TRIPS and intellectual property rights

Transcription

1 1 10 minutes - 8 pages 19 February 2015 Human Rights Council, Social Forum, February 2015, Room XII, Palais des Nations, Geneva, Access to medicines and intellectual property rights and human rights/ TRIPS to TRIPS plus to FTA plus: where are human rights in the equation? Introduction It is a privilege and honour to participate in this social forum Which despite institutional and mandate shifts over the last 12 years has kept true to its original focus on how globalization impacts human rights for the most vulnerable the question of access to medicines is arguably one of the most explicit examples of how economic and trade rules can derogate from human rights to health and life. i And we are at a critical juncture- Despite multiple efforts to address access to medicines outside of HIV/AIDS material access gains are so negligible To suggest that the primary determinants of the drug gap are not being responded The global drug gap poses tremendous challenges for the international community And provides a signal of the extent to which they are willing to give teeth to fundamental human rights like health when powerful commercial and trade interests point in other directions. my talk today will give a snapshot of this landscape from feet tracing a thread through relevant trade, human rights and global health law and policy that have responded to this challenge. Access to medicines and pricing it is worth restating the basic facts: the global drug gap poses tremendous human rights and development challenges 1billion people cannot access essential medicines either because there are not enough drugs available in public health systems or because the drugs that are there or in the private sector are either priced out of reach and not covered by health insurance

2 2 leaving people to make terrible choices: between food and health care, or health care and impoverishment a reality Dr Deqa Mohamed spoke so eloquently to yesterday ii the centrality of medicines to realizing human rights, development and health system imperatives iii, is why essential medicines are understood as a core obligation of states under the right to health why the WHO recognizes medicines as a fundamental building block of health care systems capable of providing universal health coverage and why medicines are included within development policy like the millennium and sustainable development goals yet the policy space that countries have to provide affordable medicines is bound sometimes wholesale by trade rules around intellectual property rights and this is important because to restate the linkages: affordability is a fundamental determinant of access to medicines, price is a fundamental determinant of affordability, and patents are a fundamental determinant of price TRIPS and intellectual property rights the global community had been addressing access to medicines long before 1995 but the introduction that year of the TRIPS agreement was a major game changer which required countries acceding to the WTO to give patent protection to pharmaceuticals something that around 50 countries including India had not done previously iv even in countries with patents the requirement of 20 year patents conferring exclusive rights to prevent non-consensual use was unprecedented and the monopolistic pricing that resulted saw sometimes dramatic increases in drugs prices as in Malaysia where drug prices increased by 28% per year between 1996 and 2005 (Smith, Correa, Oh, 2009, p689).

3 3 Trips does have provisions to give governments policy space to meet public health and social welfare imperatives Like delaying the onset of the agreement for LDC, Tailoring patent criteria or excluding patents for inventions to protect health and life and permitting countries to manufacture or import generic versions of patented drugs or import cheaper versions of patented drugs under measures like compulsory licenses and parallel imports these are the trips flexibilities and global debates focus on them because they allow policy makers to ensure that high prices resulting from exclusive patenting rights don t negatively impact public health imperatives and because their use attracts tremendous opposition from companies and host governments in the form of litigation, drug removals, trade sanctions and diplomatic pressures at the same time regional and bilateral free trade agreements are restricting TRIPS flexibilities in ways that extend monopoly pricing and limit market entry for generic medicines with stark impacts on impacts on affordability for example, Oxfam found that the US-Jordan FTA produced a 20% increase in drug prices after its introduction These strictures came to public light in 2001 when activist and media attention to corporate litigation in South Africa to prevent affordable medicines legislation when millions were dying annually from HIV/AIDS caused so great an outcry that African countries at the Doha round of WTO negotiations were able to push through the Doha Declaration on trips and public health to give legal clarity to state use of these flexibilities Doha Declaration Doha explicitly endorsed the right of WTO members to protect public health and promote access to medicines for all, and to use TRIPS flexibilities to the full to do so [4] Specifying that these flexibilities

