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PRESS
RELEASE Press
Release by: Members of the Press, The release of the full TPP texts has confirmed our worst fears on access to generic medicines. Therein lie provisions on patent extensions, market exclusivity for biologic medicines, and data linkage, among other provisions, that will threaten our dependence on affordable generics. Data indicates that for all brand-name medicines requests in Malaysia, 84.7% are substituted by generics.[1] Over the past week or so, TPP supporters have come up with statements on access to medicines stating that the TPP will not have an effect on medicine prices. These statements, made by parties who have zero experience in public health and medicine procurement, are contrary to the evidence and statements made by the World Health Organisation (WHO) Director-General, international humanitarian organisation and Nobel prizewinner Doctors without Borders (M้decins Sans Fronti่res - MSF), the Malaysian Ministry of Health, medical student bodies (American Medical Student Association) and professional medical associations like the New Zealand Medical Association (NZMA) and the Malaysian Medical Association. We cannot continue to be in denial about the impact on access to affordable medication given the wealth of evidence available on TRIPS+ provisions and entry of generics into markets. It would be far more prudent to admit that access to affordable medicines was traded away in the TPP for other goods or favours, whether real or negligible.[2] The WHO DG Margaret Chan four days ago stated: "If these agreements open trade yet close the door to affordable medicines we have to ask the question: is this really progress at all?”[3] Bantah TPPA and the health and patient groups therein asks MITI to seriously consider international scientific evidence[4] on access to medicines and the TPP, including taking the views of international medical experts as aforementioned. We ask Parliamentarians from both sides to vote no to the TPP, and we ask Cabinet to reflect the best interests of the rakyat in terms of reject these arbitrary TRIPS+ provisions. We would like to remind decision-makers that the inability to adequately provide for the health of the rakyat can have tremendous impacts on productivity, the national economy, and the national budget. ANNEX In this statement we would like to rebut several statements made by TPP supporters in various fora, including op-eds in the media: 1. Claim:Data exclusivity & market exclusivity for biologics would be to encourage pharmaceutical companies to market their new medicines early to Malaysia. This would create a pathway for more affordable generic drugs to be brought into the market early. Reality: There is zero evidence of TRIPS-plus provisions resulting in generics being brought into the market early[5]. In addition, an originator company’s decision on how quickly to apply for marketing approval in Malaysia would be factored mainly on market size and other reasons. 2. Claim:The Government has agreed to extend similar data protection to biologics products, so as to provide non-discriminatory treatment. Reality:There is no legal requirement to provide non-discriminatory treatment in this way. The World Trade Organization rules do not require data/market exclusivity on any medicines and the UN Special Rapporteur on the Right to Health has said that developing countries should not agree to this or other TRIPS+ provisions[6]. If Malaysia was so worried about discriminating, then it should have removed data/market exclusivity on small molecules. Since Malaysia is party to the Convention on the Rights of the Child (CRC) which includes the right to health,[7] agreeing to these TRIPS+ provisions in the TPP appear to violate Malaysia’s obligations under the CRC. Malaysia has chosen to provide market exclusivity for biologics in the TPP under US pressure. Biologic medicines are very different to small molecule medicines: they are an increasingly important share of the medicine market , they can be US$569,000/patient/year at monopoly prices and the vast majority are derived from living sources[8] so should not be patented.[9] If they are not patented, then without the TPP’s required exclusivity, generic versions could have continued to have been immediately available in Malaysia at more affordable prices. 