are reported in HAI Europe’s recent survey on levels of financial disclosure and transparency among patient and consumer organisations at the European Medicines Agency (EMA).

Read the Research Article and Factsheet on our website www.haieurope.org

Open Health Forum: more room for civil society?

2010-07-14T15:15:00.003+02:00

The Open Health Forum took place on July 29 to 30 in Brussels. Hosted by DG SANCO, the gathering aimed to convene the larger constituency of health actors to discuss European Health Policy.

In a different format than in previous years, the meeting kicked off with Commissioner John Dalli calling for an ideal future, where we would not face illness or problems in access to care in our everyday life, but live in a Europe where medical treatment would not be a priority because citizens would enjoy good health. In a world of increasing medicalisation, it was inspiring to hear his ideas.

But meanwhile, we are faced with the harsh reality of increasing health inequalities, great disparities between the EU-15 and the EU-27 countries, a lingering economic crisis, and a lack of political will and support for the introduction of health as a pivotal axis in overall policies. Rather than being considered as a limiting factor, or the big ‘black hole’ in national budgets, health should be seen as the key element to strive for to achieve sustainability. What would happen if economic, social, trade, work, transport and all policies would be shaped by or compliant with the interests of health? Undoubtedly, we would be better off.

The workshop on Innovation for Health had a strong representation from corporate interests in the panel (IT, Pharma, mining) in comparison with only one civil society delegate. The discussion that ensued revolved largely around how innovation played such an important role in health, but lagged behind in addressing real issues such as defining what innovation means, talking about access and affordability of innovation, or identifying key players in research and development beyond the “usual suspects”, i.e industry. HAI Europe intervened, to talk about the need to liaise the discussions on innovation for health with the council conclusions on the role of EU in global health.

What were we still missing at the end of the day?

In a nutshell more room to ask the so what questions: What is the role to be played by Civil Society in building and implementing future EU health policies and ensure citizens’ health and well-being?

Teresa Alves

Priorities of the Belgian Presidency

2010-06-29T11:28:00.008+02:00

Today at the EU Open Health Forum, Mr. Dirk Cuypers (Federal Public Service Health, Belgium) announced the health priorities on behalf of the Belgian Presidency, which will commence on July 1, 2010.

Health Security - two technical conferences: one on the flu pandemic and a second on the priorities for prevention and control of antimicrobial resistance

Health Systems - one meeting discussing health personnel across the EU and a conference to discuss innovative measures to prevent chronic conditions. Patients and their representatives will play an important role in the latter event.

Pharmaceuticals - one conference on September 23-24 on pharmaceutical innovation and solidarity, discussing how to measure and access innovation

Health Inequalities - two focus events: one on environmental health & social vulnerabilities, and a second on child poverty

Katrina Perehudoff

HAI Europe recommendations for improved conflict of interest declarations at EMA

2010-06-28T12:55:00.016+02:00

Following the growing debate about patient and expert interest disclosure at the European Medicines Agency (EMA), a discussion about conflict of interest declaration was high priority at the last Patients' and Consumers' Working Party (PCWP) meeting on June 16, 2010.

At the meeting, HAI Europe emphasized the importance of complete disclosure and the responsibility of the EMA to enforce its internal rules. The lack of compliance casts a shadow on the reputation, transparency and activities of both the PCWP and of the EMA.

HAI Europe suggested that the EMA these constructive steps:

Amend the declaration of interests form, where it now reads:

The organisation I am employed by receives a grant or other funding from a pharmaceutical company...
It should read:

The organisation that I represent, or that I am employed by, receives a grant or other funding from a pharmaceutical company...
Host an open tutorial session for all the EMA experts on completing the declaration of interest form. This meeting could also take place online;
Establish a calendar for renewal and completion of the declaration of interests form. Any expert who does not deliver an up-to-date form to the EMA should not be consulted. On the other hand, he/she should be prevented from actively engaging in EMA activities, until the situation is rectified.
Pro-actively ascertain the accuracy of patient and consumers expert statements in their declarations of interest, by cross-referencing those statements with the most recent financial report of the organization being represented.

