Final Report Summary - INNOVA-P2 (Pharma-innovation - patent-2)
INNOVA-P2 addressed the problematic that is evident in the current international intellectual property regime with regard to the pharmaceutical sector: developing new drugs requires monopoly protection to help inventors recuperate their investments, but the same protection system is becoming a major obstacle preventing less well-off (i.e. the global majority) patients from accessing new medicines.
The project explored alternatives to the current system in deliberations with a host of international experts from academia, policymaking, pharma and non-governmental organisation (NGO) communities. The project consortium involved experts in political science, policymaking, philosophy, economics, law, natural science, medicine, bioethics, development, psychology, gender studies and anthropology. The partners were either attached to academic research institutions (UCLAN, CAPPE, UPM, WU, FAFO) or to related ministries in developing countries (Casted, RIS).
INNOVA-P2 undertook an exhaustive analysis of existing intellectual property rights (IPR) reform plans regardless of their main reward mechanism (i.e. 'push' mechanisms that select and fund some particular innovator, or 'pull' mechanisms that promise to reward whoever is the first to achieve a valued innovation). The most promising strategy that avoids the pitfalls of the main push and pull programs while addressing the 'last-mile' problem (i.e. ways to reach patients in difficult circumstances), was found to be the Health Impact Fund (HIF). HIF is proposed as a publicly-funded initiative whereby inventor firms would be entitled to take out a multi-year patent on any essential medicines they invent, during the life of which, they will be rewarded in proportion to the impact of their invention on the global disease burden. The scheme promotes innovation in the sector while allowing for enhanced access to medicines by less-well-off people. Firms have incentives to sell innovative treatments cheaply in order to enhance profits within the scheme; they also have incentives to prioritise prevention over treatment and to ensure that patients are fully instructed in the proper use of drugs.
A Delphi study with key stakeholders in the sector (developed and developing country health policymakers, NGOs, pharma industry, health economists, etc.) showed that HIF is perceived as a plausible solution to the main issues while being viewed as feasible and reliable. The main pitfall of the scheme was considered to be the strong political will required to fund it. In view of this, INNOVA-P2 undertook a reality-check for HIF involving the two most powerful developing country actors (India and China) and forged a consensus for the new system by providing a policy action plan. Policymakers from China and India agreed with the principle of HIF and showed that it can be applied regionally via bilateral initiatives that cover the immense local needs in access to medicines. A concrete plan of action was developed and presented in the policymaking communities of the two nations that involved the creation of the scheme with a focus, at first instance, in the area of traditional medicines. At the same time, developed country policymakers took part in the deliberations and showed interest in including the HIF scheme in their developing programme strategies in the health sector.
Amending the current system represents one of the major 21st century challenges, namely delivering reasonably priced health care to patients around the world. INNOVA-P2 attempts to explore alternatives to the current system by involving in its deliberations a host of international experts from academia, policymaking, pharma and NGO communities.
The project has fully achieved its objectives. In terms of each objective:
Advance knowledge and ethical insight into reform plans for the current IPR system
This objective was addressed in the first period through group discussions in two plenary meetings (Oslo, 26-27 August 2008 and Beijing, 27-28 August 2009) and the production of three reports on 'IPR reform plans', 'Prudential reasons for P2' and 'Ethical reasons for P2'. The reports provide additional insights that deliver a clear verdict on the necessity for IPR reform plans and the choice of the HIF as the most promising candidate. In the second period, this objective has been fully achieved through group discussions in two further plenary meetings (Melbourne, 24-25 March 2010 and New Delhi, 12-13 May 2011) and the production of a special section on 'IPR reforms' in the Cambridge Quarterly of Healthcare Ethics, Volume 20, Number 2, Spring 2011. These papers provide additional insights from invited experts that deliver a clear verdict on the necessity for IPR reform plans and the choice of the HIF as the most promising candidate.
Finalise the existing plan to amend the current IPR system in the area of pharmaceutical innovation
This objective developed significantly in the first period through group discussions and two reports on 'Metrics and distribution mechanisms' and 'Protective mechanisms'. The reports considerably advance the function of the reform plan by distinguishing areas that need particular attention and suggesting solutions. In the second period, this objective has been developed significantly through group discussions and the production of a publication in the Chinese journal: Forum on science and technology, 2011. The reports considerably advance the function of the reform plan by distinguishing areas that need particular attention and suggesting regional solutions. With the results of the Delphi study ('Outcome of foresight analysis'), the group has all the information needed to achieve this objective at global level and offer a finalised version of the reform plan. The additional project work on impact assessment and gender issues has completed this part of the project work.
