By Yannis Natsis @ynatsis Policy Coordinator, Universal Access & Affordable Medicines, EPHA
The much-anticipated report of the UN High Level Panel on Access to Medicines, convened by Secretary-General Ban Ki-Moon, was released on September 14. The report reaffirms that barriers to accessing medicines have become a worldwide challenge, facing countries irrespective of their GDP. The policy incoherence between the “justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies” was the starting point for the work of the esteemed panel. As a result, the key task of its 15 members – including GSK CEO Sir Andrew Witty & Cipla’s Yusuf Hamied, two leading industry representatives – was to address the misalignment between today’s patent-based profit-driven drug development models and public health priorities.
This is undoubtedly a landmark statement, despite the fact that this is a UN report with its innate constraints taking diplomatic sensitivities into account. It is an unprecedented political acknowledgement that affordable access to medicines has become a challenge across disease areas and in all countries. Even comparatively rich countries in Europe are struggling to provide access to life saving treatments because of exorbitant drug prices, as the Netherlands raised during their Presidency of the European Council earlier this year.
The report identifies the current inconsistency between intellectual property (IP) rights and public health objectives. It points to this inconsistency as the root cause of the high prices which block patients from getting the treatment they need and disincentivise the development of new medicines. In this respect, it reminds us that “IP rights are temporary, revocable, transferable privileges granted by states and can be suspended or revoked…when it is in the interest of the state or society”. The Panel calls for a new mix of incentives along with a binding global R&D Convention that delinks the cost of drug research and development from end prices.
The Panel’s report sets out recommendations to achieve independently verifiable transparency in the cost of medical R&D, clinical trials, pricing and patent information. It also emphasizes the role of public funding in the development of the health technology, including but not limited to, tax grants, incentives and credits.
In practice, the report offers an extra layer of protection to encourage governments to make use of their rights enshrined in the 2001 Doha Declaration and the public health-linked Trade-Related Aspects of Intellectual Property Rights (TRIPS) flexibilities agreement. For countries aspiring to use tools such as compulsory licenses this is welcome, for example Thailand and most recently Colombia who had been subject to intimidation efforts and threats of retaliation by the U.S. and the EU.
However, the polemical reactions to the Panel report from the U.S. State Department, the pharmaceutical industry, the U.S. Chamber of Commerce serve as a reminder not to underestimate the vested interests at stake who will oppose the momentum and this mandate for fundamental change. Nevertheless, the fact that the Panel included industry representatives amongst the experts and the clarity of their report means that the real issues at stake cannot be denied or brushed aside. It is now up to governments to follow up by ambitious implementation of the recommendations.
What does the EU say about all of this?
So far, the European Commission does not seem to have been paying much attention to the HLP procedure as exemplified by its very modest submission to the Panel. The Council of Health Ministers however took everyone by surprise and proved to be much more forward looking with the groundbreaking June 2016 Conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States. Health Ministers from across Europe have taken a critical stance on additional forms of patent protection and have raised the possibility of amending the regulatory framework putting the abuse of the orphan drugs legislation in the spotlight.
Both the Panel report and the Council Conclusions share to a great extent the same understanding of the real barriers to access to medicines which need to be dismantled, namely market failures, information asymmetries, governance issues, the lack of enforcement of competition law, high prices as barriers, disproportionality of incentives and rewards, and today’s pharmaceutical business strategies among others. The two documents also outline a lot of the same recommendations such as equitable licensing, fair return on investment for publicly funded research and the review of the IP-related incentives.
So, both the UN High Level Panel and the Council of European Ministers of Health have sounded the alarm loud and clear. The Panel’s recommendations come at an excellent time as the European Commission is currently reflecting on next steps following the Council Conclusions and must take the UN report into account. The Commission has been tasked by Ministers to conduct the “evidence based analysis of the impact of the incentives on innovation, as well as on the availability, inter alia supply shortages and deferred or missed market launches, and accessibility of medicinal products, including high priced essential medicinal products as well as the availability of generic medicinal products”.
No more lip service
If decisive action is not undertaken now, the future of our health and health systems is at stake. European governments and the Commission must respond to today’s unparalleled political momentum with sensible and proportionate proposals, which will effectively tackle the barriers to access, including excessive and unjustified prices. The pharmaceutical industry, one of the most profitable and influential business sectors of recent decades, will of course rally against proposals to change the regulatory status quo from which it has profited enormously. But given the scale and urgency of the crisis in access to medicines facing every patient, every hospital, every government and every country, no proposal should be considered taboo or off limits. It is up to policymakers, including those in Europe, to set the new rules of the game to ensure that our health is the real winner.