Katrina Perehudoff

International Experts Find that Pending Anti-Counterfeiting Trade Agreement Threatens Public Interests

2010-06-24T10:29:00.005+02:00

June 23, 2010

American University Washington College of Law

Washington, D.C.

This statement reflects the conclusions reached at a meeting of over 90 academics, practitioners and public interest organizations from six continents gathered at American University Washington College of Law, June 16-18, 2010. The meeting, convened by American University's Program on Information Justice and Intellectual Property, was called to analyze the official text of the Anti-Counterfeiting Trade Agreement (ACTA), released for the first time in April, 2010. Negotiating parties released the text only after public criticism of the unusually closed process and widespread disquiet over the negotiations' presumed substance. (See Wellington Declaration, EU Resolution on Transparency and State of Play of the ACTA Negotiations).

We find that the terms of the publicly released draft of ACTA threaten numerous public interests, including every concern specifically disclaimed by negotiators.

Negotiators claim ACTA will not interfere with citizens' fundamental rights and liberties; it will.
They claim ACTA is consistent with the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS); it is not.
They claim ACTA will not increase border searches or interfere with cross-border transit of legitimate generic medicines; it will.
And they claim that ACTA does not require "graduated response" disconnections of people from the internet; however, the agreement strongly encourages such policies.

ACTA is the predictably deficient product of a deeply flawed process. What started as a relatively simple proposal to coordinate customs enforcement has transformed into a sweeping and complex new international intellectual property and internet regulation with grave consequences for the global economy and governments' ability to promote and protect the public interest.

Any agreement of this scope and consequence must be based on a broad and meaningful consultative process, in public, on the record and with open on-going access to proposed negotiating text and must reflect a full range of public interest concerns. As detailed below, this text fails to meet these standards.

Recognizing that the terms of the agreement are under further closed-door negotiation over a text we do not have access to, a fair reading of the April 2010 draft leads to our conclusion that ACTA is hostile to the public interest in at least seven critical areas of global public policy:fundamental rights and freedoms; internet governance; access to medicines; scope and nature of intellectual property law; international trade; international law and institutions; and democratic process.

The following specific comments are based on a review of the publicly released text which is highly bracketed and the conclusions are therefore tentative.

FUNDAMENTAL RIGHTS AND FREEDOMS

ACTA would authorize or encourage private and government enforcement measures that would:

curtail enjoyment of fundamental rights and liberties, including domestic and internationally protected human rights to health, privacy and the protection of personal data, free expression, education, cultural participation, and right to a fair legal process, including fair trial and presumptions of innocence.

THE INTERNET

ACTA would

Encourage internet service providers to police the activities of internet users by holding internet providers responsible for the actions of subscribers, conditioning safe harbors on adopting policing policies, and by requiring parties to encourage cooperation between service providers and rights holders;
Encourage this surveillance, and the potential for punitive disconnections by private actors, without adequate court oversight or due process;
Globalize 'anti-circumvention' provisions which threaten innovation, competition, free (freedom-respecting) software, open access business models, interoperability, the enjoyment of user rights, and user choice;

ACCESS TO MEDICINES

ACTA would threaten global access to affordable medicines, including by:

Authorizing customs authorities to seize goods in transit countries, even when they do not infringe any laws of the producing or importing countries;
Implicating non-infringing active pharmaceutical ingredient suppliers whose materials may be used downstream in infringing products without their knowledge;
Limiting key flexibilities on injunctions, including in patent cases, that are necessary for government use, for court-ordered royalties, and for innovation prizes and other policies that de-link cost of research and development from the price of products.
Expanding its scope to patents in many areas of the agreement, which is an inappropriate subject of a counterfeiting policy;

