1^st Briefing and Consultative Meeting on Select Agenda Items of the
62^nd World Health Assembly, 2009
Organized by the Public Health Foundation of India and Centad

The meeting was attended by members of public interest organizations, researchers, academicians and pharmaceutical industry representatives. The meeting sought to highlight and sensitize participants on some of the contemporary public health concerns in India as well as other developing and least developed countries in the wake of upcoming World Health Assembly (WHA). The meeting was opened with the address by Dr. Shaktivel Selvaraj (PHFI) who outlined the objective of the meeting. The objective of the meeting was to discuss the select items of the upcoming WHA agenda viz. the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPOA), World Health Organization (WHO)’s roles and responsibilities on health research and the WHO-IMPACT (International Medical Product Anti-Counterfeit Taskforce) definition of counterfeit medical products.ⁱ It was hoped that such a discussion would enhance civil society participation and strengthen response from academia and policy makers on related issues. He informed the participants that the meeting was the first of the annual PHFI- Centad Discussion series planned to be held henceforth. Dr. Selvaraj’s address was then followed by a round of self-introduction by the participants.

Ms. Tina Kuriakose (Centad) made the first presentation. Her presentation focused on counterfeit policy making, with a special reference to the definition of counterfeit medical products provided by the WHO sponsored IMPACT. She began her presentation by contextualizing the politics of counterfeiting. She pointed out that in the last two decades there have been concerted efforts by developed countries to not only harmonize intellectual property rights (IPR) standards but also enhance IP enforcement through TRIPs-plus measures. IP maximalism has stretched across the WTO and today is evident in a number of international fora. She stated that allegations of trade in “counterfeit” medicines needs to be viewed in the light of agenda setting by the powerful lobby of pharmaceutical manufacturers in developed countries like the USⁱⁱ and evidenced in aggressive forum-shifting.

Today a diverse set of organizations are seized of the issue concerning trade in “counterfeit” medical products, irrespective of the scope of their mandate or powers. Some of the key initiatives in this regard include EC Regulation no. 1383/2003; the 2005 G8 summit in Gleneagles; the 2007 World Customs Organisation’s (WCO) Standards Employed by Customs for Uniform Rights Enforcement (SECURE) and the 2007 Anti-counterfeiting Trade Agreement (ACTA). Of these, the WCO instituted SECURE has invoked grave concern on the part of developing countries owing to the overbroad powers granted to customs authorities to detain, seize, forfeit and dispose of goods that infringe IPRs, even in the absence of evidence of prima facie infringement. Ms. Kuriakose recounted the recent use of similar provisions in the EC Regulation no. 1383/2003 that led to the seizure of generic drugs of an Indian manufacturer-Dr. Reddy’s Labs- bound for Brazil and impounded in Amsterdam. In this regard, the Indian Commerce Secretary, in an exceptionally strongly-worded statement expressed displeasure over EU’s “act of piracy.”ⁱⁱⁱ

The real bone of contention however in the issue relating to “counterfeit medical products”, is the open ended WHO-IMPACT definition of the same. Ms. Kuriakose pointed out that the WHO defines counterfeit medicines as those which are deliberately and fraudulently mislabeled with respect to identity or source. Thus, the WHO-IMPACT definition mixes issues of spurious drugs and substandard drugs with intellectual property infringement. Furthermore, the IMPACT definition applies "to the product, its container, packaging or other labeling information" and includes "both branded and generic products." Indeed, serious concern was raised against the adoption of the IMPACT definition considering its potentially adverse impact on the access to drugs caused by branding legally produced generic drugs as counterfeit drugs. Ms. Kuriakose recalled the strong civil society partnership against the adoption of the IMPACT definition of “counterfeit” medical products and related TRIPS-plus measures advocated by the WHO taskforce under the guise of public health concerns. She also asserted that though the issue of counterfeit medical products had been removed at the last minute from the 62nd World Health Assembly’s Agenda, developing countries need to be alert to a resuscitation of the issue both at the WHO and elsewhere.

