BIA Head Attacks Rapporteur Reallocation, But Welcomes Further Clarity On Transition Period
Executive Summary
Steve Bates, CEO of the BIA, is concerned that the EU authorities are overloading national regulatory agencies by reallocating UK rapporteurships to other member states before they are ready to take them on. However, he has welcomed clarification from the UK government over the movement of medicines during any Brexit transitional period.
The CEO of the UK's BioIndustry Association says the EU authorities are jumping the gun by reallocating all UK centralized rapporteurships to other EU member states before it is clear whether there will be some form of continued regulatory relationship between the UK agency, the MHRA, and the European Medicines Agency after Brexit.
During the BIA’s latest Brexit webinar on April 20, Steve Bates noted that the new rapporteurs would be taking over responsibility for authorized drugs that have the UK as rapporteur as of March next year, and this meant that “basically it is full steam ahead for hard Brexit” in terms of the loss of MHRA participation in many elements of EU regulatory work as of March 2019. (Also see "EMA Redistributes Responsibility For 370 Drugs Currently Overseen By UK " - Pink Sheet, 16 Apr, 2018.)
He said the BIA had had some feedback from members who engaged with regulators at the DIA Europe 2018 meeting in Basel last week. It seemed that “where there are areas of interpretation, the EMA, at the behest of the European Commission, are being pretty clear that they expect… the UK to be treated fully as a third country from next March, even where that may not be a great outcome for companies that have already got processes under way that will be difficult to finish by that deadline.”
Bates said this was one reason why he issued a statement last week saying that “removing key expertise and reallocating work to other agencies who are not yet able to take on the work, and expecting them to increase their capability overnight, is an increasingly reckless course of action proposed by the Commission.” He said it was in the interests of patients on both sides of the Channel that the EU “retains access to UK expertise in a post Brexit medicines regulatory framework and that regulatory alignment is maintained to ensure continuity of medicines supply.”
Asked about this during the webinar, Bates said that while there were “significant areas of change” where the EMA had to manage the physical move of the agency and the transfer of staff, there was still the “desire and commitment for a continued part to be played by the UK, which has been a central part of the regulatory community going forward.” Reallocating the dossiers was "immensely disruptive and very difficult to achieve both for the EMA and for other EU agencies, and it requires goodwill and forbearance from all,” Bates said.
He added that there should be some flexibility as to how matters could be handled in a “pragmatic” way, for the benefit of patients. “We have offered ideas, but they don’t seem to have been responded to.”
At the moment, he said, it seems that the Irish border, the customs union and trade are taking precedence in the Brexit negotiations, and “certainly they are choosing not to look at this on a sector-by-sector basis.” The trade associations have “effectively articulated our positions” to the UK, the commission and the EU27 governments,” Bates declared. “I hope these positions are being picked up in the negotiations, but we are not seeing visibility on that yet.”
Transition Period And Movement of Medicines
Of course, the future regulatory arrangements will be determined to some extent by whether or not a Brexit transition period is finally concluded. The UK and the EU reached political agreement on this in March, which has given companies a degree of certainty, but as Bates pointed out, “nothing is agreed until everything is agreed.”
However, he noted that the BIA had received confirmation from the UK government that if a transition period was implemented after Brexit, all goods, including medicines, could continue circulating between the UK and the EU during that period, and that current mechanisms such as batch release would remain as they are under the present regulatory framework.
The concept of “goods on the market” and “placing on the market” are important for companies with regard to the circulation of medicines in the supply chain. Following queries from member companies about the implications in this area of the transition period as put forward in the draft withdrawal agreement, the BIA had asked the government for clarification, Bates said.
In a letter to the association, the parliamentary undersecretary of state for exiting the EU, Steve Baker, said that in order to give certainty to businesses and citizens, “common rules will remain in place until the end of the implementation period. This means that businesses will be able to trade on the same terms as now up until the end of 2020” (the government prefers to use the term “implementation” rather than “transition”).
“During the transitional period, the current regulatory frameworks will remain in place and market access will continue on current terms” – parliamentary undersecretary of state Steve Baker
During the transition period, the current regulatory frameworks – including the EU medicines framework – “will remain in place and market access will continue on current terms,” Baker stated. “This will mean that all goods, including medicinal products, can continue to be manufactured, released and supplied in line with the existing regulatory framework throughout the implementation period.”
A similar view was taken by Grant Castle of law firm Covington & Burling, who said that during a transition period there would be no need, for example, for UK companies that wanted to market products in the EU after Brexit to set up a qualified person for batch release in an EU country.
Article 37 of the draft withdrawal agreement says that any product lawfully placed on the EU or UK market before the end of the transition period – i.e., one that would be QP released in either the EEA or the UK – “may be made further available on the UK or Union market, so there won’t be a need for additional import and QP release as it crosses the EU-UK border,” Castle told an earlier Brexit webinar in March.
“This is without prejudice to customs procedures and tariffs and taxes and things – but from a purely drug regulatory perspective it is correct,” he noted. Until the end of the transitional period there would be no need to import and re-release products across the border, he declared.
“Obviously, subject to what is negotiated for the post-transition phase, there is a possibility and perhaps a likelihood” that products imported to the EU from the UK would need to be QP released after the end of the transition period, Castle said. “There is a possibility that they might have a mutual recognition agreement whereby batch release would be recognized, but we don’t know that yet.”
Clinical Trial Alignment
Bates also noted that during the debate on the withdrawal bill in the House of Lords last week, an amendment had been tabled by Lord Patel calling on the government to align the UK with the EU Clinical Trials Regulation when the legislation's provisions come into force. The amendment was withdrawn after the government gave its reassurance that it would "seek to bring into UK law all relevant parts of the regulation that were within the UK's control," Bates said. The government recognized that there were two key elements that were outside its control and so were not covered by this guarantee: the use of the shared central trials portal, and participation in the single assessment model, which would require "a negotiated UK-EU agreement," Bates said.
From the editors of Scrip Regulatory Affairs.