UN report strengthens case for patent law reform in SA and other developing countries

-        We urge all governments to urgently adopt and act on UN recommendations to safeguard right to health.
-        South Africa must show the way by leading developing countries, especially the BRICS, the SADC and the AU, in adopting and building on the recommendations
JOHANNESBURG, 14th SEPTEMBER 2016: The Treatment Action Campaign (TAC) and SECTION27 welcome the release of the United Nation Secretary General’s High-Level Panel Report on Access to Medicines. This UN report makes a number of important recommendations regarding how society pays for medicines and for the research and development of new medicines. While we welcome several recommendations, they should be viewed as a minimum standard that need to be built upon in order to fully remedy the failures in the current patent system and ensure everyone has access to the medicines they need.
We urge the South African government, and all other governments to engage with the recommendations of the UN High-Level Panel. In particular, we urge the South African Cabinet to urgently discuss the report and consider the adoption of its recommendations. Access to existing medicines and the development of new medicines is literally an issue of life and death for thousands of people. We ask governments to treat it as such and accordingly to give this report the priority attention it deserves. In South Africa, the government has a constitutional duty to take reasonable legislative and other measures, within its available resources, to achieve the progressive realisation of the right of access to healthcare services.
Below we highlight some of the key recommendations and their implications:
1.     The report recommends that countries make full use of health safeguards available under international law (TRIPS flexibilities). It makes particularly strong recommendations on amending laws to avoid patent ever-greening and to allow for more workable compulsory licensing provisions. These recommendations are in line with the objectives of the Fix the Patent Laws campaign (of which TAC and SECTION27 are members). South Africa has delayed the law reform process to make use of these public health safeguards by over 10 years, despite repeated calls by TAC, SECTION27 and other organisations concerned about public health in South Africa.
We refer to two key recommendations that we urge the South African government to adopt and act on urgently:
“WTO Members should make full use of the policy space available in Article 27 of the TRIPS Agreement by adopting and applying rigorous definitions of invention and patentability that are in the best interests of the public health of the country and its inhabitants. This includes amending laws to curtail the ever-greening of patents and awarding patents only when genuine innovation has occurred.”
“Governments should adopt and implement legislation that facilitates the issuance of compulsory licenses. Such legislation must be designed to effectuate quick, fair, predictable and implementable compulsory licenses for legitimate public health needs, and particularly with regards to essential medicines. The use of compulsory licensing must be based on the provisions found in the Doha Declaration and the grounds for the issuance of compulsory licenses left to the discretion of governments.”
Unfortunately the report fails to make concrete and actionable proposals to put a stop to all TRIPS plus measures that undermine access to medicines in trade agreements. To properly redress this ongoing threat, governments must build on what is contained in the report and reject all TRIPS plus measures in trade agreements.
2.     The report also acknowledges that countries that attempt to use these WTO-approved legal safeguards often face severe pressure from certain developed  countries and the pharmaceutical industry. Such an acknowledgement in a UN report is remarkable. The report states as follows:
“Many governments have not used the flexibilities available under the TRIPS Agreement for various reasons ranging from capacity constraints to undue political and economic pressure from states and corporations, both express and implied. Political and economic pressure placed on governments to forgo the use of TRIPS flexibilities violates the integrity and legitimacy of the system of legal rights and duties created by the TRIPS Agreement, as reaffirmed by the Doha Declaration. This pressure undermines the efforts of states to meet their human rights and public health obligations.”
Unfortunately the report stops short of recommending bold punitive measures against countries who exercise such undue pressure. Building on the report’s recommendation it should be mandated that all UN Member States should reaffirm their commitment to the anti-retaliation principle and sovereignty of WTO Members in complying with TRIPS as reflected in Article 1.1 of the TRIPS Agreement. Unilateral retaliation against countries using or intending to use TRIPS flexibilities should be deemed a violation of the TRIPS Agreement.
3.     The report makes important recommendations regarding neglected areas of medical research and recognises that the patent system has failed to incentivise sufficient R&D for diseases like tuberculosis (TB being the infectious disease that currently kills most people on the planet – approximately 1.5 million people per year). It states that “It is imperative that governments increase their current levels of investment in health technology innovation to address unmet needs.” The report doesn’t just argue for greater investment, but also for changes to the ways in which governments invest. These include ensuring that publicly funded research is licensed on terms more sensitive to public health needs and supporting innovation models such as innovation inducement prizes and the pooling of intellectual property.
