Geneva: The United Nations High Level Panel on Access to Medicines (UNHLP) has urged governments to use “flexibilities” accorded to them in the World Trade Organization’s TRIPS agreement to ensure that patents for life-saving drugs are only awarded for “genuine innovation”.
Faced with intense political and economic pressure from western governments and their pharmaceutical companies, governments in developing and poorest countries seemed unable to use “flexibilities” provided in the WTO’s Trade-Related Intellectual Property Rights agreement, the panel noted.
TRIPS flexibilities involve “the freedom to determine patentability criteria” and include concepts such as “novelty”, “incentive step” and “industrial applicability”.
Further, the flexibilities enable the governments to determine the terms upon which “compulsory licences” are issued to the big pharma companies for “securing the availability and affordability of health technologies”.
India had rejected the patent for the Novartis cancer drug Gleevec on the grounds that inventions are patentable only if they differ significantly in properties with regard to efficacy under the 3d provision in the amended Indian Patent Act.
The amended Indian Patent Act also enabled the patent authorities to deny the evergreening of patents by powerful pharmaceutical companies to extend the period of patent protection through minor and insignificant changes of the compound.
Subsequently, India came under intense pressure from the US and other major industrialized countries to drop the 3d provision.
Recently, the government announced IPR policy guidelines in the face of intense lobbying by powerful pharmaceutical companies in major industrialized countries.
The panel warned that “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,” the panel said. It also cautioned governments in developing countries that “the use of TRIPS flexibilities may also be impeded by the proliferation of bilateral and regional free trade agreements containing TRIPS-plus provisions”.
At a time when research and development of health technology is largely public-funded in major industrialized countries, particularly in the US, it said, “public funding agencies should strongly encourage patenting and licensing practices that benefit public health, including the use of non-exclusive licenses, the donation of intellectual property rights, participation in public sector patent pools and other mechanisms that maximize innovation while promoting access.”
It called for “effective accountability frameworks” to ensure that pharmaceutical companies and other stakeholders are “responsible for the impact of their decisions and actions on innovation and access to health technologies”.
The panel urged WTO members to “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 the best interests of the public health of the country and its inhabitants”.
These include amending laws to curtail the evergreening of patents and awarding patents only when genuine innovation has occurred.
The panel asked governments to “adopt and implement legislation that facilitates the issuance of compulsory licences” for legitimate public health needs, and particularly with regard to essential medicines. It emphasized that “governments and private sector must refrain from explicit or implicit threats, tactics or strategies that undermine the right of WTO members to use TRIPS flexibilities”.
The panel wants WTO members to “register complaints against undue political and economic pressure which includes taking punitive measures against offending WTO members”.
More important, “governments engage in bilateral and regional trade and investment treaties should ensure that these agreements do not include provisions that interfere with their obligations to fulfil the right to health. As a first step, they must undertake public health assessments to verify that increased trade and economic benefits are not endangering or impeding the human rights and public health obligations of the nation and its people before entering into commitments.”
Governments, according to the panel’s recommendations on R&D, production, and pricing and distribution of health technologies, “should require manufacturers and distributors of health technologies [pharmaceutical companies] 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
The panel wants governments to increase their current levels of investment in health technology innovation to address unmet needs and also establish and maintain publicly accessible databases with patent information status and data on medicines and vaccines.
The term evergreening implies patenting or marketing strategies to extend the period of patent protection or effective period of market exclusivity, which are considered unjustifiable and therefore abusive.
Public health groups such as MSF have warned that if India changes its IPR provisions under pressure from powerful governments, the generic pharmaceutical companies will be unable to supply affordable medicines.
After scuttling globally beneficial obligations for sharing the latest technologies to combat climate change in the recent Paris agreement, the powerful US industry and business lobbies had lobbied to undermine the UNHLP.
In a letter addressed to senator Orrin Hatch, the chair for the US Senate Committee on Finance several months ago, six leading American industry and business lobbies demanded an “effective inter-agency approach” which was adopted by the US delegation in the Paris climate talks to other UN initiatives, particularly the UN High Level Panel on Access to Medicines.
The six American lobbies include the Biotechnology Innovation Organization (BIO), National Association of Manufacturers (NAM), National Foreign Trade Council (NFTC), the Pharmaceutical Research and Manufacturers of America (PhRMA), the US Chamber of Commerce (the Chamber), and the United States Council for International Business (USCIB).
They cited the “effective inter-agency approach” under the leadership of the US State Department to “secure a final UNFCCC (UN Framework Convention on Climate Change) text that does not mention IP (intellectual property) and thus removes uncertainty that could have discouraged investments by the US companies in clean technology.”
The US lobbies maintained that “significant challenges to IP still remain in the Paris Agreement’s implementation and subsequent negotiations -- especially those related to the technology development and transfer chapter.”