Euro Roundup: New EFPIA leaders share wish list of changes to draft pharmaceutical legislation

The newly elected EFPIA presidency team has shared a list of requested changes to EU draft pharmaceutical legislation. EFPIA, a trade group representing large pharma companies, wants the EU to work on “further optimizing the regulatory framework and maximizing use of expedited pathways.”

Industry leaders criticized the draft EU legislation before and after its publication in April. EFPIA Director General Nathalie Moll warned that the proposals “undermine research and development in Europe while failing to address access to medicines for patients” and argued that “penalizing innovation if a medicine is not available in all member states within two years is fundamentally flawed and represents an impossible target for companies.”

Since then, EFPIA has elected a new presidency team to work alongside Moll. Novo Nordisk CEO Lars Fruergaard Jørgensen has taken up the post of president, with Stefan Oelrich, head of pharmaceuticals at Bayer, and David Loew, CEO at Ipsen, serving as first and second vice presidents respectively.

The new team met in Brussels last week to reiterate their concerns about the draft legislation and let EU officials know that EFPIA wants to collaborate on revising the document. While noting that “the proposed legislation does begin to evolve Europe’s regulatory system, which has not been extensively modernized in the last twenty years and is increasingly slower than the US and other leading regions,” EFPIA requested five changes to the draft.

EFPIA’s first request is for the proposals to “deliver on the core purpose of Europe’s pharmaceutical legislation by further optimizing the regulatory framework and ensuring maximum use of expedited pathways in support of patient needs.”

The trade group also wants the EU to “strengthen, rather than cut,” the baseline of regulatory data protection and orphan drug market exclusivity while “creating separate incentives to drive innovation and meet health care challenges.” The reduction of the minimum period of regulatory protection from 10 years to eight years is one of the most contentious changes in the draft, from an industry perspective.

Across the other requests, EFPIA is pushing EU officials to address barriers to access to new drugs “based on a shared understanding of the evidence generated by the recently published Industry European Access Hurdles Portal;” “include a patient-centered, broad definition of unmet medical need” to incentivize research; and ensure “supply chain and environmental requirements are proportionate and fit for purpose.”

Press Release

EMA seeks industry input on quality requirement guideline for mRNA vaccines

The European Medicines Agency (EMA) is collecting feedback on its plans to create a guideline on the quality aspects of mRNA vaccines such as Moderna’s Spikevax and Pfizer’s Comirnaty.

Messenger RNA went rapidly from an emerging modality to a widely used vaccine technology during the COVID pandemic. The pace of R&D outstripped the advance of regulations, leaving EMA without a guideline that reflects the quality requirements for regulators and industry on such vaccines.

EMA now plans to draft a guideline about mRNA vaccines against infectious diseases, including products that contain self-amplifying mRNA, setting out its plans in a draft concept paper. The agency also plans to draft a guideline that follows the structure of module three of the common technical document “where relevant” and that addresses finished product considerations such as the choice of excipients.

The guideline will discuss the control of starting materials, development of integrated control strategies, approaches to characterization, purity control strategies and more. EMA also plans to address regulatory considerations and challenges related to the development and testing of bivalent and multivalent vaccines, self-amplifying mRNA, and the use of delivery systems other than lipid nanoparticles.

EMA is accepting feedback on the draft concept paper until 30 September. Once the consultation ends, EMA’s Biologics Working Party will draft the guideline and release it for a six-month review. The final guideline will come into operation six months after being adopted by EMA.

Concept Paper

Pediatricians push for urgent action to stop MDR from disrupting medical device supply

The European Academy of Paediatrics (EAP) has warned urgent action is needed “to secure continued access to essential medical devices for children and for patients with orphan diseases.”

In a letter to Stella Kyriakides, the European Commissioner for Health and Food Safety, leaders at EAP and other pediatric bodies outlined how the Medical Device Regulation (MDR) is affecting the availability of products that target small patient populations. Because MDR has “hugely” increased time and cost burdens on industry, manufacturers are withdrawing devices sold in smaller numbers.

The letter cites the removal from the market of balloons used in a life-saving maneuver and reports of shortages of dialysis machines used in young children. The pediatricians said the new MDR timelines “will not halt the disappearance of essential medical devices from the EU market.”

To correct the problem, EPA and its coauthors want the EU to create pediatric and orphan device statuses that are eligible for “a simplified, fast and low-cost” conformity assessment. The pediatricians cited the United States’ Humanitarian Device Exemption regulation as an example.

EAP Letter

EMA finalizes guidance on clinical trials of medicines to treat and prevent diabetes

EMA has finalized its guideline on the clinical investigation of medicinal products used in the treatment or prevention of diabetes.

The publicaiton concludes a review process that lasted for almost six years. EMA agreed to a draft late in 2017 and released it for consultation early the following year. However, the agency put implementation of the comments on hold because of its move to Amsterdam and COVID. Returning to the project last year, EMA identified more areas that may benefit from changes and released a draft reflection paper.

Now, having considered the feedback gathered in 2018 and 2022, EMA has finalized the guidance. The text is dominated by two sections, one about the development and licensing of insulin preparations for type 1 and type 2 diabetes, and one about the development and licensing of all other types of medicines for type 2 diabetes.

Changes since the 2018 version include the removal of references to metformin. EMA made the change after seeking feedback in the reflection paper on whether it is “still relevant to reflect the first line status of metformin.”

Final Guideline, Industry Feedback

Medicines for Europe signs pact to accelerate Ukraine’s integration into EU pharma market

Medicines for Europe has signed a memorandum of understanding to accelerate the integration of Ukraine into the EU pharmaceutical market.

The agreement, which the off-patent drug trade group signed with the European Business Association, is intended to support cooperation on the “approximation of Ukraine's regulatory environment to EU standards,” collaboration between national regulators and the integration of the country into European quality and safety systems such as EudraVigilance.

Ukraine has already begun moving toward EU standards, including by passing a law intended to prevent the trade of falsified medicines, and work is set to continue this year. The roadmap includes regulation of 2D codes to verify medicines.

“The implementation of the new drug verification system needs high-quality organizational preparation on the part of both the state and business. Therefore, the joint work continues,” Maria Karchevych, Ukraine’s Deputy Minister of Health for Digital Development, said.

Press Release

Euro Roundup: New EFPIA leaders share wish list of changes to draft pharmaceutical legislation

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