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Response to the Secretary of State for Health’s letter to medicines Marketing Authorisation Holders


In response to the Secretary of State for Health’s letter to medicines Marketing Authorisation Holders, Warwick Smith, Director General of the British Generic Manufacturers Association (BGMA) and the British Biosimilars Association (BBA), said: "We have been discussing with the Government for some time how to ensure that the medicines supply chain continues to operate effectively in the event of a no-deal Brexit. Clearly, the complex nature of the manufacture and supply of medicines in Europe means that they and their constituent parts may cross many borders before reaching patients. A deal between the UK and the EU27 to maintain these free flows is obviously the only way to ensure that the supply of medicines is not disrupted.


“The Government has shown a welcome determination to act pragmatically on the regulation of medicines to ensure their continued supply to British patients. This is something to which they and we, as the generic and biosimilar medicines industries, are committed. But the UK Government alone cannot ensure that there are no delays at the UK’s external borders in the event of a no-deal Brexit. So it is wise for the Government to plan for appropriate stockpiling of medicines to deal with possible delays.


“We particularly welcome the fact that the Government is putting in place planning to enable additional stocks of medicines held by manufacturers in the UK to be matched with available warehousing space. Warehousing approved for pharmaceutical use is a limited resource, and medicines manufacturers operating independently cannot be expected to ensure that it is shared out and matched to demand. Only the Government can do this, and we welcome the fact that planning is well underway.


“Of course, this is making the best of a bad job. No-one wants to see delays at the UK’s borders risking the supply of medicines to patients that the Secretary of State’s proposals are designed to cope with. As we have consistently said, what is needed to ensure the supply of medicines to British patients is an agreement between the UK and the EU27 to allow the free flow of medicines and their components. Ideally, we want the UK to remain part of the European medicines regulatory environment, or more pragmatically a mutual recognition agreement to be agreed quickly.


“We again call on the UK’s and the EU’s negotiators to recognise the unique position of medicines, which are not just another good on the market, but needed lifesaving treatments, and urgently to agree measures to ensure their continued free flow to patients on both sides of the Channel.”