SCOPE AND NATURE OF INTELLECTUAL PROPERTY LAW

ACTA would distort fundamental balances between the rights and interests of proprietors and users, including by

introducing highly specific rights and remedies for rights holders without detailing correlative exceptions, limitations, and procedural safeguards for users;
shifting enforcement burdens to public authorities and private intermediaries in ways that are likely to be more sensitive to proprietary concerns;
requiring formula-driven assessment of damages, potentially unrelated to any proven harm or gain;
omitting strong disincentives to abuse of enforcement processes by right holders;
including rigid injunction, damages and heightened civil and criminal enforcement requirements that will restrict government flexibility, impede innovation and slow the development and diffusion of green technology;
threaten the continuation or development of innovative public intererst exceptions, such as common law approaches to permitting copies of works by "authorization."

INTERNATIONAL TRADE

ACTA would raise barriers to the trade in knowledge imbedded goods, disproportionately harming developing countries dependent on imports and exports of essential goods. Specifically, ACTA will

Extend ‘ex officio' and in transit border search and seizures to a broad range of "suspected" intellectual property infringements, even including alleged patent infringements involving complex questions of law and fact that are impossible to judge by custom authorities.

INTERNATIONAL LAW AND INSTITUTIONS

ACTA would conflict with a large number of existing international laws and processes. Specifically, ACTA contains provisions that:

Conflict with the World Trade Organization Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) by allowing seizures based on the law "of the party providing the procedures" instead of "the country of importation" (TRIPS Art. 52) and by failing to fully protect and incorporate key protections against abuse (e.g. Articles 41.1, 48.1, 48.2, 50.3, 53.1, 56), flexibilities to promote public interests (e.g. TRIPS Art. 44.2), requirements for the proportionality of enforcement measures (e.g. Arts. 46, 47), and provisions providing for balance between the interests of proprietors, consumers and the greater society (e.g. TRIPS Arts. 1, 7, 8, 40, 41.2, 41.5, 54, 55, 58).
Conflict with the WTO Doha Declaration on TRIPS and Public Health and World Health Assembly Resolution 61.21 by limiting the ability of countries to use the TRIPS flexibilities "to the full" to promote access to medicines;
Undermine the World Intellectual Property Organization (WIPO) Development Agenda, particularly recommendation 45's commitment to "approach intellectual property enforcement in the context of broader societal interests and especially development-oriented concerns";
Undermine the roles of WIPO and WTO by creating a new and redundant international administration.

DEMOCRATIC PROCESS

ACTA alters traditional and constitutionally mandated law making processes by:

Exporting and locking in controversial and problematic enforcement practices, foreclosing future legislative improvements in response to changes in technology or policy;

Requiring substantive changes to laws of many countries without legislative process;

The process of ACTA's negotiation is fundamentally flawed. Specifically, the negotiations:

Have not been conducted in public as are many multilateral negotiations;
Have not been accompanied by evidence demonstrating the public policy problems sought to be addressed;
Have proceeded under conditions that restrict public input to select stakeholders, held off-the-record and without access to the latest version of the rapidly changing text;
Lack a balanced representation of stakeholders, especially from civil society.

Detailed explanation of issues in declaration

ACTA section by section analysis

SIGNATURES: http://www.wcl.american.edu/pijip/go/acta-communique

ISDB & MiEF criticize EMA over conflict of interest procedures

2010-06-23T12:57:00.010+02:00

In an open letter from the International Society of Drug Bulletins (ISDB) and the Medicines in Europe Forum (MiEF) to the EMA's executive director, Thomas Lonngren, the Agency is criticized for failing to monitor and implement its conflict of interest procedures for board members.

These accussations stem from CEO's earlier report on incomplete declarations of interest made by patient representatives at the Agency.

