Priorities of the Belgian Presidency

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

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

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

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

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:

1. Take a holistic, coherent and inclusive approach to health research
2. Ensure country ownership and support of health and research systems
3. Identify new financing mechanims and incentives for innovation and acess >>Including delinkage and push and pull mechanism, PDPs, Prizes and creating a market.
4. Capacity needs should be strongly recoginised
5. 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

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

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

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.

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.
8. 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

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