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
Thursday, June 30, 2011
Thursday, June 23, 2011
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
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
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
"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
Wednesday, June 22, 2011
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
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
Tuesday, June 21, 2011
Submission to the Consultative Expert Working Group (CEWG) on alternative financing
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.
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.
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