The UN Secretary General’s High-level Panel on Access to Medicines published its final report on 14 September 2016.
It took just two days for the US State Department to dismiss the report in a strongly-worded rebuke.
The Panel’s recommendations cover a wide area, including countries’ use of the flexibilities contained in TRIPS [the World Trade Organisation’s Trade-Related Aspects of Intellectual Property Rights Agreement] and TRIPS-plus provisions, incentives for research and development of health technologies, and global governance arrangements for R&D, production, pricing and distribution of medicines and health technologies.
The UN report took place against the background of efforts by US pharmaceutical companies to strengthen IP protection for medicines, including through the (now apparently very dead) Trans Pacific Partnership Agreement.
The Panel, which included Sydney Law School alumnus and former High Court Justice Michael Kirby, was an eminent but mixed group ranging from grassroots HIV treatment activists, former politicians, academics and senior executives of pharmaceutical firms.
Glancing over the biographies of members, you get the feeling that finding a consensus was always going to be a challenge.
Half the Panel members wrote additional commentaries to the Panel’s report, criticising the report for making dubious and unrealistic assumptions, or alternatively, for failing to adopt bolder and more visionary proposals on financing, IP and access (pp 54-63).
Regrettably, the Panel’s report, like the appointment of the Panel itself, has been ignored by Australia’s media.
Australians live in a bubble, protected by the Pharmaceutical Benefits Scheme (PBS) from experiencing the reality of real-world prices for essential medicines.
Under the PBS, patients pay a maximum of $38.30 for medicines listed on the PBS. “Concessional patients” ie those who hold a pensioner concession, seniors health care or other concession card, pay only $6.20.
Unfortunately, Australia’s much-loved safety net for pharmaceuticals leads to lack of interest in this most pressing of global health issues: how to increase access to medicines at prices that are affordable to those who need them, while ensuring incentives exist for future R&D in health technologies.
Key issues and recommendations
A key argument in the Panel report is that there is an incoherency and imbalance between the right to health and the rules and practice of international trade and intellectual property protection.
For example, while IP rights are enforced by dispute resolution provisions found in WTO agreements, and in bilateral and multilateral free trade and investment agreements, the accountability mechanisms for human rights, including the human right to health, lack precision, legal weight and enforceability (p 8).
The Panel referred to the proliferation of “TRIPS-plus” free trade agreements that require countries to dispense with the flexibilities in TRIPS (see pp 24-25), writing 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” (p 8).
The Panel report encourages countries to continue to make full use of TRIPS flexibilities in the spirit of the Doha Declaration, curtailing the evergreening of patents and ensuring that legislative criteria for the award of patents only reward genuine innovations.
The Panel encourages countries to adopt legislation authorising the issuing of compulsory licences, particularly in order to ensure affordable supply of essential medicines.
The Panel also encourages universities and research organisations that hold patents for inventions developed with public funds to prioritise public health objectives over financial returns, including by issuing non-exclusive licences, and participating in public sector patent pools.
The Panel urged governments to review the access to medicines situation in their own countries in light of human rights principles, ensuring that civil society is given the support it needs to submit shadow reports. According to the Panel, national policy on R&D should be coordinated by an inter-ministerial body to ensure coherence.
Similarly, the Panel recommended that the UN Secretary-General should establish an inter-agency taskforce on health technology innovation and access for the duration of the Sustainable Development Goals (2015-2030). The Taskforce would oversee the implementation of the recommendations of the High-level Panel and would report annually to the UN Secretary-General.
The Panel saw transparency as a vital accountability mechanism, urging private sector companies to “have a publicly available policy on their contribution to improving access to health technologies”. The policy should set out timeframes, reporting procedures and lines of accountability, including board-level responsibilities for improving access to health technologies (p 11).
Two further interesting recommendations were that national governments should require manufacturers and distributors of health technologies to disclose commercial in-confidence information to drug regulatory and procurement authorities. This should include the costs of R&D, production, marketing and distribution of the health technology, as well as the existence of any public funding received by the company during the process of development.
Secondly, the Panel recommended that the World Health Organisation should maintain an accessible, global database showing the prices of patented and generic medicines (and biosimilars) in the public and private sectors of all countries where the medicines are registered.
State Department’s response
In its rebuff to the Panel’s report, the State Department said:
We believe that we can both increase access to medicines and support innovation for the development of new and improved drugs for the world’s most critical health challenges. Indeed, there can be no access to drugs that have not been developed: support for innovation is essential.
No one disputes that the costs of investment in new health technologies can be substantial.
However, the UN Panel pointed to the complexity of the challenge. In some cases, the problem is that the market for diseases that affect few patients, or disproportionately affect the citizens of poorer countries, is simply inadequate to incentivise the necessary investment.
In 2014, 1.7 billion people in 185 countries were living with a neglected tropical disease. These diseases account for around 12% of the global burden of disease, yet over the period 2000-2011 only 4% of therapeutic products registered by the European Medicines Agency and the US Food and Drug Administration were for these diseases.
Similarly, antimicrobial resistance is a slowly mounting crisis, yet “only one novel class of antibiotics has been developed in the past 40 years” (p 14).
This state of affairs suggests that it is an over-simplification to simply assert that the answer lies in countries ratcheting up their IP protections in the hope that market forces will fix the problem.
One doesn’t need to deny the value of patent rights and incentives to nevertheless conclude that the system is broken.
It’s impossible to conclude otherwise when millions of the world’s citizens lack the safety net of a PBS, and where access to the medicine they need at real-world prices overwhelms their productive capability.
A substantial literature illustrates that essential medicines remain unaffordable for many people, in many countries of the world; see, for example here, and here.
Are you interested in studying health law at Sydney Law School? You do not need a background in law to do so. Sydney Law School offers a Graduate Diploma and a Masters degree in health law that is open to qualified applicants. Click here for further details.
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