4 4 included the right to grant compulsory licenses [5.b] and to use parallel importing and asking the TRIPS council to find a solution to inability of WTO members with insufficient or no manufacturing capacities to effectively use compulsory licensing [para 6] and to extend the LDC waiver from applying TRIPS to pharmaceuticals to 2016 [para 7] Para 6 system this prompted the development of the para 6 system so called because of its paragraph number in the doha declaration to enable countries to export drugs to LDC without domestic manufacturing capacity which the TRIPS Council proposed in 2005 as a permanent amendment to be incorporated into TRIPS when it was accepted by 2/3 of WTO members (deadline of 2007, extended to 31 December 2015 in 2013) v but the system has been used only once by a Canadian generic manufacturer who exported arvs to Rwanda the cost and complexity of the Canadian experience suggest why the para 6 system is used so seldom over six-years the manufacturer made two drug shipments and declined to renew the licence (Apotex 2010), and industry opposition saw legislative efforts to streamline the process voted down twice in parliament (Galloway 2012; Toronto Star 2012). But another reason countries aren t using the system is because they buying from countries like India which don t need to issue compulsory licenses. vi India s role India s role in providing access to affordable generics is of crucial importance Something shown clearly with ARVs, the greatest success of global access campaigns Of the 13.6 million people accessing ARVs in 2014 vii It is estimated that 80% are dependent on Indian generics (Waning et al., 2010). India has this generic manufacturing capacity because it took full advantage of transition periods for TRIPS

5 5 But the introduction in 2005 of pharmaceutical patents means it will no longer be able to supply generics of newer ARVs and other drugs other than through trips flexibilities The Indian gov has incorporated these into law viii curtailing evergreening by refusing patents if companies cannot show clear novelty or efficacy As it did when Novartis applied for a patent on a new formulation of Gleevec, a blood cancer drug A decision upheld in 2013 by the Supreme Court of India and issuing a compulsory license in 2012 for an expensive cancer drug patented by Bayer now Doha is explicit that states can use flexibilities like compulsory licenses to ensure access to medicines but as far as the companies and their host governments are concerned Doha never happened and india has faced several instances of corporate litigation over patent denials ix and a full range of US diplomatic and trade pressures x With worrying signs that these might be prompting IP policy reform Within the UN system the policy response has been mixed MDG8E access to medicines was included in the original millennium development goals largely because of how social pressures turned this issue into a focal point for political actors but its location and formulation reflected an institutional mindset at the time which was very reluctant to upset the political and commercial interests at stake with the goal articulated as being to provide access to affordable essential drugs in developing countries in cooperation with pharmaceutical companies xi an approach that seemed to preclude ostensibly uncooperative actions like compulsory licenses xii

6 6 this response took at face value corporate arguments that strict intellectual property rights in developing countries were critical to protect the innovation cycle that produced new medicines a plethora of studies and reports since then confirm that patents in developing countries do not stimulate R&D of new medicines the 2006 report of the WHO Commission on intellectual property, innovation and public health CIPIH report put it starkly: For diseases affecting millions of poor people in developing countries, patents are not a relevant factor or effective in stimulating R&D and bringing new products to the market. xiii GSPA this Commission s report prompted the most comprehensive global policy response yet in the global strategy and plan of action on intellectual property, innovation and public health produced by an intergovernmental working group between 2006 and 2008 and adopted by the World Health Assembly in May 2008 which specified over a 100 actions to address medicines access and innovation in eight areas The Global strategy makes crucial recognitions around intellectual property rights that countries had general authority to use flexibilities recognized in Doha And that appropriate pricing policies should include use of such flexibilities [para 37 and 38]. Identifying flexibilities like research exceptions (2.4.e) and export to countries with no manufacturing capacity (5.2.d), (also regulatory exceptions (6.3.a) and abuse of intellectual property rights (6.3.f)) But equally significant is what the Global Strategy did not say No mention of compulsory licensing the flexibility at the heart of these debates and explicitly endorsed in Doha Or parallel imports, and restrictions of data-exclusivity to enable generic market entry All flexibilities restricted or removed in fta and which face legal or economic pressures The IGWG also stepped back from trips plus rights