ISDB & MiEF raise key shortcomings of the EMA conflict of interest procedures:

EMA experts are not required to declare the interests of their households, while this is information commonly requested on conflict of interest forms at national drug agencies;

EMA experts are only asked to declare financial interests in pharmaceutical companies if they exceed 50,000 euros;

More than 1 in 4 EMA experts have a 'high risk level' of conflict of interest, particularly with respect to product-specific decisions.

Continue reading the open letter...

The Agency's response to the open letter, covered in the BMJ article 'European drug regulator is criticized over patient representatives' conflicts of interest', mentioned that an updated conflict of interest policy was agreed at an Agency meeting on 10 June 2010 and is due to be adopted in October.

Katrina Perehudoff

Innovation & Access at the EU High Level Event on Global Health

2010-06-14T17:37:00.005+02:00

On the 10th and 11th of June, the Global Health Conference took place in Brussels, stemming from the Global Health Communication and Council Conclusions on Global Health, which were driven by the Spanish Presidency. For many, this new EU policy on global health represents a breakthrough as the EU takes an unprecedented stance on global health issues, setting clear priorities that are not necessarily aligned with the EU's earlier position on, for example, innovation and access issues.

Speakers included Commissioner John Dalli of DG SANCO, Margaret Chan- WHO Director General, Paola Testori Coggi -the Director General of DG SANCO and David Chiriboga- the Minister of Health of Ecuador and president of UNASUR (political union of South American countries).

Buen vivir

It was excellent that the Minister of Health of Ecuador had been invited as keynote speaker, who presented a new political approach to many of the issues. UNASUR has placed health firmly on its agenda and taken forward a regional approach to improve its population's health. The concept of 'Buen vivir' or living well, wellbeing, guides their development perspective, in contrast with the dominant perspective on development that forwards the primacy of the economic dimension focused mainly on growth.

Innovation & access theme

Access to Medicines and Innovation are now firmly on the agenda of the Global Health policy of the European Union. The Director of Health in DG Research, Dr Roxandra Draghia-Akli noted in her opening speech that innovation must be acceptable, affordable and accessible. Innovation alone is not enough to achieve health and, to that end, public intervention in neccessary. Both Dr Draghhi and and Dr. Margret Chan noted that there is a need to explore models that dissociate the costs of R&D from the prices of medicines, which is also stated in the recent Council Conclusions on Global Health.

The conference included a workshop on innovation and access, with presentations by William Aldis, Tido von Schoen Angerer of MSF, Melinda Moree from Bioventures for Health and Francios Bompart, representative of Sanofi Aventis, Jorge Bermudez of UNITAID and Charles Mgone of EDCTP. Topics to be adressed included 1) Assess the opportunities for the EU to foster innovation in health 2) Funding and policy instruments available and 3) The implementation of Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property.

There were discussions on the IP agenda of the EU and the declining policy space for countries to provide access to medicines. In this regard, the problems with the surge of anti-counterfeiting legislation representing an IP enforcement agenda were named, which further frustrates the policy space developing countries have to secure access to medicines. Related to this issue, the need to focus on substandard medicines and regulatory capacity strengthening was emphasized. MSF presented on the need for new models of innovation and the delinkage principle, indicating various proposals, like a prize for TB diagnostics. There was a discussion on PDPs, their achievements and weaknesses, and the need for country ownership and capacity buillding.

Although the presentations were very focused and gave clear pointers for concrete recommendations, the chair Robert Ridley did not manage to really move the discussion beyond conclusions that had been already reached as a basis for the discussions in the IGWG at the WHO. However in the plenary session on Friday, the recommendations turned out quite concrete, with the 5 themes being:

Take a holistic, coherent and inclusive approach to health research
Ensure country ownership and support of health and research systems
Identify new financing mechanims and incentives for innovation and acess >>Including delinkage and push and pull mechanism, PDPs, Prizes and creating a market.
Capacity needs should be strongly recoginised
Link innovation and access >> consider acccess issues from the start, broad perspecive of innovation, which includes access to healthcare and social innovation.