In the ensuing discussion, Dr. Mira Shiva (AIDAN/IHES) emphasized that developing countries like India should not debate on the issue of counterfeit medical products solely from an industry perspective. Safety and quality of medicines is a legitimate public health concern. Some of the important questions that can be raised on the issue of counterfeit medicines include an enquiry into the “remit” of the WHO to deal with IPR concerns vis -à–vis safety and quality of drugs and whether developing countries would be better served in steering these discussions to the WTO. Dr. Shiva also indicated that a closer scrutiny of the organizations and participants at related WHO meetings would help reveal the intent and politics of the policy “contributions” at the WHO. Dr. Dinesh Abrol (NISTADS), in response to Dr. Shiva’s comments asserted that developing countries should exert concerted efforts towards focusing the concern of the WHO on other equally important public health problems. According to Dr. Abrol, access to affordable medicines especially in the developing world is crucial for the realization of the right to health and the WHO should not be allowed to ignore this reality. Commenting further on the working of the WHO, Dr. Abrol, also drew attention to the fact that the WHO receives a large chunk of its funds from the European Union which tends to impact the manner in which the Organization conducts its affairs. He also informed that there are divergent opinions on the issue of counterfeit medicines even amongst the familiar coalition of public interest organizations. In this regard, he urged the participants to identify friends and allies in the fight against counterfeit policy making.

The second presentation at the meeting was made by Dr. Abrol, who spoke on the prioritization of research and development needs of developing countries in the GSPOA. Dr. Abrol said that the implementation of GSPOA is taking place very slowly. Dr. Abrol shed some light on the lack of innovation in neglected diseases, disease burden, poor purchasing capacity of developing countries and the negative fallout of the Trade Related Intellectual Property Rights (TRIPS) Agreement on access to affordable medicines. First issue to be discussed in this regard was the GSPOA formulated by the WHO in its 61st General Assembly (WHA) in order to address asymmetries relating to innovation, intellectual property and public health. The GSPOA categorizes the issues related to public health, innovation and intellectual property into eight elements and sub-elements (including, R&D financing, public-private partnership, innovation, regulating capacity, transfer of technology, application and management of IP), to be addressed equally and with no preference. Gaps in research on Type II and Type III diseases have been mentioned in the GSPOA. The “urgent” need to identify the specific R&D needs of developing countries in relation to Type III diseases is also part of the WHO GSPOA. India was an active participant in the negotiations leading to the creation of the GSPOA text and as one of the largest producers and exporters of generic medicines, hopes that an effective outcome of the GSPOA would further the health and developmental needs of the developing countries.

According to Dr. Abrol, intense negotiations by developing countries allowed India to earn an extended transition period for IP protection of product patents in pharmaceutical products. This transition period (1995-2005) has greatly helped the domestic industry. India’s present concern after the 2005 amendment to the Patent Act should however be to ensure that new bilateral and multilateral undertakings are not detrimental to the implementation of such flexibilities. Dr. Abrol stressed that a stronger IPR regime has not brought India foreign direct investment, technology transfer or R&D in neglected diseases. He also stated that while considering the Indian policy and recent legislations, it can be seen that the recommendations made in the GSPOA have not been fully internalized by the Indian policy makers. The recently proposed Bill on public funded research and development and intellectual property management focuses on development and research only in areas that have commercial potential, which might hamper innovations in the field of neglected diseases.

