Written by Elizabeth Wiley, MD, JD, member NPA FDA Taskforce
Over the last five years, a new generation of “mega” trade agreement negotiations have emerged that seek to establish a new global trade governance framework with far-reaching potential implications for health and health care. The size, scope and lack of transparency of these negotiations are unprecedented.
Launched in 2010, Trans Pacific Partnership (TPP) includes twelve negotiating parties: Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, United States and Vietnam. The Transatlantic Trade & Investment Partnership (TTIP) negotiations include the European Union and United States. Between the TPP and TTIP, forty countries representing more than 60% of the global gross domestic product (GDP) are involved in current negotiations, and the Obama Administration has signaled that these agreements will serve as a model for all future agreements. Thus, TPP and TTIP negotiations will likely have truly global ramifications.
So why should physicians care about trade negotiations?
If successful, these agreements could significantly reshape the environment in which we, as physicians, serve patients and practice medicine. On a truly global scale, these agreements may affect:
- intellectual property and access to medicines, biologics and medical devices;
- prevention and control of noncommunicable diseases including regulation of tobacco, alcohol and obesogenic food/beverages;
- drug safety including clinical trial data transparency;
- health care services;
- environmental protection;
- food safety and supply;
- environmental and occupational health; and
- education including medical education.
To date, TPP and TTIP negotiations are conducted largely in secret with disparate access to draft texts and negotiators afforded to industry through US Trade Representative (USTR) Advisory Committees. Draft texts have been leaked for chapters of both agreements and paint a troubling picture of where negotiations are headed. The lack of transparency in negotiations has made advocacy and engagement by public health and other civil society groups challenging.
Access to Medicines
Leaked draft texts of TPP and TTIP suggest that these agreements may include aggressive TRIPS-plus (http://www.msfaccess.org/content/trips-trips-plus-and-doha )(-plus) intellectual property provisions that could have devastating effects on the affordability and accessibility of medications. A recent UNITAID report described how such provisions would prevent generic entry into the market, resulting in higher drug costs. Of particular concern are harmful provisions that would:
- Require patent linkage that would delay approval of generic drugs
- Allow “evergreening,” or extensions of patent protections for minor modifications of existing drugs
- Protect extended data/market exclusivity for drugs and establish lengthy data exclusivity protections biologics
- Extend patent protection for patent examination/review processes
- Prevent clinical trial data transparency
- Use transition periods to leverage support for more unsavory IP protections
A related concern is ensuring that an exception for the patenting of diagnostic, therapeutic and surgical techniques, similar to 35 USC 287(c), in any agreement. Such an exception is essential to preventing potential liability for patent infringement for health professionals performing procedures.
Investor State Dispute Settlement (ISDS)
Of particular concern is the possible inclusion of a broad investor-state dispute settlement (ISDS) mechanism in these agreements. ISDS provides a way for investors to bring claims against governments and seek compensation. ISDS cases are generally adjudicated by panels of private corporate attorneys with little transparency. When incorporated into much smaller scale trade agreements, these provisions have been used to challenge successful, evidence-based public health initiatives such as cigarette plain-packaging. ISDS has also been used by pharmaceutical companies to enforce patent protections and prevent generic drugs from entering the market. More than half of ISDS cases are either settled or decided in favor of the investor. Moreover, there is concern that the mere availability of ISDS may deter governments from adopting policies to protect health.
What can physicians do to ensure that the TPP and TTIP advance rather than undermine health and access to care?
Given the potential implications of these trade agreements on health and health care services, it is critical that we, as physicians, engage in negotiations and with law-makers. NPA recently signed on to a letter with many other organizations expressing concern about potential implications of intellectual property and ISDS provisions on access to medicines. As TPP and TTIP negotiations continue, look for more NPA trade and health advocacy activities and opportunities.
Interested in getting involved in NPA trade & health advocacy?
Email Liz Wiley at firstname.lastname@example.org.
Public Citizen (TPP)
Public Citizen (TTIP)
Knowledge Ecology International (TPP/TTIP)
CPAH Public Health Voice in Trade Policy Campaign
Health Action International (TTIP)
Trans Atlantic Consumer Dialogue (TTIP)
Greens/European Free Alliance (TTIP)
AFL-CIO & ETUC Joint Declaration (TTIP)