Other thematic priorities

Other working groups were: 'global health for all', 'coherence in response to globalisation challenge', 'health as a human right' and 'research: local and global challenges'

Recommendations included:

Leadership and governance at global WHO/WHA level, strengthening WHO's leadership roles and governance, strenthening the WHO's normative role.
Policy coherence regarding trade and migrations
Strengthening of comprehenisve health systems in partner countres applying the aid effectiveness principles.

An important aspect that transpired from concurrent session was the importance of building capacity in the South, through institutional cooperantion rather than through vertical projects and approaches. It was noted that the EU and the US as key donors and key players in international health, often tend to impose their own agendas, rather than seek to adapt and to adopt the agendas of the Southern partners. By doing so, they were contributing to disharmonisation of health priorities.

Moving forward

Although the recommendations reached barely go beyond the Communication and Council Conclusions, this conference was important for the high level political appropriation of the policy. Now, what is really needed is to go into the concrete aspects, to have working groups, and to look at the implicatons for funding. Basically, these policy priorities now need to be translated into action. What will the EU specifically do? A first step seems to be to form working groups around these specific recommendations.

Review of conflict of interest policies in three European medicines regulation agencies

2010-06-14T15:50:00.007+02:00

HAI Europe members Dr. Orla O'Donovan and Dr. Joel Lexchin published the article 'Prohibiting or 'managing' conflicts of interest (COI)? A review of policies and procedures in three European medicines regulation agencies' in Social Science & Medicine (2010).

The authors conclude that drug regulatory agencies, including the European Medicine Agency,

"...presuppose and promote the ideas that COIs cannot and need not be eliminated as the risk of bias can be managed. ...Given that much available evidence implies that commercial interests bias regulatory science, we advocate an alternative normative approach based on the precautionary principle." Continue reading article...

Conflicts of interest among drug regulators could potentially have harmful health consequences. Under the precautionary principle, such conflicts should be prohibited as they might negatively influence the outcome of regulatory decisions.

This policy review, coupled with the recent discovery of misleading and/or incomplete Declaration of Interest statements made by corporate-sponsored patient organisations sitting on European Medicines Agency committees, highlights the immanent need for a rigorous review and exclusion of conflicts of interest within the Agency.

Katrina Perehudoff

Medicines manufacturers have clear motives for financing the patient voice

2010-06-08T16:41:00.007+02:00

Industry magazine SCRIP ran an article titled "Patient representation and advocacy in the EU" describing the evolving role of European patient groups as political players and industry partners.

The author concluded that pharmaceutical industry support is not a concealed marketing ploy aimed at influencing patient choice. Instead, companies have clear motives to support advocacy groups' efforts with much-needed resources.

HAI Europe's rapid response:

Finite public funds means that some patient groups, lacking sufficient resources, accept additional support from pharmaceutical companies.
This article omits the benefits that companies stand to gain from such relationships. Industry literature links corporate-funded patient advocates with enhanced compliance and customer loyalty, expanded prescribing and sales, and reduced regulatory barriers.
Medicines manufacturers have clear motives for financing the patient voice: it just makes good cents.

Quito Declaration

2010-06-03T15:00:00.003+02:00

IV Meeting of Latin America & Caribbean – Global Alliance for Access to Medicines

DECLARATION

Quito, Ecuador 22 - 24 April 2010

Organizations of the Latin American and Caribbean (LAC) - Global Alliance for Access to Medicines reaffirm their commitment to work to ensure universal access to medicines, in the belief that medicines are enabling factors for the full exercise of the right to life. The LAC –Global Alliance has identified old and new policies and processes, some of which enable access to medicines, while others sustain commercial privileges that become obstacles to the achievement of public interest outcomes. Access to medicines should not be subordinated to commercial interests.