4.     We welcome the reports strong endorsement of a binding R&D convention or agreement. We consider such a convention to be the most realistic prospect for solving the ongoing crisis of underinvestment in R&D for diseases impacting mostly poor people. It recommends as follows:
“Building on current discussions at the WHO, the United Nations Secretary-General should initiate a process for governments to negotiate global agreements on the coordination, financing and development of health technologies. This includes negotiations for a binding R&D Convention that delinks the costs of research and development from end prices to promote access to good health for all. The Convention should focus on public health needs, including but not limited to, innovation for neglected tropical diseases and antimicrobial resistance and must complement existing mechanisms.”
We urge the South African government to take a leading role  in the negotiation of and establishment of such a binding  R&D convention.
5.     The report makes a number of excellent and wide-ranging recommendations regarding R&D transparency. At present pharmaceutical companies share very little information about their R&D spending. This lack of transparency is particularly problematic given the extremely high prices being charged for many new and old medicines. A number of states in the United States are already considering legislation relating to transparency of pharmaceutical R&D and/or price-setting. The report recommends as follows:
“Governments should require manufacturers and distributors of health technologies to disclose to drug regulatory and procurement authorities information pertaining to: (1) the costs of R&D, production, marketing and distribution of health technology being procured or given marketing approval with each expense category separated; and (2) any public funding received in the development of the health technology, including tax credits, subsidies and grants.”
We urge legislators in South Africa and all other countries to adopt and act on this recommendation in the interests of public health and to take into account this information for the purposes of price-setting.
It also makes the following welcome recommendations regarding clinical trials transparency. The required legal and/or regulatory steps must urgently be taken to ensure that the South African Health Products Regulatory Authority can implement these recommendations. (TAC is a member of the #AllTrials campaign which advocates for the results of all clinical trials to be made public)
“To facilitate open collaboration, reconstruction and reinvestigation of failures, governments should require that study designs and protocols, data sets, test results and anonymity-protected patient data be available to the public in a timely and accessible fashion. Those undertaking clinical trials must not prevent researchers from publishing their findings.”
“Governments should require that the unidentified data on all completed and discontinued clinical trials be made publicly available in an easily searchable public register established and operated by existing mechanisms such as the WHO Clinical Trials Registry Platform, clinical trials.gov or in peer reviewed publications, regardless of whether their results are positive, negative, neutral or inconclusive.”
6.     The report recognises that health and human rights considerations have often been undermined in the development of trade agreements. The report makes a number of recommendations to help address this imbalance. We recommend that the South African government and all other governments adopt and acts on the following recommendation as soon as possible:
“Governments must review the situation of access to health technologies in their countries in light of human rights principles and States' obligations to fulfil them, with assistance from the Office of the United Nations High Commissioner for Human Rights (OHCHR) and other relevant United Nations entities. The results of these assessments should be made publicly available. Civil society should be financially supported to submit their own shadow reports on innovation and access to health technologies. Such national reviews should be repeated at regular intervals.”
While a number of the less ambitious things TAC, SECTION27 and our allies internationally argued for are included in the report, many important proposals in relation to human rights, the failings of the patent system and reform of the IP regime have not been included. In particular we call for urgent discussion within UN forums on a new IP regime for pharmaceutical products that is consistent with international human rights law and public health requirements, while at the same time safeguarding the justifiable rights of inventors. We stand by the submissions we made and endorsed and will continue to advocate for an alternative to the current IP regime that prioritises human rights above all.
We understand that the panel was forced into making certain compromises – some at the last minute. For example we are aware that a minority of panel members rejected at the final hour a recommendation for the near automatic issuance of compulsory licenses on essential health technologies. While these compromises are disappointing, this is not unexpected given that both the multinational pharmaceutical industry and generic medicines industry had representation on the panel and ample opportunity to make submissions to the panel and influence its work. While this has led to some disappointing compromises, it at least shows consensus on the moderate recommendations included. We urge the rapid adoption of these recommendations.
