The winner of the December 2019 UK’s general elections, PM Boris Johnson, is rapidly proceeding to finally make the Brexit become true on 31 January 2020; starting from this date, the negotiation period will start to find new trade agreements with the European Union, a process that should close by the end of 2020. June shall be a critical month, with an already planned summit with EU27s to monitor progress and to leave the UK the last chance to ask for an extension of the transition period (read more on the due schedule for 2020 on the Financial Times). Should the final deal not be reached by 31 December 2020, the hard-Brexit would finally occur.
The priorities for the negotiations
The Brexit Health Alliance (BHA) published a briefing document to highlight its priority areas for the incoming negotiations between the UK and the EU, in order to safeguard the interests of patients across the two sides of the Channel.
The Alliance – that includes the NHS and several industrial, scientific and academic associations – asks for a close cooperative relationship with the EU across trade in medicines and medical devices, health security and research. This approach is considered by BHA the best way to pursue the general goal of patient protection.
Detailed targets to be kept in mind by negotiators include the alignment of regulations and customs arrangements to maintain availability of safe medicines and medical devices both in UK and EU. BHA also expects the UK regulatory agency MHRA may continue its participation in the European Medicines Agency and other regulatory networks and databases.
The preservation of reciprocal healthcare arrangements is considered important to ensure the simple and safe access to healthcare for travellers from UK and EU, while a full UK participation in European research programmes (including Horizon Europe) and a full researcher mobility would be important to support innovation. Alignment on pre-competitive research regulation, including the fullest UK cooperation on clinical trials and participation in European Reference Networks, are other requests advanced by the Briefing document, as well as a continued collaboration and data sharing on health security.
The comments on the results of the general elections
The Association of the British Pharmaceutical Industry (ABPI) welcomed positively the results of the general elections, as Boris Johnson’s electoral programme included strong commitments to improve the availability of new medicines to NHS patients, the uptake of vaccines, and to place life sciences at the centre of an innovation based economy (see below). “The ABPI supports these ambitions and we look forward to working with our members to bring new investment to the UK to further strengthen our world-leading science base. The Prime Minister’s Brexit deal includes an important commitment to exploring close cooperation on medicine regulation. Achieving this will be important in prioritising patients and public health as well as the future of the UK life sciences sector”, said ABPI chief executive, Mike Thompson.
“A Conservative majority offers a new era of political stability at Westminster, which makes long term business decision making simpler for our sector”, added Steve Bates, chief executive of the UK Bioindustry Association (BIA). Expectations for the post-Brexit include the creation of the Innovative Medicines Fund, an expanded R&D tax credits, and fulfilling the PM’s “personal pledge of the ‘fastest ever increase’ in R&D spending. Our key priorities are ensuring companies can continue to access the capital and talent they need, working in partnership to deliver the life sciences strategy and ensuring NHS patients continue to access the latest innovative medicines”, said Steve Bates.
ABPI’s comments on the electoral manifestos
Both the Conservative and Labour parties published their electoral programmes including the foreseen actions in the pharmaceutical and healthcare sectors. ABPI commented the two manifesto from its website.
The Innovative Medicines Fund should represent for the Conservatives the tool to support innovative therapies in the field of tumors, rare and autoimmune diseases. The new Fund should be an expansion of the Cancer Drugs Fund, and it should be granted an investment of £ 500 million for the first year; among its duties may figure also the conditional reimbursement of medicines for some types of diseases. According to ABPI, its real impact would depend greatly on the increasing number of innovative therapies reaching the market. The industrial association disagreed with the tools proposed by the Labour’s manifesto, e.g. compulsory licensing and the creation of a “governmental” manufacturer of generics drugs.
The Conservative’s intent to make the UK a global hub for life sciences after the Brexit, with a planned R&D expenditure reaching the challenging goal of 2.4% of GDP, has been also welcomed by ABPI. A new agency to manage high risk and high potential initiatives is another interesting feature that according to the Association might prove critical to facilitate new public-private partnerships. Support to basic R&D and the increase of tax credit up to 13% for R&D activities (and possibly also for investments in cloud computing and data management) are other positive elements of the Conservative programme.
The current Apprenticeship Levy tool to attract talents is considered insufficient; the proposal of ABPI sees the creation of a new Life Sciences Skills Fund to fill the knowledge gaps in genomics, immunology, bioinformatics, chemo-informatics and clinical pharmacology.
A hot issue such as drug prices were missing from the two electoral manifesto, noted Richard Staines on Pharmaphorum just after the general elections. According to the article, US and UK negotiators were preparing to expedite new trade agreements that will maximise the patent protection period for biologic drugs.
This goal would have a double impact from the US point of view, explains Richard Staines, both on the US election in November 2020 and in shaping the future UK’s pharmaceutical market.