Provide a reality check and obtain support for the new system from the world's two most powerful developing / emerging country actors (India and China)
This objective was developed significantly in the first period through bilateral discussions between India and China organised as part of the project process. The discussion provided important feedback on the reform plan from the policymaking communities in the two countries, and resulted in tentative agreement that the area of traditional medicine was an excellent candidate for a regional application of the HIF involving both countries. More detailed discussions were planned in the next year to work out details of this agreement. This objective has therefore been developed significantly through bilateral discussions between India and China organised as part of the project process in the second period, resulting in the production of a report on the 'Alignment of INNOVA-P2 goals with related Indian and Chinese WTO-work'. The discussion has provided important feedback on the reform plan from the policymaking communities in the two countries, and has also resulted in agreement that a regional application of the HIF involving both countries is both desirable and feasible in areas of common interest (e.g. traditional medicines). The final project conference in New Delhi (12-13 May 2011) provided the chance to promote this collaboration and involve directly the policymaking communities of the two countries. The proceedings of this conference will be published in the form of a Cambridge University Press book in the near future.
Promote urgent policy developments on IPR by forging a consensus for the new system and providing a policy action plan
This objective was partially achieved in the first period by the dialogue instigated between the policymaking communities in India and China. In the second period, the dialogue instigated between the policymaking communities in India and China has resulted in concrete action plans: a policy consensus document has been developed by the two project partners, 'Common policy grounds between India and China on HIF', which forms the basis of the final policy roadmap to be adopted in the first instance bilaterally and eventually at the global level. The two policy focused meetings at:
1) the European Parliament (11 April 2011), with the participation of the European Union (EU) Commissioner for Development, Dr Andris Piebalgs; and
2) New Delhi (12-13 May 2011), with the participation of the former president of India, HE Dr APJ Abdul Kalam, have been pivotal in promoting consensus for the new system.
INNOVA-P2 activities had significant impact on international debates and policymaking during the lifetime of the project and more importantly, produced a policy action blueprint that is taken up in Europe as well as China and India.
The reports on ethical argumentation as well as impact assessment were discussed with policymakers from India and China (during the first period bilateral meetings) as well as with officials from the World Health Organization (WHO), medical foundations and NGOs (at the first main dissemination event in Melbourne, March 2010). As a result, the HIF was further discussed as a blueprint for bilateral action between India and China, it was included in the WHO debates on ways to increase access to medicines globally and it was also included in discussions between the German foundation Friedrich Ebert Stiftung (FES) and the Global Fund to Fight AIDS, Tuberculosis and Malaria.
The project explored alternatives to the current system in deliberations with a host of international experts from academia, policymaking, pharma and non-governmental organisation (NGO) communities. The project consortium involved experts in political science, policymaking, philosophy, economics, law, natural science, medicine, bioethics, development, psychology, gender studies and anthropology. The partners were either attached to academic research institutions (UCLAN, CAPPE, UPM, WU, FAFO) or to related ministries in developing countries (Casted, RIS).
INNOVA-P2 undertook an exhaustive analysis of existing intellectual property rights (IPR) reform plans regardless of their main reward mechanism (i.e. 'push' mechanisms that select and fund some particular innovator, or 'pull' mechanisms that promise to reward whoever is the first to achieve a valued innovation). The most promising strategy that avoids the pitfalls of the main push and pull programs while addressing the 'last-mile' problem (i.e. ways to reach patients in difficult circumstances), was found to be the Health Impact Fund (HIF). HIF is proposed as a publicly-funded initiative whereby inventor firms would be entitled to take out a multi-year patent on any essential medicines they invent, during the life of which, they will be rewarded in proportion to the impact of their invention on the global disease burden. The scheme promotes innovation in the sector while allowing for enhanced access to medicines by less-well-off people. Firms have incentives to sell innovative treatments cheaply in order to enhance profits within the scheme; they also have incentives to prioritise prevention over treatment and to ensure that patients are fully instructed in the proper use of drugs.
A Delphi study with key stakeholders in the sector (developed and developing country health policymakers, NGOs, pharma industry, health economists, etc.) showed that HIF is perceived as a plausible solution to the main issues while being viewed as feasible and reliable. The main pitfall of the scheme was considered to be the strong political will required to fund it. In view of this, INNOVA-P2 undertook a reality-check for HIF involving the two most powerful developing country actors (India and China) and forged a consensus for the new system by providing a policy action plan. Policymakers from China and India agreed with the principle of HIF and showed that it can be applied regionally via bilateral initiatives that cover the immense local needs in access to medicines. A concrete plan of action was developed and presented in the policymaking communities of the two nations that involved the creation of the scheme with a focus, at first instance, in the area of traditional medicines. At the same time, developed country policymakers took part in the deliberations and showed interest in including the HIF scheme in their developing programme strategies in the health sector.