Furthermore,  the report opens the door for South Africa and the BRICS countries to build on this momentum and advocate for more fundamental change, including the renegotiation of the TRIPS Agreement. We urge our government to make full use of this window of opportunity.
In February this year TAC and SECTION27 made three submissions to the panel and endorsed an additional four made by partner organisations. We also held a demonstration when the panel visited South Africa for public hearings in March. At that demonstration we handed the panellists the Johannesburg Declaration –a joint declaration by 26 organisations from across the world. Many of the demands of the Johannesburg Declaration has not been met. For more on the shortcomings of the report we urge people to read the commentary by the panellists Jorge Bermudez, Winnie Byanyima and Shiba Phurailatpam (annex 1 to the report).
Demonstration at Department of Trade and Industry on 27th September
We repeat our call for the South African government to engage with this report at all levels and to adopt its recommendations. It is the people who are paying the price for government’s ongoing failure to reform our outdated patent laws. While we are aware that an inter-ministerial committee has been established to consider patent law reform, we remain concerned about the lack of buy-in from different government departments and their Ministers. This is a matter that needs to be dealt with at Cabinet level. Delays over the last ten years have shown that law reform that would ensure better access to medicines has not been a priority for government. This indifference from our elected leaders is unacceptable.
On Tuesday 27th September TAC, SECTION27 and partners will protest outside of the South African Department of Trade and Industry in Pretoria. We will ask Minister of Trade and Industry Rob Davies to explain to us why we are still waiting for law reform 15 years after the signing of the Doha Declaration. We will hand him a copy of the UN report, our comments on a Consultative Framework recently published by the Department of Trade and Industry, and a report from the Fix the Patent Laws campaign to be released that day outlining access challenges on a range of medicines in the country. We invite all concerned people to join us.
The struggle continues.
For media comment contact:
Lotti Rutter | TAC | lotti.rutter@tac.org.za | +27 81 818 8493
Umunyana Rugege | SECTION27 | rugege@section27.org.za | 083 458 5677
Johannesburg Declaration: http://tac.org.za/sites/default/files/Johannesburg%20Declaration%20.pdf
Video of picket at the Johannesburg UN High-Level panel hearings: https://www.youtube.com/watch?v=Lo1vNNxU_zQ
TAC made the following three submissions to the High Level Panel:
1.     A call on all developing countries to fully utilise all the safeguards available in the TRIPS agreement as clarified in the Doha Declaration to ensure public health is protected http://www.unsgaccessmeds.org/inbox/2016/2/28/lotti-rutter (Submission endorsed by AIDS Access Foundation, Thai Network of People Living with HIV/AIDS, FTA Watch, Delhi Network of Positive People (DNP+), ITPC-South Asia and  SECTION27)
2.      A proposal for linking intellectual property rights on pharmaceutical products to research mandates http://www.unsgaccessmeds.org/inbox/2016/2/27/marcus-low (Submission endorsed by Knowledge Ecology International and SECTION27)
3.     A call on the HLP to acknowledge the impact of trade pressure (through mechanisms like the United States 301 Watch List) on the use of TRIPS flexibilities and for the United Nations to do more to support developing countries in utilising TRIPS flexibilities https://highlevelpaneldevelopment.squarespace.com/inbox/2016/2/29/lotti-rutter   
We also endorsed the following five submissions:
4.     Amy Kapczyynski of the Yale Global Health Partnership on the right to health and access to medicines http://www.unsgaccessmeds.org/inbox/2016/2/28/amy-kapczynski
5.     James Love of Knowledge Ecology International on United Nations support for Global R&D agreements http://www.unsgaccessmeds.org/inbox/2016/2/29/james-love
6.     James Love of Knowledge Ecology International on measures that can be taken to increase the transparency of markets for medical products https://highlevelpaneldevelopment.squarespace.com/inbox/2016/2/29/james-lovec
7.     Professor Brook Baker of Health Global access project on radical reform of global and national intellectual property norms on medical technologies for all health needshttp://www.unsgaccessmeds.org/inbox/2016/2/26/z73kpodxk4jw96mhqe2tivq0sd1g3v
8.     Professor Brook Baker of Health Global access project on a compulsory licensing facility/consortium http://www.unsgaccessmeds.org/inbox/2016/2/27/brook-baker