The LAC-Global Alliance welcomes and supports the new initiatives of the governments of Ecuador and Colombia which are aimed at promoting competition and regulating the pharmaceutical market, as effective means to reduce medicine prices. The Ecuadorian government has issued a compulsory license for lopinavir-ritonavir (Kaletra), a medicine for the treatment of HIV that was previously sold under monopoly. The compulsory license offers significant savings that make it possible to expand treatment coverage and use capacity to attend to other health priorities. The Colombian government has issued Decree 1313, which authorizes parallel imports to overcome the high medicine prices being imposed by pharmaceutical companies. Both initiatives are legitimate and the sovereign application of flexibilities enshrined in the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). They should be regarded as examples for countries of the region to follow, in order to improve access to medicines in accordance with governments' efforts to achieve the Millennium Development Goals.
The LAC-Global Alliance rejects attempts to enact the so-called Anti Counterfeiting Trade Agreement (ACTA) , which, led by the governments of the United States, Japan, Switzerland and the EU, aims to set new global norms using a biased and malicious interpretation of the concept of counterfeiting. Implementation of ACTA would limit the production and free movement of legitimate generic products. This new agreement has been negotiated in secret since 2008, and only under the pressure of civil society organizations did the parties recently make the draft agreement public. ACTA presents a serious threat to access to medicines that could exceed even the current restrictions countries face under TRIPS and bilateral Free Trade Agreements (FTA’s). This agreement is being negotiated without the participation of countries in the region, even though they will inevitably affect them.
The LAC–Global Alliance expresses grave concern about ,and rejects the advancement of, trade agreements that include TRIPS-plus and TRIPS-extra provisions, including trade agreements with the United States and the European Union (EU). The Alliance also rejects pressures related to implementation of these agreements which are intended to impose greater restrictions on national laws and regulations. The Alliance is particularly concerned with the initiation of negotiations on the Trans Pacific Partnership Agreement (TPPA) as well as the EU negotiations with Central American countries. Both risk negative effects on public health and patients’ rights. The LAC-Global Alliance calls on governments, civil society and private companies in Central American countries to be alert to avoid the imposition of new provisions for intellectual property protection such as patent extensions, longer periods of data exclusivity, and enforcement measures, that could affect public health and access to medicines. Similarly, the LAC-Global Alliance calls on all governments in the LAC region not to accept any imposition on their national legislation that could further damage the public interest, particularly the right to health.
The failures of the Expert Working Group on Research and Development Financing established by the World Health Organization (WHO) are evident and unfortunate. This is a step backwards in implementing The Global Strategy and Plan of Action on Public Health Innovation and Intellectual Property. We are disappointed and dismayed with the way that WHO has handled this issue. The LAC-Global Alliance is convinced that mechanisms to encourage innovation that de-link the cost of research and development (R&D) from the final price of products should be explored. Monopoly incentives cannot meet the needs for R&D of medicines, particularly for diseases that primarily affect developing countries. Therefore, we call on civil society organizations and governments to engage in a process aimed at setting international norms and standards for innovation, based on the health needs of the majority of the world's population, including hitherto neglected diseases, to reach a global treaty on biomedical research and development. This should be put on the table for discussion at multilateral agencies such as WHO.
The LAC-Global Alliance calls on public and private agencies in countries of the region and multilateral agencies to develop initiatives to measure the impact of intellectual property protection on access to medicines, whether this impact is a result of the TRIPS Agreement, or of bilateral / regional and national laws arising from TRIPS, including the protection of clinical trial data. In particular we call upon the governments of the region to improve their procedures on patenting and protection of clinical trial data, in order to avoid granting undue exclusivity. Moreover, we encourage governments to explore initiatives to avoid any monopoly over medicines that are included in their essential medicines list or formularies.
The LAC-Global Alliance welcomes regional and sub-regional initiatives that seek new ways to protect, promote and defend the right to health. These should include innovative solutions that commit countries to put their pharmaceutical production and innovation capacity to work for the needs of regional populations, and provide real impetus to a true pro-innovation and development agenda, founded on and responsive to regional needs.
The Alliance notes that in the case of biotechnological health products, there is pressure on our governments to increase exclusivity and monopoly protection, with controversial regulatory requirements and the extension of intellectual property and data protection regimes that will limit market entry of competing medicines. We recommend governments approach any regulatory or intellectual property-related decisions on this matter with the utmost seriousness and independence, including through the participation of civil society to represent the interests of public health.
The LAC-Global Alliance urges governments of the region and political forces in its countries to remain vigilant toward attempts to establish new mechanisms that impede access to medicines. At the same time, the LAC-Global Alliance hereby offers its assistance and puts its technical knowledge at the service of relevant stakeholders toward developing initiatives that contribute to improving the health of populations.