Dr. Abrol firmly recommended disease-wise mapping of priorities in Indian research and development. This can be gradually achieved by undertaking a detailed analysis of the lacunae in the field of research and development. The process has already been set in motion with the establishment of new Department of Health Research (DHR) within the Ministry of Health. DHR has its own secretary, deputy secretary and separate budget. Another cause for concern in R&D opportunities in India is the plummeting number of students opting for biology and medicine as viable career options. India also does not have an inventory of health researchers. He said that there is a need to direct urgent attention to translational research as there exists a wide range of problems such as gaps in technology utilization ability and absence of bridging organization. He also mentioned about the issues of duplication in research as there is no proper co-ordination among research institutions and researchers. While discussing about some of the attempts of the Indian government, he said that the effort made in the area of diarrheal research is the only notable effort made in India. Besides this, in the area of traditional medicines, the Government of India initiated the Golden Triangle project and also established the Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (AYUSH). However, he pointed out that AYUSH’s main focus is not on neglected or Type III diseases. Other efforts mentioned by Dr.Abrol were those undertaken by: 1) ICMR’s Centre for Advanced Research (CAR); 2) Regional Research Laboratories (RRL); 3) Indian Institute of Integrative Medicine (IIIM), Jammu (IIIM) and 4) New Millennium India Technology Leadership Initiative (NMITLI) of CSIR. Collaborative efforts with University of Mississippi, IBSA and collaboration with China and Sri Lanka are other bold steps in the field of traditional medicines. He also suggested that the health research policy draft enunciated should be adopted at the earliest.

Dr. Abrol also pointed out that the Government has failed to achieve the target of investing two per cent of GDP on health. In the 10th and 11th Five Year Plans in India, fortunately more funds have been allocated for biomedical R&D. Dr. Abrol also suggested that the National Health Innovation Policy and Plan should be implemented at the earliest. He also pointed to the fact that private investment in research has escalated to a considerable extent in the past ten years. The research landscape has changed drastically with extensive private participation of entities such as the Gates Foundation. While discussing about the research funding, he noted that grants by diseases in 2005 were highest for malaria but not so much for Type III diseases. Furthermore, analysis shows that there are serious mismatches between the burden of diseases, R& D priorities and inventive activity orientation. By looking at USPTO patent grants,^iv Dr. Abrol assessed highest number of patents granted for inventions related to Type I diseases and the least for Type III diseases. India appears to be in a similar situation. Dr. Abrol pointed out that, by analysing the papers published during 2001-2006 in Landscape Online, one can see that more number of publications were there in Type III diseases.^v

On the issue of IPRs and their potential to incentivize innovation and research, Dr. Abrol expressed concerns over the revised Mashelkar Committee report, Public Funded IP bill (Indian Bayh Dole Act), Innovation Act, Patent Manual and the wrong understanding of patent jurisprudence among policy makers and suggested that developing countries draw lessons from the Japanese experience in IP capital management. The Japanese government chose not to grant product patents for pharmaceutical patents in 1977 and used a number of other domestic legislative measures to limit the possibilities of patent thickets thereafter. Moreover, Japanese patent office allowed only a single claim for patents in pharmaceutical sector, prior to 1989. The Japanese IPR policy has been diffusion-oriented and requires fulfillment of conditions such as residence requirement of the applicant, filing of claims in Japanese and also allows ample time for pre-grant opposition to patents. In order to enhance R&D in accordance with health needs, India must likewise work towards an IPR policy that combines inputs from all relevant stakeholders inter alia the government, civil society members, lawyers, chemists and engineers.

In conclusion, Dr. Abrol stressed the need to delink R&D incentive from monopoly prices. To this effect, he recommended resort to alternatives in the nature of prize funds, patent pools, health impact fund (HIF), open source collaboration, R&D treaty and differential pricing for developing nations (Barton proposal). The meeting was finally concluded with a briefing by Dr. Sakthivel Selvaraj. He also thanked all the participants for their active participation.

ⁱThe issue of counterfeit drugs was also to be a part of the 62^nd WHO Assembly but was removed a few days before the Assembly was held.

ⁱⁱSee Pharmaceutical Research and Manufacturers of America (PhRmA) Special 301 Submission (2009) available at http://www.ipophil.gov.ph/ipenforcement/phrma_submission.pdf

ⁱⁱⁱSee Summary of Commerce Secretary’s Speech Expressing Serious Concerns over Generic Seizures and Anti-counterfeiting campaigns against Indian Pharmaceutical Products available at http://www.centad.org/focus_77.asp

^ivIn 2001-2006 periods, USPTO granted 39 patents in innovation related to Type I diseases, 28 in Type II diseases and 18 in Type III diseases.

^v195 papers were published on Type I diseases, 184 papers in Type II have and 203 papers in Type III.