Trading between the European Union and the United States Atlantic has a long and successful tradition. Beyond the general goals of a trade agreement, such as increasing wealth and better market access on both sides of the Atlantic, TTIP could also target to resolve specific hurdles the BioPharma industry faces when operating across the Atlantic.
MassBio, the Biotechnology Industry Organization (BIO), the British Embassy and the British Consulate General hosted in collaboration an event to discuss the Trans Atlantic Trade and Investment Partnership (TTIP) with the perspective of the US/EU biopharmaceutical industry. Speakers from the Office of the United States Trade Representative (USTR), US Food & Drug Administration (FDA), the European Union (EU), and the European Medicines Agency (EMA) met representatives from US and European biopharmaceutical companies. The panels discussed the current state of the TTIP negotiations and existing regulatory hurdles in the biopharmaceutical sector.
TTIP – a path of convergence for the US/EU BioPharma industry?
Many members of the BioPharma industry operate globally which requires adjustment to country-specific policies regarding good manufacturing practice (GMP), market access and reimbursement. Differences in GMP regulations represent one major obstacle for bringing new drugs into the respective market and demonstrate the potential for harmonization under TTIP. It was emphasized that the overall goal of TTIP was to use existing laws and to align these in an implementable way.
TTIP could combine health and trade on equal terms. Two examples specific for the BioPharma industry were discussed.
- Mutual recognition agreements of GMP inspections would allow the focus of inspection efforts on risky operations instead of checking the same plant by US and EU inspectors.
- The possibility to seek parallel scientific advice for products in the development phase would enable the BioPharma companies to design clinical trials most effectively.
Both examples aim on cutting costs while improving patient safety and ensuring high quality standards.
Good ideas come from all different places. In order to target the obstacles experienced by the BioPharma industry, stakeholders need to come forward to suggest objectives and to raise awareness for potential solutions to resolve unnecessary bureaucratic complexity.
What’s next? Follow the ongoing TTIP negotiations via EU and US resources!
- The 11th round of TTIP negotiations was held 19-23 October in Miami USA and the outcomes are presented HERE.
- The Office of the Unites States Trade Representative provides updates on current negotiation rounds, fact sheets and press releases HERE.