Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Scottish Government Dismisses Talk of Compulsory Licensing of Roche Cancer Drug
The Scottish government has dismissed the possibility of using compulsory licensing to get a copy of Roche’s breast cancer drug Perjeta to patients. A politician floated the idea of enacting a Crown use licence to bypass the pricing impasse that is stopping HER2-positive secondary breast cancer patients from accessing the biologic but has struggled to garner support at the top.
Roche tried to secure reimbursement for the drug last year but the Scottish Medicines Consortium (SMC) ruled it was “very expensive” and a poor use of limited healthcare resources. Since then, the Swiss pharma has met with Scottish officials with a view to coming to an agreement but is yet to file a new submission. With breast cancer campaigners pushing to get Perjeta to patients, talk in some quarters has turned to using compulsory licensing to enable production of biosimilar copies.
The idea looks unlikely to advance, though. Talking to the Scottish parliament, Shona Robison, a politician in the ruling Scottish National Party, said the government has compulsory licensing powers but exercising them would not achieve the goal of getting affordable versions of Perjeta to patients.
“We do not consider that invoking that power would provide a quick solution to providing the medicine for patients in Scotland,” Robison said. “An alternative manufacturer would have to go through a lengthy process of obtaining regulatory approval from either the European Medicines Agency or the Medicines and Healthcare products Regulatory Agency before it could make a submission to the Scottish Medicines Consortium.”
Rather than pursue the compulsory licensing approach, Robison and her party are hoping Roche and SMC can reach an agreement that expands access to Perjeta. However, with government ministers having minimal involvement in the process, Robison was unable to provide her peers with a timeline for the resolution of the situation.
Faced with such uncertainty, some politicians want the government to act, partly in a belief that even the threat of compulsory licensing could pressure Roche to lower its price. Advocates of that idea pointed to the effect of Italian compulsory license proposals on drug prices to support their case but the government expressed little interest in going down that path.
EMA Simplifies Veterinary Safety Update Reports Following Industry Feedback
The European Medicines Agency (EMA) has simplified its veterinary periodic safety update reports (PSURs) following discussions with industry. EMA made the changes after a trade group claimed its initial attempted simplifications would actually burden marketing authorization holders (MAHs).
IFAH-Europe, an animal health trade group, raised concerns with the proposed PSURs in feedback to an EMA consultation. The group’s concerns centered on the addition of “differences into production of reports between products,” notably centrally and non-centrally authorized products. This was seen as adding to the burden of MAHs, resulting in that aspect of the proposed revisions failing to simplify the process as intended.
The agency defended the process it used to design the revised PSUR, noting that its structure grew out of talks with stakeholders. The revised PSUR waived the need to provide an electronic line listing if the report was submitted via a single point of entry.
EMA sees these and other changes as positives but has accepted further reductions are needed. The final changes are based on the consultation comments and feedback from MAHs and regulators that are taking part in a pilot project. The result is a PSUR designed to focus on “a critical evaluation of the benefit-risk balance of the product,” giving it a simpler structure.
The simplicity of the process is critical to its success. EMA is encouraging companies to submit details of all suspected adverse events, regardless of their severity, to EudraVigilance Veterinary. Agency officials think this will result in more timely access to safety data, enabling them to act sooner. However, EMA lacks the power to enforce this way of working. As IFAH-Europe wants EMA to emphasize, implementation of the recommendations by MAHs is voluntary.
EMA’s recommendations came into effect at the start of the month.
, Revised Recommendation
, Industry Feedback
Ireland’s HPRA Updates Guide to Interchangeable Medicines
The Health Products Regulatory Authority (HPRA) of Ireland has updated its guide to interchangeable medicines. HPRA made the changes after the Department of Health clarified that the demonstration of bioequivalence is not required under Irish law.
In a section about generic drugs, the previous version of the guide stated “clinical data are usually limited to a study demonstrating bioequivalence with the reference product.” HPRA has revised the wording, stating that clinical data “may include” bioequivalence results, and added a line to clarify that it is possible to bring generics to market without comparing them to reference drugs in “certain circumstances.”
The agency has also changed its definition of an interchangeable medicine. The previous definition said a medicine could only be classed as interchangeable if “bioequivalence has been conclusively established.” HPRA has removed that statement from its definition in the latest version of the guide. The changes bring the guide in line with HPRA’s current understanding of the Health (Pricing and Supply of Medical Goods) Act 2013.
HPRA also used the update to address other issues. Following a request from the Irish Health Services Executive (HSE), HPRA revised its advice on non-prescription and over-the-counter (OTC) drugs. The latest version states such products will be included on interchangeable lists if they are reimbursed by HSE. Previously, all non-prescription and OTC medicines were excluded from the lists.
, Revised Guide
EMA Seeks Legal Advice on Dutch Employment and Labor Laws
EMA is planning to put out a tender for advice on employment and labor laws as it prepares to relocate to the Netherlands. The process will give EMA access to four years of legal advice to help it adapt to the employment rules of its new home.
EMA has given legal experts interested in forming a four-year, €135,000 ($159,000) relationship until 15 June to express their interest in the work. The agency is restricting the contract to organizations that can communicate seamlessly in English and had a turnover of more than €65,000 in each of the last two financial years.
Applicants will also need at least three years of experience of handling issues related to Dutch labor laws and be able to assign two lawyers with a combined five years of relevant experience to the EMA contract.
Securing access to the legal advice will help EMA to acclimatize to the unfamiliar employment and labor laws it will encounter when it relocates to Amsterdam next year.