WASHINGTON, DC (September 19, 2017) – The Association for Accessible Medicines, the Canadian Generic Pharmaceutical Association and the Mexican Association of Generic Medicines are urging their three governments not to raise drug prices for patients by extending monopolies for brand name medicines and biologics under a renegotiated North American Trade Agreement (NAFTA).
In a letter to the assistant United States Trade Representative for the Western Hemisphere and chief NAFTA negotiators from Canada and Mexico, association presidents Chester “Chip” Davis, Jr., Jim Keon and Dr. Rafael E. Maciel Martinez encouraged negotiators to ensure that NAFTA’s intellectual property rights chapter explicitly affirm the balance between innovation and affordability of medicines, and avoid imposing additional onerous barriers to affordable medicines that would increase drug prices and delay access to patients. These include measures that would expand monopolies held by brand name drug companies through longer marketing or data exclusivity periods, as well as mandates to extend a patent term based on delays in granting the patent or obtaining marketing approval.
Davis, McKeon and Martinez note that including a new provision in NAFTA to mandate biologic drug exclusivity – above and beyond the protections already provided by voluminous patents – will harm the growing biosimilar industry, which aims to provide price competition to the most expensive biological drugs and allow patients to benefit from affordable biological medicines.
Davis stated, “As President Trump and FDA Commissioner Gottlieb search for ways to lower prescription drug costs by enhancing generic drug competition and streamlining the biosimilar approval process, increasing branded biologic exclusivity in NAFTA would damage the growing U.S. biosimilar industry and harm North American patients who seek safe, effective, and affordable alternatives to costly biologic drugs.”
The three associations also encourage the NAFTA negotiators to enhance the intellectual property provisions of NAFTA to incorporate provisions that facilitate the development of affordable generic and biologic medicines in North America, including those that would:
- Require a research (Bolar) exception to facilitate timely access to generic and biosimilar competition once patents have expired,
- Require patent transparency and
- Enhance initial generic drug and biosimilar competition.
The three organizations also assert an updated NAFTA can play an important role in increasing the efficiency of the North American pharmaceutical market by incorporating provisions that would streamline the regulatory process, including through regulatory harmonization and recognition where appropriate. A mutual recognition agreement on inspections between Canada and the United States– similar to the agreement reached between the United States and the European Union – is a particular priority.