European Regulatory Roundup: Brexit Could Lead to New Regulatory Burdens (25 February 2016)

Regulatory NewsRegulatory News | 25 February 2016 |  By 

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Industry Leaders Warn Brexit Would Lead to Significant Regulatory Burdens

More than 50 leaders of the British biopharmaceutical industry have warned of the regulatory and business upheaval that could result from the United Kingdom leaving the European Union, an event dubbed “Brexit.” In a letter in The Financial Times, the executives argue leaving the EU would result in “significant regulatory burdens” and diminish the status of U.K. medicine institutions within the region.

The 55 executives, who include AstraZeneca CEO Pascal Soriot and GlaxoSmithKline Pharmaceuticals R&D President Patrick Vallance, released the letter days after UK Prime Minister David Cameron set the date for a referendum on EU membership. Polls suggest the public is fairly evenly split between those who want to stay in the EU and those who want to leave, but the biopharmaceutical industry is overwhelmingly against exiting the union. This viewpoint, which has been expressed several times in recent months, is underpinned by worries about the effect of Brexit on drug regulation.

“Over a generation, regulators and legislators have built up an integrated European regulatory framework for clinical research and development of new, innovative medicines. It is cornerstoned in the UK, and has significant UK input,” the executives wrote. “If the UK were to leave the EU it would risk unpicking all of that successful work. It would affect regulatory frameworks, the leadership role of the UK’s Medicines Healthcare Products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) in the EU ... and most importantly patient access to medicines.”

If the UK cuts itself off from the Europe-wide regulatory machinery, the authors of the letter foresee “disruption, expense and significant regulatory burdens for a new authorization system.” As with all aspects of the UK’s relationship to the EU, details of how its regulatory system will interact with the rest of Europe in the event it leaves the union are yet to be established. Norway, which is outside the EU but in the European Economic Area, is covered by the centralized authorization procedure. Switzerland, another non-EU country, has mutual recognition and sharing agreements with Europe.

A variation on these types of relationships could await the UK if it leaves the EU, although its situation is complicated by the fact that it is has spent decades forging ever-tighter bonds to its neighbors. If the UK now severs these bonds, the European Medicines Agency (EMA) is expected to relocate from its current base in London. Similarly, plans to use London as the location of the court at the heart of the incoming EU-wide patent system would likely change, as would the UK’s involvement in the initiative itself. 

Euroskeptics claim the UK will be better off once it no longer has to comply with such EU regulatory programs, but the argument has found little favor in life sciences. George Freeman, the UK minister for life sciences and a vocal critic of aspects of the EU, has joined the industry he represents in calling for the UK to vote to stay in the union.

FT Letter, Bloomberg, Freeman Statement

Proposal to Curb Antibiotic use Heads to Vote After Clearing Public Health Committee

The European Parliament Committee on the Environment, Public Health and Food Safety (ENVI) has voted in favor of measures to restrict the use of antibiotics in farm animals. Having won the support of the committee, the proposal is now set to be debated by the European Parliament and put to a vote within the next two months

Under the terms of the proposal, farmers would be banned from the mass prophylactic use of antibiotics. In the absence of clinical signs of infection, farmers would only be able to give antibiotics when such an action was justified by a veterinarian. Even then, the farmer would be limited to giving the antibiotics to single animals. Similarly, metaphylaxis, the practice of mass medicating a group of animals when one appears infected, would be restricted. Only clinically ill animals or individuals at high risk of contamination could be treated with antibiotics.

ENVI sees the measures stopping routine, large-scale use of antibiotics to improve the performance of a farming operation. Moving away from an antibiotic-driven method of herd health management will require a shift in outlook for some farmers. “[Members of the European Parliament] urge farm animal owners and keepers to use stocks with suitable genetic diversity, in densities that do not increase the risk of disease transmission, and to isolate sick animals from the rest of the group,” ENVI wrote following the vote.

The package of measures, which includes a proposal to draw up a list of antimicrobials reserved for use in humans, is now passing to the European Parliament. Members of the European Parliament are scheduled to debate and vote on the measures at a plenary session in either March or April. The plenary session will also cover a proposal relating to the decoupling of the centralized marketing authorization for veterinary and human medicines. ENVI overwhelmingly voted in favor of the proposal.

ENVI Statement

EMA Drafts Eligibility Criteria for Industry Involvement in Regulatory Activities

EMA is preparing to share eligibility criteria for the involvement of industry associations in regulatory activities. The regulator, which started discussing the criteria late last year, revealed it is nearly ready to share its draft terms for consultation during its first annual bilateral meeting with the European Generic Association (EGA).

After sharing the criteria, EMA will gather feedback with a view to finalizing terms it sees ensuring it transparently works with the most suitable representatives of the groups its regulations affect. The rethinking of how EMA selects the associations with which it interacts is part of a broader revision of the framework covering these relationships. EMA detailed the new framework, which includes plans to create a public register of eligible associations, in October.

As part of the process, EMA is finalizing an “overarching stakeholder’s management framework” and its first annual industry partner report. EMA discussed both initiatives when it met with EGA late last month. The regulator also used the meeting to outline plans to run an initial marketing authorization application survey this year.

EMA Report 

CVMP Readies Draft Regulatory Documents on Efficacy Studies, Bioaccumulation

EMA’s Committee for Medicinal Products for Veterinary Use (CVMP) has agreed on the wording of a clutch of draft regulatory documents. The texts, which are yet to be published, cover CVMP’s views on efficacy testing of intramammary products for use in cattle, drugs containing bioaccumulative or toxic substances and other topics.

Having agreed on the texts at a meeting last week, CVMP is set to publish them soon. The cattle intramammary efficacy text is a revision of an earlier draft guideline, to which CVMP has added an annex on biowaivers. CVMP, which made the change following a public consultation, is set to gather feedback on the latest version of the guidelines over the next few months.

The feedback period will run in parallel to consultations about other draft texts being developed by CVMP. As well as the aforementioned reflection paper on products containing bioaccumulative or toxic substances, CVMP is preparing to release texts about sterilization and chemical structures. The sterilization and chemical structure texts are, respectively, a draft guideline and reflection paper.

CVMP Release


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