3. Claim:These provisions are necessary because they will make companies innovate more. Reality:Pharmaceutical companies are in an ‘innovation crisis’[10]despite TRIPS+ provisions. They are increasing patenting pharmaceutical products for minor modifications. In addition, studies have found that some innovation is actually hampered by stronger intellectual property[11] or that IP does not stimulate innovation.[12] By way of illustration, Italy increased intellectual property rights and this has had little or no impact in rate of invention.[13] A second example is the European Union, which is the most protected pharmaceutical market in the world, but has become less innovative than other regions.[14] 4. Claim:All discoveries, including new uses, will meet the exact scrutiny of patent office examination for novelty and obvious use. Reality:New use patents in any field of technology are very problematic as they evergreen the monopoly. Furthermore, the TPP lowers the standards for novelty and inventive step/non-obviousness for all patents including new use patents. This means that more technology will receive the at least 20 year monopoly of a patent before consumers, farmers and manufacturers can buy it at the cheaper price due to generic competition. Press
Release by: For enquiries please contact: Fifa
Rahman Lim
Ching Wei [1]Chong CP, Hassali MA, Bahari MB and Shafie AA. Generic medicine substitution practices among community pharmacists: a nationwide study from Malaysia. Journal of Public Health 2011; 19(1): 81-90. [2]Re worsening trade balance in: Rashmi Banga, Trans-Pacific Partnership Agreement (TPPA): Implications for Malaysia’s Value-Added Trade (January 2015) Accessed 15 November 2015 [3]Tom Miles, Pacific trade deal could limit affordable drugs: world health chief(12 November 2015) Reuters <http://www.reuters.com/article/2015/11/12/us-trade-tpp-health-idUSKCN0T10X720151112> Accessed 14 November 2015 [4]Gleeson et al. Costs to Australian taxpayers of pharmaceutical monopolies and proposals to extend them in the Trans-Pacific Partnership Agreement.Medical Journal of Australia 2015; 202(6) doi: 10.5694/mja14.01682; Ryan B Abbott, Rania Bader, Lina Bajjali, Taher Abu ElSamen, Thamer Obeidat, Hanan Sboul, Mustafa Shwayat and Ibrahim Alabbadi. The price of medicines in Jordan: the cost of trade-based intellectual property (2012) 9(2) Journal of Generic Medicines 75–85 [5]As in the case of the blockbuster lung cancer drug Alimta, which had extensions of patents for a minor modification involving vitamin usage. Lilly: U.S. Court Rules in its Favor on Alimta Patent Accessed 14 November 2015 [6] United Nations General Assembly, Report of the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, Anand Grover (31 March 2009) http://www2.ohchr.org/english/bodies/hrcouncil/docs/11session/A.HRC.11.12_en.pdf [7]Convention on the Rights of the Child, Article 24 [8]Overview of the Food and Drug Administration and the Center for Biologics Evaluation and Research <http://www.fda.gov/downloads/BiologicsBloodVaccines/InternationalActivities/UCM273181.pdf> Accessed 15 November 2015 [9]Third World Network, Preliminary analysis of biologics exclusivity Accessed 16 November 2015 [10]Cynthia Ho, ‘Sovereignty under Seige: Corporate Challenges to IP Decisions’ (2015) 30(1) Berkeley Technology Law Journal [11]Lerner J, 150 Years of Patent Protection, Harvard MA, Harvard Business School Working Paper (2001), Monitoring Financial Flows for Health Research 2005: Behind the Global Numbers by Global Forum for Health Research page 31. The Global Forum for Health Research is funded by the World Health Organization, the World Bank, the Rockefeller Foundation and various national governments. This Chapter of the Report was written by Donald Light who in addition to being an academic is a member of the Business Advisory Council of the Republican Party and a member of the President’s Business Commission. [12]Deardorff A, ‘Welfare Effects of Global Patent Protection’ Economica 1992; 59: 35-51 and Branstetter LG ‘Do Stronger Patents Induce More Local innovation?’ in KE Maskus and JH Reichman (eds) International Public Goods and Transfer of Technology Under a Globalized Intellectual Property Regime, Cambridge University Press. Cambridge 2005; 309-320 [13]Commission on Intellectual Property Rights, Study Paper 1b, Intellectual Property Rights, Technology and Economic Development: Experiences of Asian Countries, Dr Nagesh Kumar. [14]EGA press release: Brussels, 10 November 2005, a Call to Review the Patent System, IPH 10/11/2005
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