Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
UK Talks Up Prospect of No-Deal Brexit Accelerating Access to New Medicines
The British health minister has talked up the prospect of a no-deal Brexit accelerating access to new medicines.
After receiving clear feedback from industry about the importance of harmonization, the government largely stopped talking about adopting a divergent, lighter medicine regulatory system upon leaving the European Union. However, with the UK set to leave the EU without a deal in three weeks unless a parliamentary majority coalesces behind an alternative, the government is now again discussing the perceived upside of a hard split for drug developers.
Talking in Parliament, Health Secretary Matt Hancock said the UK will respond to a no-deal exit by matching some European Medicines Agency (EMA) processes to ensure Brexit does not create more regulatory burdens. That is in line with the government’s long-held position but is just one part of Hancock’s thinking.
“In a no-deal scenario we would also be looking to introduce our own processes so that some medicines could be brought and licensed here before they could be licensed in Europe. Indeed, changes to this area is one of the examples of advantages from Brexit,” Hancock said during a debate in Parliament.
Hancock made the comments during a discussion about the government’s decision to settle a case brought against it by Eurotunnel, a transport company. Eurotunnel took legal action after the British government awarded ferry companies contracts to ship medical supplies into the UK in the event of a no-deal Brexit. The government will pay Eurotunnel up to £33 million ($43 million).
Politicians outside the government saw the settlement as a move to minimize losses from a case that would have found it had breached procurement rules. The government framed the settlement in a different light, arguing that it was necessary to ensure the uninterrupted supply of medicines.
EMA Changes Process for Meeting Attendees Following Move to Amsterdam
EMA has created a new process for industry representatives attending scientific advice meetings and other gatherings. The new process is designed around the limitations of EMA’s temporary home at the Spark building in Amsterdam.
The Spark building, like EMA’s former London office, houses an industry lounge. However, the Spark lounge is notably smaller than the one in London, forcing EMA to rethink how it handles the arrival of representatives of pharmaceutical companies for scientific meetings. EMA set the new system out in an industry-focused orientation guide to its temporary home in the Netherlands.
While EMA is at Spark, companies must provide it with two mobile phone numbers for their contact person before arriving in Amsterdam. On the day of their meeting, companies should send one person to reception to inform EMA of their arrival. All other representatives should wait outside Spark but within a 10-minute walk of the building.
EMA will call the company representative 35 minutes before the start time of their oral explanation and ask them to come to reception. The attendees will then receive security passes and either wait in the industry lounge or be taken to a designated room until the oral explanation starts.
The process, which is more convoluted than that used by EMA in London, is a temporary measure necessitated by the fact the Spark building is smaller than the agency would like. Once EMA is in its permanent home, it should have facilities that are a better fit for its needs.
France Clarifies Raw Material Importation Rules in Anticipation of Brexit
France has published recommendations for companies that want to import raw materials from the UK after Brexit. The advice is based on the assumption that the UK will be a classed as a third country upon leaving the EU.
To help importers prepare for such an eventuality, the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) has detailed the requirements for companies that want to bring active substances and excipients into the country. The requirements for active substances are more involved.
In both cases, the importer must register with ANSM. When dealing with active ingredients, the importer must also provide a written confirmation from the UK certifying that the materials were produced to EU-level good manufacturing practices at a facility that is subject to regular, repeated and unannounced inspections.
The requirements are underpinned by European texts transposed into French law, and as such similar rules will apply in other countries. France’s enforcement of the rules is particularly important, though, given its status as the UK’s gateway to many EU member states.
Ireland Sets Out How Companies Can Continue Batch Testing in the UK After Brexit
Ireland’s Health Products Regulatory Authority (HPRA) has set out how companies can apply for temporary clearances to continue batch testing in the UK after Brexit. The guidance follows a recent decision by the European Commission to permit time-limited exemptions to the normal rules.
If the UK leaves the EU without a deal this month, it will be treated as a third country and therefore become ineligible as a location for batch testing of products sold in the remaining member states. As this could cause supply disruption, the Commission is allowing competent authorities to temporarily waive the rule requiring that batch testing takes place in the European Economic Area.
EMA will handle exemption requests for centrally authorized products, with competent authorities in member states overseeing the process for nationally authorized products. In anticipation of receiving requests, HPRA has shared details of the process.
HPRA wants companies to request exemptions “without undue delay” and by 29 March, the day the UK leaves the EU, at the latest. Requests to HPRA should be sent in emails with “Brexit batch control testing exemption” in the subject line to its article50changes@HPRA.ie address..
EMA also addressed requests to delay the transfer of batch control testing and other topics in a recent update to its question and answer document on the effect of Brexit on regulatory procedures.
, EMA Q&A
France Adopts Online Portal to Streamline Access to Unapproved Medicines
France has introduced an online portal to handle requests for access to unapproved medicines. The portal is intended to make it easier for healthcare professionals to get these drugs to the roughly 20,000 patients who rely on them every year.
While most drugs pass through clinical trials and the regulatory approval process, some medicines never follow this pathway despite there being evidence of clinical benefits to patients. France used to operate a fax-based system for healthcare professionals that wanted to request access to these drugs but is planning to phase this out and replace it with an online portal.
The portal has now completed a pilot assessment at certain hospital pharmacies and been made available to all healthcare professionals who have the required card reader. ANSM is giving facilities until September to install the required technology. After that, ANSM will cease accepting faxes for routine requests. Starting next year, ANSM will no longer have the ability to receive faxes.
ANSM thinks the system will realize benefits beyond enabling it to get rid of its fax machines. The agency foresees the portal reducing its response times and making communication with healthcare professionals more secure.