Amending the current system represents one of the major 21st century challenges, namely delivering reasonably priced health care to patients around the world. INNOVA-P2 attempts to explore alternatives to the current system by involving in its deliberations a host of international experts from academia, policymaking, pharma and NGO communities.
The project has fully achieved its objectives. In terms of each objective:
Advance knowledge and ethical insight into reform plans for the current IPR system
This objective was addressed in the first period through group discussions in two plenary meetings (Oslo, 26-27 August 2008 and Beijing, 27-28 August 2009) and the production of three reports on 'IPR reform plans', 'Prudential reasons for P2' and 'Ethical reasons for P2'. The reports provide additional insights that deliver a clear verdict on the necessity for IPR reform plans and the choice of the HIF as the most promising candidate. In the second period, this objective has been fully achieved through group discussions in two further plenary meetings (Melbourne, 24-25 March 2010 and New Delhi, 12-13 May 2011) and the production of a special section on 'IPR reforms' in the Cambridge Quarterly of Healthcare Ethics, Volume 20, Number 2, Spring 2011. These papers provide additional insights from invited experts that deliver a clear verdict on the necessity for IPR reform plans and the choice of the HIF as the most promising candidate.
Finalise the existing plan to amend the current IPR system in the area of pharmaceutical innovation
This objective developed significantly in the first period through group discussions and two reports on 'Metrics and distribution mechanisms' and 'Protective mechanisms'. The reports considerably advance the function of the reform plan by distinguishing areas that need particular attention and suggesting solutions. In the second period, this objective has been developed significantly through group discussions and the production of a publication in the Chinese journal: Forum on science and technology, 2011. The reports considerably advance the function of the reform plan by distinguishing areas that need particular attention and suggesting regional solutions. With the results of the Delphi study ('Outcome of foresight analysis'), the group has all the information needed to achieve this objective at global level and offer a finalised version of the reform plan. The additional project work on impact assessment and gender issues has completed this part of the project work.
Provide a reality check and obtain support for the new system from the world's two most powerful developing / emerging country actors (India and China)
This objective was developed significantly in the first period through bilateral discussions between India and China organised as part of the project process. The discussion provided important feedback on the reform plan from the policymaking communities in the two countries, and resulted in tentative agreement that the area of traditional medicine was an excellent candidate for a regional application of the HIF involving both countries. More detailed discussions were planned in the next year to work out details of this agreement. This objective has therefore been developed significantly through bilateral discussions between India and China organised as part of the project process in the second period, resulting in the production of a report on the 'Alignment of INNOVA-P2 goals with related Indian and Chinese WTO-work'. The discussion has provided important feedback on the reform plan from the policymaking communities in the two countries, and has also resulted in agreement that a regional application of the HIF involving both countries is both desirable and feasible in areas of common interest (e.g. traditional medicines). The final project conference in New Delhi (12-13 May 2011) provided the chance to promote this collaboration and involve directly the policymaking communities of the two countries. The proceedings of this conference will be published in the form of a Cambridge University Press book in the near future.
Promote urgent policy developments on IPR by forging a consensus for the new system and providing a policy action plan
This objective was partially achieved in the first period by the dialogue instigated between the policymaking communities in India and China. In the second period, the dialogue instigated between the policymaking communities in India and China has resulted in concrete action plans: a policy consensus document has been developed by the two project partners, 'Common policy grounds between India and China on HIF', which forms the basis of the final policy roadmap to be adopted in the first instance bilaterally and eventually at the global level. The two policy focused meetings at:
1) the European Parliament (11 April 2011), with the participation of the European Union (EU) Commissioner for Development, Dr Andris Piebalgs; and
2) New Delhi (12-13 May 2011), with the participation of the former president of India, HE Dr APJ Abdul Kalam, have been pivotal in promoting consensus for the new system.
INNOVA-P2 activities had significant impact on international debates and policymaking during the lifetime of the project and more importantly, produced a policy action blueprint that is taken up in Europe as well as China and India.
The reports on ethical argumentation as well as impact assessment were discussed with policymakers from India and China (during the first period bilateral meetings) as well as with officials from the World Health Organization (WHO), medical foundations and NGOs (at the first main dissemination event in Melbourne, March 2010). As a result, the HIF was further discussed as a blueprint for bilateral action between India and China, it was included in the WHO debates on ways to increase access to medicines globally and it was also included in discussions between the German foundation Friedrich Ebert Stiftung (FES) and the Global Fund to Fight AIDS, Tuberculosis and Malaria.