The Transatlantic Trade and Investment Partnership (TTIP) negotiations pose serious risks to Europeans’ access to medicines and affordable healthcare. TTIP is likely to help entrench a broken medical innovation system rather than seize today’s opportunities to advance medical innovation and affordable access to medicines for all. Pharmaceutical corporations charge European Union (EU) Member States and the United States (U.S.) increasingly higher prices for medicines.
EU Member States and the U.S. are facing a looming access to medicines crisis as they struggle to afford new, patented, high-priced medicines. At the same time, since the 1980s, no new truly valuable antibiotics have reached the market.
Despite stringent intellectual property (IP) rules and continued lengthening market monopolies, there has been a striking lack of medical innovation. EU Member States have therefore rightly questioned whether excessive IP rights and additional market monopolies, which are now at the disposal of the pharmaceutical industry, function well as drivers for pharmaceutical innovation in their 2016 Council Conclusions.
The Dutch Health Minister leading these Conclusions has called for a new balance between IP protection and affordable and sustainable access to medicines, prioritizing the exploration of alternative research and development (R&D) models. Leading public health institutions, academics and the World Health Organization (WHO) have questioned the current monopoly-driven incentive model for biomedical innovation for more than a decade, while exploring alternatives that focus on sharing knowledge rather than granting market monopolies.
Most recently, the UN High Level Panel on Access to Medicines has also called for investment in alternative models of innovation. At the same time, EU Member States are calling for more effective pricing and reimbursement strategies to counter pharmaceutical companies’ monopoly pricing strategies and ensure sustainable access to medicines. TTIP could impede change towards affordability, needs-driven innovation and alternative incentive structures.
TTIP may add to existing monopoly protections for medicines; reinforce the current trend of industry claiming trade secret protection to limit access to crucial information on medicines’ safety, efficacy and development; reign in the freedom of national governments to make decisions on pricing and reimbursement to ensure affordability; and establish global standards that are harmful for developing countries.
In this paper, we will first discuss how the argument for strong monopoly protections as a driver for pharmaceutical innovation is seriously flawed. Then, based on key EU, U.S. and pharma position and proposal documents on TTIP, we critically assess how:
• TTIP may lock in or even expand monopolistic intellectual property rules.
• TTIP runs the risk of limiting public access to information about the medicines we take.
• TTIP may constrain a government’s effective medicines pricing and reimbursement policies.
• TTIP could enable structural pharmaceutical industry mingling in domestic & EU medicines and IP policies.
• TTIP’s standards would harm access to medicines in developing countries.