7 7 With the final strategy deleting a section cautioning states not to adopt TRIPS-plus protection in bilateral trade agreements Instead suggesting that states take into account, where appropriate, the impact on public health when considering adopting more extensive intellectual property rights than in TRIPS [5.2b] While the strategy gives great clarity to action in many other places, Its failure to identify key flexibilities and common practices limiting them Weakly commits to supporting key strategies that can impact on pricing And to guarding against political and economic interference in this area Raising questions about whether the strategy could respond to key domains of drug access xiv SDGs on medicines Certainly we see progress in current proposals for sustainable development goals the Open Working Group has proposed a health target xv on medicines that calls for states to provide access to affordable essential medicines and vaccines and affirms the right to use TRIPS flexibilities to the full shows that the policy response has evolved from the MDGs But remains to be seen if it survives the intergovernmental negotiations to finalize goals State of play in 2015 It is troubling then that this thicket of global policy has had almost no impact on primary barriers to affordability trips plus intellectual property rights are not only expanding but getting stricter - with trips flexibilities being limited and even eradicated xvi and outside of ARVs the inaccessibility of medicines for over a billion people hasn't budged as the 2014 MDG gap task force report indicates, despite more coordination in implementing coherent national policies aligned to global agreement

8 8 essential medicines remain unaffordable and insufficiently available in developing countries. [53] xvii Conclusion I will conclude with three observations first, is that when some of the most important contributions that UN can make is in language, vague statements that avoid identifying practices that sustain high prices risk turning right to health into nothing more than paper promises HRC resolutions have made important normative advances recognizing access to medicine as a fundamental element of the right to health [1]; requiring states to ensure actions in international organizations and agreements take account of this right, 1 It is perhaps time to move forward again beyond speaking generally of TRIPS flexibilities in Doha To specify practices like compulsory licensing as measures with proven efficacy in bringing down drug prices And naming the imposition and acceptance of TRIPS plus intellectual property rights in ftas as violations of the right to health That should be integrated into the universal periodic review to hold states implicated to account xviii (2) my second observation is while full use of TRIPS flexibilities may be the primary solution on the table let us not believe that it is anything but a poor solution it turns the fundamental human right to health and affordable medicines into a rigidly restricted exception to a property right And affordable medicines the price developing countries must pay to enter wealthy markets and the global economy For those who would see arguments of this kind as pure naiveté unlinked to the reality of the global economy

9 9 I will remind you of Albie Sachs s observation that had Mandela been more pragmatic and less naïve he would have accepted second class status in a racist society [harvard roundtable 1993] And Stephen Lewis s indication yesterday: That the UN Commission on HIV and the Law has recommended that WTO members urgently suspend TRIPS for essential drugs for low and middle-income countries and that the UN secretary general convene a new body to recommend a new intellectual property regime for drugs. Finally, it is worth noting that transformation in this area has always come from social actors Who brought the full weight of human rights law and social pressures to bear on naming, shaming and prodding appropriate action from international institutions, companies and their supporting government in relation to AIDS treatment. Their successes underscore that the global drug gap is created and reinforced by human decisions and action and can be undone by human decisions and action. Thank you

