EU Pharma Bosses warn of Brexit medicines threat
Financial Times, Sarah Neville, 13 July 2017

The Financial Times has reported that EU pharma bosses have warned against a “disorderly Brexit”, following on from the joint ABPI-EU letter to Michel Barnier and David Davis. The FT calls it the ‘first coordinated response’ from the pharmaceutical industry about the potential impact on Brexit. All the associations warned against ‘severe disruptions’. The CEO of the ABPI, Mike Thompson, said that the desired goal would be ‘frictionless trade’ between the EU and the UK facilitated, once the 2 year negotiating period is complete, by a common standard of regulations.

EU & UK pharma leaders write to Brexit negotiators
PharmaTimes, Selina McKee, 13 July 2017

PharmaTimes called the letter to Michel Barnier and David Davis an ‘unprecedented move’. PharmaTimes commented that it is clear that “close cooperation should be the ongoing priority” in negotiations. The letter noted that the current system is maintained“through a sophisticated system of legal and regulatory arrangements” that would require cooperation to be maintained. The letter further stated that the Medical and Healthcare products Regulatory Agency (MHRA) played a vital role and that any loss of cooperation would lead to a ‘loss of capacity’ in the UK and the EU.

Brexit Health Alliance welcomes collaborative EU relationship
European Pharmaceutical Review, Niamh Marriott, 13 July 2017

Responding to the previous commitment from Health Secretary Jeremy Hunt and Business Secretary Greg Clark, to cooperate with the EU on matters of medical and pharmaceutical regulation, the Co-Chair of the Brexit Health Alliance Niall Dickson said it was a ‘very welcome signal’. He called the determination to cooperate necessary, saying “we must maintain the highest possible level of collaboration and regulatory alignment.” The Brexit Health Alliance brings together stakeholders from the NHS, research, public health organizations and patient associations to advocate for changes in light of Brexit.

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Davis proposes transition period for EU agencies in UK after Brexit
Politico Europe,  Helen Collis, 13 July 2017

LONDON — The U.K. wants to grant EU organizations and agencies “privileges and immunities” to continue operating in the U.K. for a certain period of time after Brexit — opening the door to a transition period for the European Medicines Agency and the European Banking Authority to relocate from London.

“These privileges and immunities should reflect the extent of the U.K.’s continued involvement in any EU programs, agencies or other activities,” stated one of several briefing papers issued Thursday by the Department for Exiting the European Union.

The U.K. would grant these for international organizations “primarily on the grounds of functional need.”

This is as per international law, the government argued, and also recognized in Protocol 7 of the Treaty of the Functioning of the European Union.

Europe’s life sciences sector has raised serious concerns over the timeframe for Brexit. In a letter to chief Brexit negotiators David Davis and Michel Barnier on Wednesday, eight trade groups urged them to consider continued cooperation of medicines regulations as soon as possible, given public health concerns and the extent of the extra workload for the industry and the regulators.

A transition period would ease these pressures.

The government said these privileges and immunities would “apply for a limited period after exit, in order to permit the EU a reasonable time in which to wind up its current operations in the U.K.”

“The scope and duration of such a transitional period may be different for different types of asset or agency,” the briefing paper says.

Davis’ department aims to start these talks as soon as possible.

EU & UK pharma leaders write to Brexit negotiators
PharmaTimes, Selina McKee, 13 July 2017

In an unprecedented move, eight leaders from associations representing the entire EU and UK pharmaceutical sector have written a joint letter to chief Brexit negotiators Michel Barnier and David Davis requesting that ongoing cooperation between the two territories for medicines be a negotiating priority.

Securing an agreement between the EU and UK “is the best way of ensuring that patients across Europe and the UK are able to continue to access safe and effective medicines and to ensure that there is no adverse impact on public health,” the letter states.

The industry is highly integrated across Europe and regulated under EU law “through a sophisticated system of legal and regulatory arrangements between EU institutions, Member States and national competent authorities,” it notes, adding: “It is important that there is as much certainty as possible, as early as possible, to enable the pharmaceutical and life science industry to transition smoothly into the new framework, ensuring there is no disruption to patient access to medicines”.

The leaders call for the maintenance of previously granted European marketing authorisations both in the UK and the EU and continued cooperation between national authorities as facilitated by the European Medicines Agency and European Commission, and also stress that any changes to the EU-UK trading relationship “should not adversely affect the research, development, manufacture and supply of medicines across Europe, including for clinical trials.”

They also note that the UK’s MHRA currently makes “a significant contribution” to the work of the European regulatory network, and argue that there its withdrawal “would mean a loss of capacity and expertise for the network for the review of medicines as well as the capacity across Europe for the surveillance and safety supervision of products.”

The letter warns that, in the case of an “unorderly withdrawal”, there is a risk that all goods due to be moved between the UK and EU could be held either at border checks or in warehouses subject to extensive retesting requirements. “This would lead to a severe disruption of most companies’ supply chains, which would lead to potential supply disruptions of life-saving medicines.”

​An implementation period should also be agreed on by negotiators to allow pharmaceutical and biotech companies to transition to a new framework and “avoid any unintended consequences on the availability of the medicines.”

The move follows a letter published in the Financial Times last week​ by Jeremy Hunt, Secretary of State for Health, and Greg Clark, Secretary of State for Business, which said the UK “would like to find a way to continue to collaborate with the EU, in the interests of public health and safety” post Brexit.

Brexit Health Alliance welcomes collaborative EU relationship
European Pharmaceutical Review, Niamh Marriott, 13 July 2017

Niall Dickson responds to the commitment by the secretaries of state to seek a collaborative relationship with the EU in medicines regulation and supply…

Responding to the commitment by secretaries of state Jeremy Hunt and Greg Clark to seek a collaborative relationship with the EU in trade, medicines regulation and supply, Niall Dickson, co chair of the Brexit Health Alliance, said:

“This is a really important and welcome signal. If we get these negotiations wrong, there is a real danger that patients could be denied access to cutting edge treatments, and indeed access to a wide range of innovative health technologies. The determination of the UK government to continue with a regulatory system that protects and supports the life science sector is very welcome.

“The current EU medicines research, development and regulatory arrangements work well and benefit from the input of UK academics, regulators and industry. For patients in the UK and across Europe we must maintain the highest possible level of collaboration and regulatory alignment.”

About the alliance

The Brexit Health Alliance brings together the NHS, medical research, industry, patients and public health organisations to safeguard the interests of patients and the healthcare and research they rely on.

The Brexit Health Alliance will complement the work of the Cavendish Coalition, which is concerned with the staffing and workforce implications in health and social care of the UK leaving the EU. The Cavendish Coalition is led by NHS Employers, which is part of the NHS Confederation.

Founding members of the Brexit Health Alliance are NHS Confederation – Co-chair of alliance, Welsh NHS Confederation, Northern Ireland Confederation (NICON), Association of UK University Hospitals (AUKUH), Academy of Medical Royal Colleges (AOMRC), NHS Providers, National Voices, Association of the British Pharmaceutical Industry (ABPI), Association of British Healthcare Industries (ABHI), The Richmond Group of Charities, BioIndustry Association (BIA), Faculty of Public Health (FPH), Association of Medical Research Charities (AMRC), and Scottish NHS Chief Executive Group.


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