Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
UK and EU Agree to ‘Explore the Possibility’ of MHRA-EMA Cooperation After Brexit
The EU has agreed to consider continuing to cooperate with the United Kingdom on drug and device regulations after Brexit. UK officials secured the commitment from the EU as part of a text sketching out the future relationship between the two regions.
Under pressure from companies that want a minimally disruptive Brexit, the British government has repeatedly expressed its desire to remain as closely tied to the European Medicines Agency (EMA) as possible. That desire has looked set to clash with the position of the EU, which lacks an associate member status for EMA and has previously stated that its need to retain decision-making autonomy means the UK cannot participate in its agencies as a third country.
Those barriers to UK participation in EMA remain in place. However, the EU has agreed to “explore the possibility of cooperation of United Kingdom authorities with Union agencies.” The EU and UK committed to the exploration in a political declaration that sets out a framework for the post-Brexit relationship between the regions.
The political declaration is designed to complement the previously disclosed withdrawal agreement. Whereas the withdrawal agreement sets out the terms of the UK’s divorce from the EU, the political declaration provides a framework for planned negotiations over how the regions will trade and work together after the separation. As such, the political declaration provides a glimpse of how medicines regulation in the UK may work after the end of the anticipated Brexit transition period.
In the days after the publication of the political declaration, the European Council endorsed the text. The document received a frostier reception in the UK, though, where politicians lined up to criticize the lack of certainty provided by the declaration.
“After more than two years of negotiations, there is no clarity over our status with a range of European-wide agencies: the Erasmus scheme, the Galileo project, Euratom, the European Medicines Agency, the European Chemicals Agency and the European Aviation Safety Agency. On none of these do we know our final status,” Jeremy Corbyn, the leader of the opposition Labour Party, said in a debate in Parliament.
In response to another critic who called the agreement “pathetically weak,” Prime Minister Theresa May defended the declaration by outlining the situation that shaped the text. With EMA lacking an associate member option and Brexit forcing the UK to leave the agency, May found herself seeking a bespoke relationship but unable to put the required legal text in place until after the split from the EU.
May’s argument failed to quell dissent, and there remain significant doubts about whether her Brexit withdrawal agreement and political declaration have the support of Parliament. The situation may become clearer 11 December, when the House of Commons is due to wrap up a five-day debate with a vote on May’s deal.
, Debate Transcript
, ABPI Statement
UK Set to Streamline NICE Appraisals to get Drugs to Patients 6 Months Earlier
The UK has reached an agreement with industry on the future of drug pricing and access. The deal is set to cap the annual increase in spending on branding medicines at 2% but give companies a shot at getting new drugs to market sooner.
Government officials are negotiating the deal with trade group the Association of the British Pharmaceutical Industry (ABPI) to establish a replacement for the long-running Pharmaceutical Price Regulation Scheme. The negotiators are still ironing out some of the details, but have found enough common ground on the big points to publish an outline of how pricing will change in 2019.
The deal seeks to allay government concerns about rising healthcare costs while tackling barriers to new drug uptake that frustrate the industry. That compromise looks set to result in a 2% cap on the annual growth of National Health Service (NHS) spending on branded medicines. If spending goes above the cap, pharmaceutical companies will repay the NHS.
In return, the government is promising to help the industry get drugs through the reimbursement process and to patients faster. Specifically, the National Institute for Health and Care Excellence (NICE) will process more drugs under the shorter timelines currently reserved for cancer medicines. NICE-cleared drugs will also come with guaranteed funding to accelerate uptake by the NHS.
ABPI thinks the changes agreed to by the government could shave up to six months off the time it takes to get new drugs to patients. Other concessions made by the government include continued support for recently approved innovative medicines and attempts to cut the bureaucratic burden on companies.
, ABPI Statement
, Government Statement
ENVI Vote on SPC Waiver Amendments Highlights Rift Between Branded and Generic Sectors
The European Parliament’s health committee has voted in favor of amendments that move a planned supplementary protection certificate (SPC) manufacturing waiver a step closer to reality. The vote triggered contrasting reactions from trade groups representing branded and generic manufacturers.
SPCs extend the patent protection of branded medicines. In doing so, the certificates prohibit the production of SPC-protected drugs in Europe, even if the product is destined for export. The waiver would allow European facilities to make drugs covered by SPCs for export, and to build up stockpiles in anticipation of a certificate being lifted in the EU.
The European Commission proposed the waiver in May and received amendments from ENVI, the Committee on the Environment, Public Health and Food Safety, this week. The amendments neither quell the concerns of branded drugmakers, nor completely satisfy the generic industry.
Big pharma group EFPIA expressed concern about the amendments, arguing that the waiver “sends a signal to the world that Europe is weakening its commitment to IP incentives and innovation.”
The off-patent trade group Medicines for Europe broadly welcomed the progress of the waiver, although it bemoaned that ENVI had “maintained the very long lead time for implementing the waiver which will delay its ability to create manufacturing and access opportunities for many years.”
Advocates of the SPC manufacturing waiver argue it will lower healthcare costs in Europe, grow the generic industry and create jobs by freeing companies from restrictions imposed by the certificates. Critics argue it will make the EU a less attractive location for life science investment.
, EFPIA Statement
, MFE Statement
EMA Shares Draft Recommendations on Developing Drugs for Chronic Liver Diseases
EMA has released a draft reflection paper setting out its recommendations for developers of drugs to treat chronic, non-infectious liver diseases. The paper is intended to help companies develop drugs to treat significant unmet medical needs such as nonalcoholic steatohepatitis (NASH).
Major drug developers including Gilead Sciences and Novartis are targeting NASH and the other liver diseases covered by the reflection paper, namely primary biliary cholangitis and primary sclerosing cholangitis. The therapeutic and financial impact of these medicines could be significant, but only if the companies successfully navigate the challenges posed by the specifics of the diseases.
EMA drafted the reflection paper to help companies overcome the challenges. With that in mind, the text provides general recommendations and sketches out development strategies for each of the liver diseases. EMA plans to firm up the strategies once companies have brought drugs targeting the disease to market.
The agency is accepting feedback on the draft until the end of August.