Quito, Ecuador 22 - 24 April 2010

Acción Internacional por la Salud (HAI) Latin America and the Caribbean

Acción Internacional por la Salud (HAI) Bolivia

Acción Internacional por la Salud (HAI) Ecuador

Acción Internacional por la Salud (HAI) Peru

Federación Médica de Colombia - OBSERVAMED

FarmaMundi - Spain

IFARMA Foundation - Colombia

Health Action International (HAI) Europe

Knowledge Ecology International (KEI), United States

Mision Salud, Colombia

Medicines Sans Frontieres(MSF)-Brazil

Public Citizen, United States

Peruvian Network for Fair Globalisation – RedGE

Red Brasilera por la Integración de los Pueblos – REBRIP Brasil

Independent drug bulletin and assessment reports from Spain - now in English

2010-06-01T10:13:00.015+02:00

Since 1993, doctors and pharmacists in Spain have digested the latest findings into a balanced review of current treatments for common diseases: The Drug and Therapeutics Bulletin of Navarre. It is available free online at DBT-Navarre in Spanish and English (since 2007). The latest Drug Assessment Reports are a recently added feature.

DBT-Navarre was featured at a HAI Europe 2009 workshop on Independent Medicines Information in Lisbon, Portugal. The presentation How to set-up an independent drug bulletin? by Dr. Juan Erviti profiles the birth of DBT-Navarre as a case study. His presentation is available to download in Portuguese and English.

Katrina Perehudoff

Quito Declaration

2010-05-23T11:12:00.007+02:00

DECLARATION

Quito, Ecuador 22 - 24 April 2010

1. The LAC-Global Alliance welcomes and supports the new initiatives of the governments of Ecuador and Colombia which are aimed at promoting competition and regulating the pharmaceutical market, as effective means to reduce medicine prices. The Ecuadorian government has issued a compulsory license for lopinavir-ritonavir (Kaletra), a medicine for the treatment of HIV that was previously sold under monopoly. The compulsory license offers significant savings that make it possible to expand treatment coverage and use capacity to attend to other health priorities. The Colombian government has issued Decree 1313, which authorizes parallel imports to overcome the high medicine prices being imposed by pharmaceutical companies. Both initiatives are legitimate and the sovereign application of flexibilities enshrined in the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). They should be regarded as examples for countries of the region to follow, in order to improve access to medicines in accordance with governments' efforts to achieve the Millennium Development Goals.

2. The LAC-Global Alliance rejects attempts to enact the so-called Anti Counterfeiting Trade Agreement (ACTA) , which, led by the governments of the United States, Japan, Switzerland and the EU, aims to set new global norms using a biased and malicious interpretation of the concept of counterfeiting. Implementation of ACTA would limit the production and free movement of legitimate generic products. This new agreement has been negotiated in secret since 2008, and only under the pressure of civil society organizations did the parties recently make the draft agreement public. ACTA presents a serious threat to access to medicines that could exceed even the current restrictions countries face under TRIPS and bilateral Free Trade Agreements (FTA’s). This agreement is being negotiated without the participation of countries in the region, even though they will inevitably affect them.

