News about GMP/cGMP

22.05.2018

Post-Brexit Agreement for UK's Pharmaceutical Industry Needed

The UK government must secure a post-Brexit deal for the pharmaceutical industry that ensures the closest possible regulatory alignment with the EU and the minimum border friction possible or risk harming patients and seeing the pharma sector losing its status as a world leader, say the Business, Energy and Industrial Strategy Committee of the UK parliament.

The Committee’s report, ‘The impact of Brexit on the pharmaceutical sector’ finds that leaving the EU without an agreement for the industry would diminish access to markets, including £11.9billion of exports and to more than 446million potential patients and consumers in the EU. British patients’ access to medicines would also be at risk, with nearly three-quarters of pharmaceutical imports coming from the EU.

Drug costs could be significantly impacted

The report concludes that the prospect of regulatory divergence from the European Medicines Agency (EMA) is the deepest concern for the industry, which would mean pharmaceutical companies needing to duplicate their facilities and roles across the UK and EU. Drug costs could be significantly impacted. A separate regime could impose extra costs of £45,000 for each new product released, making the UK an unattractive market for new and innovative medicines. While the Government has indicated its desire for continued cooperation, the Committee calls for a continued form of membership of the EMA as a priority, and recommends that the Government seek to retain a presence for the EMA in the UK after its relocation to Amsterdam.