Pharma Groups Welcome UK Position on Goods, Lobby for Government Investment

The Center for Biosimilars Staff

The United Kingdom (UK) has issued a position paper on ensuring a smooth economic transition from the European Union (EU) in relationship to the availability of goods, including pharmaceuticals.

The United Kingdom (UK) has issued a position paper on ensuring a smooth economic transition from the European Union (EU) in relationship to the availability of goods, including pharmaceuticals.

The paper outlines the UK’s 4 guiding principles that it will bring into its Brexit negotiations:

  • Goods placed on the single market before the UK’s withdrawal from the EU should continue to circulate freely in both jurisdictions. The paper indicates that these products’ makers should not be required to change any labeling or to receive any new approvals.
  • In cases in which businesses have undertaken compliance activities before the UK’s withdrawal, businesses should not have to replicate their efforts in order to keep goods on either market. The UK proposes that the regulatory bodies that have assessed products that are already on the market continue to address ongoing regulatory obligations for the duration of a product’s life. The results of regulatory actions should be recognized in both markets.
  • An agreement between the UK and EU should include continued oversight of goods to assist with market surveillance and the traceability of products.
  • Where goods are supplied with services, there should be no restriction on provision of services that could undermine the agreement on goods. The UK hopes to ensure that qualifications of professionals who deliver services linked to goods are recognized in both the UK and EU.

UK pharmaceutical trade groups praised the government’s proposals; CEO of the Association of the British Pharmaceutical Industry, Virginia Acha, DPhil, said, “We welcome this paper’s pragmatic approach, which provides a constructive starting point for arrangements that aim to minimize disruption to vital safety and monitoring processes for medicines and avoid any negative impact to medicines supply. As soon as the negotiations resume, we urge the EU and UK to discuss this issue with Europe’s patients front of mind.”

As the Brexit deadline of March 2019 draws close, trade groups are also lobbying for the UK to make new investments in pharmaceuticals in order to decrease the UK’s dependency on foreign markets. The Medicines Manufacturing Industry Partnership has issued a report stating that, because the UK relies on imports for many components of its pharmaceuticals, “we are less self-sufficient and more vulnerable to supply shortages, and we ultimately lose high-value jobs and manufacturing know-how and skills.”

The report calls for the establishment of national “Centres of Excellence” that would develop manufacturing capabilities to ensure the supply of drugs, create an open-access facility with the capacity to manufacture patient-ready medicines, develop packaging and delivery-device technology, and support innovative manufacturing of advanced therapies. These initiatives are estimated to cost the UK government £140 million (approximately $179.5 million).

The report’s authors say that the development of the UK’s pharmaceuticals industry “can only happen if the various stakeholders work together and have a clear end goal, which has to be driven through by anchoring the UK as the country for all medicines innovation and manufacturing investment.”