by Peter O'Donnell
BRUSSELS, July 11 (APM) - The shockwaves of the UK vote to leave the European Union continue to ripple through all aspects of the European healthcare scene, with uncertainty still hanging over the likely impact - and not just for the widely-discussed issue of relocating the European Medicines Agency (EMA).
Among the personalised medicine community, already struggling to find a coherent European voice across the many distinct domains that precision medicine must engage with, "the recent UK referendum vote in favour of 'Brexit' will not help," according to Denis Horgan, secretary general of the European Alliance for Personalised Medicine (EAPM).
"Given that healthcare is a member state competence and health services across Europe are already disjointed, collaboration between UK and EU scientists, as well as those experts operating in the field of, for example, big data may well become harder," he said this week.
European organisations point to innumerable implications of the Brexit vote, including clinical trial regulation.
"There is sure to be an impact in clinical trials, regulation, marketing authorisations, and pharmacovigilance," EAPM pointed out.
It said the new clinical trials regulation, with its aim of greater collaboration and less red tape, in order to benefit of research and patients, "will face extra administration problems for trials in EU countries if a post-Brexit UK steps back from the legislation".
Good manufacturing practice requirements, where the UK currently adheres to EU standards that allow export and import of medicines across the EU, could create difficulties if the UK's performance is no longer accept as equivalent to the EU.
And for marketing authorisation, if the UK drops out of the EMA's procedures, a company would need a separate national authorisation to market a medicine in the country.
The effectiveness of pharmacovigilance, which the EMA currently coordinates EU-wide,ensuring speedy collection of data, reporting of adverse reactions, risk management, and transparency by health services, will also be compromised by UK withdrawal.
EAPM said: "[D]espite the referendum result, the Alliance continue its work within all these sectors (and more) with its affiliates in the UK, and with those across the remaining member states."
European pharmacists are also disconcerted at the prospect, according to the Pharmaceutical Group of the European Union (PGEU).
Jurate Svarcaite, secretary general of the PGEU, told APM that "apart from shock and general disappointment there are practical issues" - including whether UK staff member of the Brussels-based association will need to obtain a work permit in two years time.
In addition, PGEU members elected a British citizen, Rajesh Patel, as president for 2017.
Despite his initial shock and disbelief, Patel confirmed his personal and professional commitment of the UK delegation to the grouping.
PGEU said Patel remains "committed to participate and provide support to PGEU no matter what happens and how things turn out between the UK and the EU".
Martin Fitzgerald, deputy director general at the European Healthcare Distribution Association, told APM that his members anticipate limited direct impact since pharmaceutical full-line wholesaling is a business activity carried out within national borders.
There are potential ramifications, however, commenting: "[W]e will have to consider the broader implications over the course of the weeks, months, even years, during which time we hope indications will emerge on what the future relationship between the UK and the EU will look like and when the full fall-out from these developments becomes clearer."
"Some degree of clarity on the options for the future relationship will be key to for all to fully consider the impact," he added.
Past-president of the European Hematology Association Christine Chomienne said: "With Britain now not too far away from quitting Europe in a legal and practical sense, there are still current and future patients to think about. And their needs must still be met. Training for their doctors and nurses is vital. In fact, it is now more important than ever."
Eurordis, the rare diseases grouping in Europe, says "it is still unclear what the outcome of Brexit will mean for people living in the UK and for the EU as a whole".
But it says it will not be deterred from its mission by changes in the political superstructure.
"What remains certain however is the mission of Eurordis to represent the voice of people living with a rare disease in Europe, not only those living in the European Union but in all 48 countries in Europe," said the organisation.
"We will work closely with Rare Disease UK, Genetic Alliance UK and all Eurordis members in the UK to advocate for UK rare disease patients and their families to continue to benefit from EU regulations and actions, which affect their quality of life and the availability of and access to treatments.
"We must move forward to analyse the impact and to start a dialogue to deal with the fallout so that people living with a rare disease in the UK do not suffer the consequences of Brexit."
On the prospects for the London-based EMA - the latest bid to be the new host city post-Brexit comes from Malta, adding a fifth country to the current list of aspirants - Eurordis chief executive officer Yann Lecam took a pragmatic line.
"There is no reason to rush out of London. What counts is to focus all our attention on the current challenges in adapting the regulatory approach to new science opportunities so as to speed up approval and patient access, to meet unmet medical needs".
His comments chime with those of EFPIA boss Richard Bergström, who recently remarked that the rush to relocate the agency should not be allowed to distract attention from the importance of the agency's work - and from the real personal problems that abrupt action would cause to its hundreds of staff.
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