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UK pharma strikes optimistic note as Brexit process begins

Says life science industry is accustomed to ‘uncertainty’ and can thrive in a post-EU Britain


With Article 50 now triggered, the tough job of negotiating Brexit gets underway amid a clamour of requests and comments from private and public enterprises alike.

All eyes are now on the preliminary response to the letter triggering Brexit - which European Council president Donald Tusk has said will be ready on Friday – and which expressed Prime Minister Theresa May's desire for a "constructive and respectful" negotiation process aimed at producing a "deep and special partnership" with the EU.

Highlighting the importance of economic and security cooperation, the PM's letter seeks "a bold and ambitious Free Trade Agreement" between the UK and the EU, which should be "of greater scope and ambition than any such agreement before it so that it covers sectors crucial to our linked economies such as financial services and network industries".

Industry eyes no doubt latched onto May emphasising the importance of managing "the evolution of our regulatory frameworks to maintain a fair and open trading environment".

The PM's letter strikes a much more conciliatory tone than earlier rhetoric coming out of the UK government that "no deal would be better than a bad deal", and comments from the UK life sciences industry indicate there is some degree of confidence that the sector can ride out the coming storm and perhaps even thrive in a post-EU environment.

Steve Bates, the BioIndustry Association's CEO, insists that the fundamental of UK bioscience remain strong describing the sector as a "dynamic, globally focused community, unfazed by new challenges and staffed by great management teams used to working with uncertainty and risk".

He warned against paying too much attention to "press speculation, bombast and rhetoric" during the two-year negotiation period, but said early agreement on issues like "the regulation of medicines, the regime to enable non-UK nationals to work and contribute to the UK life science ecosystem, trade, finance support, market and IP rules would be the best way to ensure speedy and continuing global inward investment into the UK and EU".

The BIA joined the Association of the British Pharmaceutical Industry (ABPI) in welcoming the UK government's positioning of the life science sector as one of 12 "negotiating priorities" for Article 50.

There is now consensus on the key issues affecting the industry said the ABPI, and CEO Mike Thompson said the organisation is "pleased with the pragmatic approach taken by government in preparing for Brexit negotiations".

"This has resulted in us making good progress in a number of complex areas including proposals for barrier free trade and the future of medicines regulation. We will now seek to secure the best possible deal for bringing innovative medicines to patients and protecting the future of the UK's world-leading pharmaceutical industry."

The European Federation of Pharmaceutical Industries and Associations (EFPIA) took a slightly more cautious tone, warning that the negotiations must ensure "minimal disruption to patients, healthcare systems and the research and development of new treatments" and not affect the alignment between the UK and EU regulatory and intellectual property (IP) systems as they apply to medicines.

"Supply chain operations are interconnected, which means that a diverse range of products including active pharmaceutical ingredients and R&D materials move back and forth throughout the Europe as part of the manufacturing process," said EFPIA, adding: "Any disruption could lead to delays in medicines reaching patients."

There were similar concerns from medical charity The Patients Association, which warned that the government "must be alive to both the risks and the opportunities of Brexit for patients, and avoid any errors that jeopardise health and care provision".

"Safeguarding the NHS and social care workforce is vital, in terms of continuing to bring in vital workers from abroad, and ensuring European professionals already here can remain – and wish to," said the charity's CEO Katherine Murphy.

"Availability of medicines will also be a vital issue for patients: it is not clear how we will replace the functions of the European Medicines Agency once we have left it; and there is a risk that pharmaceutical companies will prioritise selling their drugs in the larger market of the EU, only offering them to UK patients later," she warned.

The animal health sector also added its voice saying that the triggering of Article 50 "will undoubtedly engender a number of challenges for the veterinary medicines industry".

"Our main concern at this early stage is ensuring continued solutions for animal health and welfare and safe and sustainable food production," said IFAH-Europe secretary general Roxane Feller, who added there are a number of areas for immediate focus such as "avoiding legal and regulatory uncertainty [and] harmonising licensing systems for veterinary medicines".

The reality is now there will be something of an anti-climactic period as the other 27 members of the EU formulate a response to the trigger, with a meeting scheduled for April 29 to agree a joint position, and talks not expected to get underway until mid-May.

A draft European Council statement indicates that the first priority will be "to minimise the uncertainty caused by the decision of the UK for our citizens, businesses and member states", and that it will strive to find an agreement that will allow an orderly withdrawal.

"In the future we hope to have the UK as a close partner," it says, but adds: "Should the negotiations fail, we will make sure that the EU is ready for such an outcome even though we do not desire it."

Article by
Phil Taylor

30th March 2017

From: Regulatory



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