Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
UK Politicians Tell Government to Grant Debates on No-Deal Drug, Device Legislation
Committees of British politicians have pushed back against the government’s attempts to adopt new drug and medical device legislation without holding debates in Parliament.
Last month, the UK government proposed changes to legislation intended to ensure the rules covering drugs and medical devices are fit for purpose in a no-deal Brexit scenario. The original documents were published ahead of the UK’s original anticipated departure date from the EU earlier this year. With an extension pushing the departure back until October, the government proposed changing the legislative documents “to correct drafting defects and omissions.”
The government wanted to make the changes without giving politicians the chance to debate them in Parliament, but that plan has hit resistance. Both committees tasked with assessing whether legislation is suitable for the fast track that bypasses Parliament disagreed with the government’s plan and recommended that politicians have an opportunity to debate the changes.
Under the rules covering statutory instruments, the government minister overseeing a particular piece of legislation can reject the committee recommendations, provided they publish a statement explaining their decision. However, in practice government ministers have accepted all but one of the previous debate recommendations. In the one exception, the minister did not reject the committee recommendation outright. Rather, they amended and resubmitted the legislation.
The government is yet to respond to the recommendation about the drug and device legislation. If the government accepts the recommendation, it will open up the legislation to debates that could lead to changes to the documents.
In their current form, the government proposals feature everything from minor revisions to wording up to the introduction of whole sections that are absent from the legislation adopted earlier this year.
The addition of a section on pediatric investigation plans (PIPs) is among the more substantial changes the government hopes to make to the human medicines legislation. In the new, 900-word section, the government details the rights of applicants to make representations to the licensing authority to discuss decisions about PIPs. That change, and others relating to orphan drugs, are intended to “accommodate the process for seeking advice and making representations in relation to the new decisions conferred on the licensing authority by the Medicines Exit Regulations.”
Elsewhere, the government hopes to make small but consequential changes to the text. For example, one change is intended to create a temporary exemption to the requirement for companies to maintain a pharmacovigilance system master file covering all their products authorized in the UK.
UK Drafts Legislation to Ensure SPC Waivers Function in Event of No-Deal Brexit
The UK Intellectual Property Office (IPO) is seeking feedback on draft no-deal Brexit legislation about supplementary protection certificate (SPC) waivers. IPO wants to introduce the legislation to ensure the manufacturing waiver introduced by the EU applies in the UK after Brexit.
Despite opposition from branded drugmakers, the European Parliament adopted legislation to create an SPC waiver earlier this year. The waivers will permit manufacturers operating in the EU to produce active pharmaceutical ingredients and finished products that are protected by SPCs for export and to stockpile ahead of the expiration of the certificates.
As the Parliament adopted the legislation after the UK was due to leave the EU, IPO did not prepare legislation ahead of the original Brexit departure date. However, with the UK deferring Brexit and remaining committed to transposing EU law, IPO has set out how it will adopt the waiver.
The draft released by IPO details the changes it will need to make to the EU legislation to adapt the text to the UK. For example, references to manufacturing taking place “in the Union” do not fit with the UK’s anticipated post-Brexit status. IPO plans to resolve that issue by amending the text so it is clear manufacturing is permitted in the UK for export or stockpiling for local use.
By releasing the draft for consultation, IPO hopes to learn whether these proposals and other changes will have the desired effects. IPO wants to know whether the industry foresees any problems with its changes to clarify what the waiver permits, and gather views on its plans to replace references to “third countries” with “outside the United Kingdom.”
IPO is accepting feedback on the draft until 9 August.
Swissmedic Responds to Increase in Formal Objections After GCP Change
Changes to Swiss rules on regulatory filings related to clinical trials have led to a surge in the number of incomplete or inadequate submissions, according to the country’s regulator. The Swiss Agency for Therapeutic Products (Swissmedic) is working on an update intended to resolve the problems.
Since the start of 2019, Swissmedic has required all application types whose documentation covers clinical trials, including bioequivalence studies, to complete a European Medicines Agency (EMA) good clinical practice template. That requirement appears to have caused some companies problems.
In a brief notice, Swissmedic stated, “This new requirement has resulted in an increase in formal objections,” the agency’s term for requests to resolve shortcomings in regulatory submissions. Work is underway to help applicants comply with the requirements.
“Swissmedic will soon be including the appropriate information regarding submission of the EMA template on the application submission forms,” the agency wrote.
Swissmedic Offers to Accelerate Processing of Orphan Drug Filings, For a Fee
Swissmedic will open up its procedure with prior notification (PPN) process to orphan drug filings at the start of August. PPN permits companies to request a 20% reduction in how long Swissmedic takes to process applications if they pay twice the usual fee.
Switzerland introduced PPN in 2013 and spent the next few years refining the process. Throughout the refinement process, the concept behind PPN has remained the same. Applicants give Swissmedic advanced notice of their intent to make a regulatory filing and ask the agency to truncate the review in return for a bigger fee.
Filings for orphan drug status were ineligible for PPN when Swissmedic introduced the scheme. That is set to change at the start of next month. While Swissmedic does not charge a flat fee for first-time orphan drug filings, it will demand a supplement from companies that use the PPN program.
The changes have implications for the fast-track authorization procedure. Swissmedic said it will apply the pay-for-performance principle to the procedure. Fast-track applications for orphan status will not be charged a flat fee from 1 August onward but will be subject to a supplement.
Public Health England
(PHE) has published guidance on the application of the Falsified Medicines Directive (FMD) to the drugs and vaccines it supplies. Some products supplied by PHE are unlicensed and as such are exempt from the FMD requirements. PHE also states that it has a large volume of stock that was produced prior to the implementation of FMD. These products lack safety features but are outside the scope of the FMD. PHE Guidance
’s Health Products Regulatory Authority
(HPRA) has said it will include the CESP submission number on all confirmation of validation emails relating to human medicines. HPRA thinks the change will make it easier for applicants to trace and manage filings that have passed validation. HPRA Notice