10 10 i Something the HRC recognized in 2009 with an important resolution recognizing access to medicine as a fundamental element of the right to health[1]; which required states to ensure that their actions in international organizations and agreements took account of this right, i and in particular that under wto law members states had the flexibility to protect public health and promote access to medicines ii in countries like Somalia, where daily and even weekly income can be less than a dollar a day, health care becomes a far secondary priority to food and diarreha poses even greater threats than HIV/AIDS iii The WHO conceptualizes health systems in terms of six building blocks whose interplay helps in achieving desired health outcomes through ensuring universal coverage and equitable access to quality assured and safe health care: Service Delivery; Health Workforce; Information; Medical Products, Vaccines & Technologies; Financing; Leadership / Governance. Trilateral study Generic medicines policies which aim to increase the market share of cheaper generic medicines, control prices of medicines and regulate the level of medical expenses reimbursement are key policy interventions to control health budgets, and make medicines and other health products and services more affordable. [156] iv In 1988, at an early stage in the TRIPS negotiations, a WIPO report cited 49 countries that either did not grant patent protection for pharmaceutical products at all or only provided a limited form of such protection. Some of these countries also excluded pharmaceutical processes.49 The duration of patents also varied considerably from country to country. [56] v 17 have notified of relevant changes to domestic law to implement (11 as exporters (Albania, Canada, Croatia, EU, Hong Kong, India, Jordan, Norway, Oman, Switzerland, Taipei), 1 as importer (Singapore), 4 as exporter/importers (Botswana, China, Phillipines, Korea). vi As Ghana did in 2005 instead of importing from Canada where the drugs where patented vi Certainly the geography of states that have not accepted the TRIPS amendment is telling vi Most African countries, Russia, most SE Asia It likely suggests that they do not see the system as pertinent to their needs vii UNAIDS, Fast Track: Ending the AIDS Epidemic by 2030, Countries further expanded access to priority HIV programmes in the first six months of With 13.6 million people receiving antiretroviral therapy as of June 2014 (Fig. 1), viii At the time of the ruling, the Novartis brand of the drug, Glivec, was selling for the equivalent of $2,600 a month in India, while the generic equivalent is available in India for just $175 a month.22 [61] Patralekha Chatterjee, India s patent case victory rattles Big Pharma, the Lancet, vol.381, Issue 9874, p [trilateral study] ix 2013 Bayer legal challenge to compulsory license on cancer drug [Bayer v Union of India, Intellectual property Appellate Board, OA/35/2012/PT/MUM, 4 March 2013], Abbott et al, p21. x USTR 301 reviews, US-India Trade Policy forum and high-level IP working group xi MDG 8E: in cooperation with pharmaceutical companies, provide access to affordable essential drugs in developing countries. See The original formulation of this commitment in the Millennium Declaration was to encourage the pharmaceutical industry to make essential drugs more widely available and affordable by all who need them in developing countries. United Nations General Assembly, United Nations Millennium Declaration, U.N. Doc. A/RES/55/2, 18 September 2000, para. 20. xii measured via the proportion of the population with access to affordable essential drugs on a sustainable basis (United Nations Statistics Division, 2013). Its inclusion brought global access to medicines within the scope of progress monitoring including through annual reports from the MDG Gap Task Force reports which provide important snapshots of global progress. But the goal failed to quantify a target or timeframe Didn't speak of flexibilities even in generality, and xiii Recognition reinforced in trilateral study: The circular model of health innovations illustrates a critical reality: the current market-driven innovation cycle works better for developed countries where effective demand for health products is matched by the ability to pay for them. In contrast, for diseases that predominantly affect patients in developing countries, there is a critical gap in the availability of incentives that fuel the conventional innovation cycle. While there is an urgent need for new medications for diseases that predominantly affect developing countries, that market is characterized by limited purchasing power, coupled with the lack of health insurance systems in many countries. [109] xiv Similar mildness in approach to proposals to delink innovation from price with the Consultative expert working group on R&D proposal of a global R&D treaty to codify state contributions to R&D. Rejected by WHO member

11 11 states who chose instead to have states establish national R&D observatory and calling on the WHO secretariat to establish to establish a global health R&D observatory to monitor health R&D to identify gaps and opportunities for health R&D and defining priorities in consultation with Member States and other relevant stakeholders xv on with regard to the framework convention on tobacco control, R&D of vaccines and medicines, access to affordable essential medicines and vaccines, increased health financing and health workforce, and strengthening country capacity to deal with national and global health risks xvi and obstructing the movement of generic medicines through international borders under measures to strike out counterfeit meds. xvi the only remaining aperture through which policy for affordable medicines can operate is being closed and india the primary provider of these medicines is being stringently targeted. xvii Essential medicines remain inadequately stocked in low and middle-income countries With an average availability of generic medicines of around 55% and 66% in the public and private sectors respectively [54] And they also remain highly priced With generics in low and lower middle income countries often 3 times higher than international reference prices in the public sector and over 5 times higher in the private sector [54-55]. And originator drugs on average 4 times more expensive than generics And sometimes as is the case in Indonesia, originator drugs are 18 times higher than generics (all from MDG Gap report 2013, p60-61). xviii 9. Also encourages all States to consider including in their national reports, to be submitted to the universal periodic review mechanism, information on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, particularly on measures taken to promote access to medicines;