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GPhA and EGA Urge TTIP Negotiators to Adopt Sensible Measures to Streamline Drug Development and Approval Processes

 Contact:

Claire Sheahan

202.249.7110

Generic Industry Calls for Thoughtful Changes to Speed Medicines to Patients

WASHINGTON, DC (April 7, 2014) — In a joint letter sent April 3rd to the European Commission and the Office of the US Trade Representative, the Generic Pharmaceutical Association (GPhA) and European Generic medicines Association (EGA) recommended that Transatlantic Trade and Investment Partnership (TTIP) negotiators pursue a strategy of regulatory convergence. The letter focuses on specific ways that trade agreements can remove duplicative processes.

“EGA and GPhA believe that adopting these measures in TTIP, while rejecting attempts to harmonize intellectual property regimes, would create jobs, generate revenues and ensure access to medicines where they are needed, while contributing significantly to the sustainability of our health care systems,” states the letter, signed by Ralph G. Neas, President and CEO of GPhA, and Adrian van den Hoven, Director General, EGA.

The letter reiterated five key recommendations shared by GPhA and EGA in an earlier presentation in Brussels during the fourth round of TTIP negotiations. They are:

1. Enhance existing cooperation between the European Medicines Agency and the Food and Drug Administration on the convergence of biosimilar development pathways. By adopting existing EU guidelines and US guidance, the biosimilar medicines industries of the EU and US would be able to substantially increase patient access to high quality biopharmaceuticals. It would also boost industrial competitiveness and support the sustainability of healthcare systems, while promoting the global use of the highest approval standards.

2. Implement a single development and approval pathway for generics. Adopting EU guidelines and US guidance for the single development of generic medicines would avoid unnecessary and costly redundancy, ensure faster patient access to pharmaceuticals in both markets and help to avoid the unethical duplication of clinical studies. The cost savings, particularly for smaller or mid-size generic manufacturers, would be substantial.

3. Mutually recognize good manufacturing practice (GMP) inspections. Generic pharmaceutical manufacturers and active pharmaceutical ingredient (API) manufacturers can benefit from enhancing cooperation between regulatory agencies. This would ensure compliance globally and free up resources for European and American inspectors to visit more manufacturing sites in countries outside the EU and US. Additionally, mutual recognition would bring relief to manufacturers, which put substantial resources into hosting inspections.

4. Adopt advanced manufacturing during patent term extension period. Advanced manufacturing would enable product launches immediately after patent expiry in markets where there is no patent term extension. This would allow US and EU manufacturers to compete with companies from markets that do not have patent extension provisions, particularly emerging markets.

5. Reject proposals to harmonize US and EU intellectual property regimes. Increasing patent protection is unnecessary and would have adverse social and economic impact. Each region has its own robust patent law which adequately protects patent-holders.

To read the letter and learn more about GPhA TTIP recommendations, click here.


About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry.

Generic pharmaceuticals fill 84 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending, saving the health system nearly $200 billion annually. Additional information is available at www.gphaonline.org. Follow us on twitter: @gpha.