In 2007 a meeting on Global Pharmaceutical Regulation was convened in Tallahassee, Florida to discuss major issues then affecting innovation, access and the regulatory environment for medicines. At that time, scaling up access to treatments for HIV-AIDS around the world remained a major concern, including the potential impact of new trade agreements and financing requirements. In addition, participants expressed concerns regarding a generally slow pace of innovation, and problems associated with elevated pricing, particularly for low and middle-income countries. Assuring a global system of quality control in manufacturing and distribution was another major topic of discussion. A co-authored book by Frederick Abbott and Graham Dukes, Global Pharmaceutical Policy (Elgar 2009), was one result of that meeting, reflecting on a number of themes that had been developed.
A great deal has transpired over the past decade in the general field of pharmaceuticals. Issues surrounding global health security, including methodologies for developing and introducing vaccines and treatments for epidemics, have increasingly attracted attention. As industry and the medical community have increasingly focused on the development of biologic medicines (a substantial subject of the 2009 book), issues surrounding innovation, pricing and pathways for follow-on biologics require examination. The emergence of strong bio-pharmaceutical sectors in countries of Asia, including China and India, reflects some shift of R&D focus from the United States and Europe toward Asia. The United Nations Secretary General formed a High Level Panel on Access to Medicines which considered a large number of submissions regarding potential mechanisms for stimulating innovation while facilitating affordable access to medicines. The submissions, public and private forums at the UN High Level Panel on Access to Medicines identified a range of options and issues for future consideration, some of which were ultimately addressed in the Report of the Panel.
Within this framework it is difficult to ignore the tectonic shift in the political landscape in the United States, although at this stage the practical consequences from the standpoint of innovation and access in the pharmaceutical sector are highly uncertain. Among the developments:
1. A growing number of members of the U.S. Congress are paying close attention to pharmaceutical prices and demanding greater transparency and accountability. Though it is exceedingly difficult to predict what the consequence of this attention may be, the level of attention to pharmaceutical pricing is higher than any time since the early 1950s. Relating to this, the President has made a number of pronouncements regarding pharmaceutical prices, including the potential for direct government price negotiation with the industry.
2. At the outset of a meeting with pharmaceutical company executives at the White House on January 31, 2017, the President expressed a strong interest in moving pharmaceutical production back to the United States, and in dramatically reducing federal regulation affecting the pharmaceutical industry. With respect to de-regulation, subsequent references have been made to accelerating the approval of new drugs, and introducing more competition in the pharmaceutical sector.
3. A budget proposal from the President included a substantial cut back in funding for the National Institutes of Health. In addition, proposed budget cutbacks for the State Department and for funding of foreign aid in general raise question whether the United States will maintain its commitment to programs such as PEPFAR, a withdrawal from which would have dramatic consequences for access in Africa in particular.
4. After the expenditure of substantial political capital in securing more extensive market protection for pharmaceuticals (e.g., an eight year term of market exclusivity for biologic products), the new Administration withdrew from the Transpacific Partnership Agreement that it had previously signed. Yet, there has been little indication from the new Administration regarding what might be intended as a policy substitute. Given the pronouncements from various Administration spokespeople regarding deficiencies in protection of US intellectual property overseas, it seems unlikely that next steps will involve a reduction in US-demands for high levels of pharmaceutical (including biologics) protection overseas, although the corresponding expressed interest in reducing pharmaceutical prices leaves some room for question.
It is within this landscape that we convene another meeting in Tallahassee on Global Pharmaceutical Regulation 2017 to discuss and identify the critical issues facing policymakers, as well as potential mechanisms for creating the optimal outcomes for patients.