Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
MHRA Chairman Signs Letter Warning of ‘Complexity and Uncertainty’ of Brexit
The chairman of the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) has signed a letter warning of the “complexity and uncertainty” that could follow Britain’s exit from the European Union (EU). MHRA Chairman Sir Michael Rawlins joined with more than 90 other members of the British biopharma industry to issue the statement.
In the Association of the British Pharmaceutical Industry (ABPI) letter, Rawlins and his cosignatories, who include the CEOs of AstraZeneca and GlaxoSmithKline, outline the perceived benefits of being a member of the EU to their industry and the possible consequences of leaving. As has been the case throughout the pharmaceutical industry’s discussion of the topic in the run up to the 23 June Brexit vote, the regulatory implications of exiting the European Union are at the forefront of the concerns cited in the letter.
“[Remaining part of the EU] would enable the sector to continue to operate within an established and harmonized regulatory approval system, ensuring that UK patients benefit from medicines more quickly, and that medicines researched and manufactured in the UK are available across the EU sooner,” the 93 representatives of the pharmaceutical industry wrote in the letter to The Observer. The signatories present the vote as a choice between the “stability and predictability” of staying in the EU and the “complexity and uncertainty” of Brexit.
The uncertainty stems from the fact that nobody can say for certain how Britain's regulatory system and relationship to its peers in the rest of the EU would function in the event of Brexit. Norway, Iceland and Liechtenstein are all outside the EU but part of the European Medicines Agency (EMA). Britain could assume a similar status in the wake of Brexit, although it is questionable whether advocates of leaving the EU would support the continued direct regulation of British industry by a foreign institution.
The Swiss Agency for Therapeutic Products (Swissmedic), which authorizes products independently but works closely with EMA under mutual recognition and sharing agreements, is another possible model.
Many have doubts about whether any form of partial split would benefit Britain’s life science sector. “Any exit from the European regulatory process would risk leaving the UK on the sidelines unable to influence legislation but still directly or indirectly bound to conform to it,” the Wellcome Trust Sanger Institute wrote in feedback to politicians.
If Britain splits from the EU, MHRA would need to rebuild regulatory capacity capable of reviewing every medicine application independently. At the same time, it is predicted that EMA would relocate its headquarters to outside Britain. Denmark and Sweden have already put their names forward as new sites for EMA. Where this would leave the government’s life science strategy, which is trying to position Britain as a gateway to the European market, is another major, outstanding question.
ABPI Letter, Press Release, The Financial Times, Sanger Comments
EMA Shares Concept Paper on Environmental Risk Assessments of Medicines
EMA has published a draft concept paper on environmental risk assessments of human medicinal products. The release of the concept paper is a precursor to the revision of 10-year-old guidance on the topic, which EMA thinks can be improved by simplifying the implementation of certain aspects of the advice and updating other sections in light of experience gained since its publication.
Officials at EMA have long recognized that the 2006 guideline is imperfect. EMA released a question and answer document in 2011 to address some of the shortcomings, specifically those relating to the perceived complexity of implementing aspects of the existing guideline. However, the nature of the Q&A format meant EMA was limited to clarifying its meanings and intentions. As such, the regulator is yet to fully address some issues that it and the businesses it oversees have encountered repeatedly over the history of the environmental risk assessment (ERA) guideline.
“For some types of applications or products the guideline indicates that the ERA may consist only of a justification where the applicant should explain the reasons why a risk to the environment is not expected. However the assessment of such justifications is often an area of debate due to the lack of guidance for applicants on what constitutes an adequate justification,” EMA wrote in its concept paper. “This is a recurrent issue in particular for known active substances and/or generics, where data protection rules do not allow cross reference without consent from the originators.”
EMA sees value in establishing systems to share data or make periodic updates to the ERA, but its ability to implement such measures is limited by existing legislation. As such, EMA is planning to do what it can to improve the situation within the constraints of the legislative framework. Specifically, officials want to review the possibility of using data that are in the public domain to avoid the unnecessary repetition of animal tests. At the same time, EMA will review which groups of products are exempt from submitting ERA data.
The regulator has given the industry until the end of October to comment on these and other suggestions. Once a final concept paper is in place, EMA anticipates it will take 18 months to draft a revised guidance document.
SMEs Call for Improved Regulatory Assistance in Feedback to EMA
Small and medium-sized enterprises (SME) have asked EMA to offer more regulatory assistance. EMA identified a desire for increased support in a survey of SMEs, in which more than 40% of respondents cited the burden of regulations as a top concern.
Specific issues raised by SMEs polled include the complexity of regulations, the administrative burden of preparing multiple dossiers and the fees associated with certain procedures. SMEs are keen for EMA to address these concerns, for example by providing them with specific contact points at both the European and national level during regulatory procedures while also offering earlier, more informal advice. This broad point was raised by 17% of the 373 respondents.
Other suggestions include a reduction in the cost of European and national regulatory procedures, particularly those relating to pharmacovigilance. Almost 10% of respondents put forward this idea. The same number of people requested a reduction in the regulatory burden. Again, pharmacovigilance is seen as a particular concern. SMEs want a reduction in the number of guidance documents and the frequency with which they are revised.
EMA gathered the feedback as part of a survey to assess the success of the first 10 years of its SME initiative. The responses will feed into the planned drafting of an action plan detailing how EMA plans to help SMEs address the challenges they face in the years ahead.
SME Survey, EMA Report, Press Release
EMA has put out a tender for personalized promotional materials. The regulator is seeking a firm that can supply it with an array of EMA-branded products, including pens, bags, golf umbrellas and other items. EMA has capped the budget for the four-year contract at €60,000 ($68,000). The tender is open until May 24. EMA Notice
MHRA has issued an alert about the recall of a batch of Rifadin by Sanofi. The recall of a single batch was triggered by the discovery that, “It was contaminated with chilled water circulating in the jacket of the reactor during manufacture.” MHRA Alert