3. The LAC–Global Alliance expresses grave concern about ,and rejects the advancement of, trade agreements that include TRIPS-plus and TRIPS-extra provisions, including trade agreements with the United States and the European Union (EU). The Alliance also rejects pressures related to implementation of these agreements which are intended to impose greater restrictions on national laws and regulations. The Alliance is particularly concerned with the initiation of negotiations on the Trans Pacific Partnership Agreement (TPPA) as well as the EU negotiations with Central American countries. Both risk negative effects on public health and patients’ rights. The LAC-Global Alliance calls on governments, civil society and private companies in Central American countries to be alert to avoid the imposition of new provisions for intellectual property protection such as patent extensions, longer periods of data exclusivity, and enforcement measures, that could affect public health and access to medicines. Similarly, the LAC-Global Alliance calls on all governments in the LAC region not to accept any imposition on their national legislation that could further damage the public interest, particularly the right to health.

4. The failures of the Expert Working Group on Research and Development Financing established by the World Health Organization (WHO) are evident and unfortunate. This is a step backwards in implementing The Global Strategy and Plan of Action on Public Health Innovation and Intellectual Property. We are disappointed and dismayed with the way that WHO has handled this issue. The LAC-Global Alliance is convinced that mechanisms to encourage innovation that de-link the cost of research and development (R&D) from the final price of products should be explored. Monopoly incentives cannot meet the needs for R&D of medicines, particularly for diseases that primarily affect developing countries. Therefore, we call on civil society organizations and governments to engage in a process aimed at setting international norms and standards for innovation, based on the health needs of the majority of the world's population, including hitherto neglected diseases, to reach a global treaty on biomedical research and development. This should be put on the table for discussion at multilateral agencies such as WHO.

5. The LAC-Global Alliance calls on public and private agencies in countries of the region and multilateral agencies to develop initiatives to measure the impact of intellectual property protection on access to medicines, whether this impact is a result of the TRIPS Agreement, or of bilateral / regional and national laws arising from TRIPS, including the protection of clinical trial data. In particular we call upon the governments of the region to improve their procedures on patenting and protection of clinical trial data, in order to avoid granting undue exclusivity. Moreover, we encourage governments to explore initiatives to avoid any monopoly over medicines that are included in their essential medicines list or formularies.

6. The LAC-Global Alliance welcomes regional and sub-regional initiatives that seek new ways to protect, promote and defend the right to health. These should include innovative solutions that commit countries to put their pharmaceutical production and innovation capacity to work for the needs of regional populations, and provide real impetus to a true pro-innovation and development agenda, founded on and responsive to regional needs.

7. The Alliance notes that in the case of biotechnological health products, there is pressure on our governments to increase exclusivity and monopoly protection, with controversial regulatory requirements and the extension of intellectual property and data protection regimes that will limit market entry of competing medicines. We recommend governments approach any regulatory or intellectual property-related decisions on this matter with the utmost seriousness and independence, including through the participation of civil society to represent the interests of public health.

The LAC-Global Alliance urges governments of the region and political forces in its countries to remain vigilant toward attempts to establish new mechanisms that impede access to medicines. At the same time, the LAC-Global Alliance hereby offers its assistance and puts its technical knowledge at the service of relevant stakeholders toward developing initiatives that contribute to improving the health of populations.

Quito, Ecuador 22 - 24 April 2010

Acción Internacional por la Salud (HAI) Latin America and the Caribbean

Acción Internacional por la Salud (HAI) Bolivia

Acción Internacional por la Salud (HAI) Ecuador

Acción Internacional por la Salud (HAI) Peru

Federación Médica de Colombia - OBSERVAMED

FarmaMundi - Spain

IFARMA Foundation - Colombia

Health Action International (HAI) Europe

Knowledge Ecology International (KEI), United States

Mision Salud, Colombia

Medicines Sans Frontieres(MSF)-Brazil

Public Citizen, United States

Peruvian Network for Fair Globalisation-RedGE

Red Brasilera por la Integración de los Pueblos-REBRIP Brasil