Euro Roundup: EFPIA warns pharma legislation could slash global R&D over next 15 years

The European Commission’s draft Pharmaceutical Legislation could cost Europe about one-third of its share of global research and development (R&D) by 2040, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA). The trade group forecasts that Germany, Belgium and France will be among those hit hardest by the new framework.

EFPIA has worked to quantify its concerns over the impact of the proposals in recent months, first partnering with Dolon, a strategic pricing and market access consultancy, to create a report on how the draft legislation will affect the availability of rare disease drugs, and now collaborating with the same firm to assess the consequences for R&D in Europe.

Dolon calculated that the European Commission’s proposals to reduce regulatory data protection will cut the incentive for companies to invest in medicines by 55% in Europe over the next 15 years. That disincentive is forecast to contribute to the EU’s share of global R&D expenditure falling from 32% today to 21% by 2040. The reduction equates to 2 billion Euros ($2.1 billion) in lost R&D investments each year.

An earlier report found the EU’s share of global R&D investment has already fallen over the past 20 years. Yet, EFPIA said the forecast for the next 15 years marks a legislation-driven escalation of the trend, rather than simply the continuation of the existing decline.

Other claims in the new report include a prediction that 22% of projects to develop regulatory data protection reliant medicines would no longer be economically viable in Europe. That “corresponds to an 8% drop in Europe’s total pharma innovation,” EFPIA wrote, and could cause the loss of around 50 out of 225 expected new treatments over the next 15 years. Dolon calculated such a slowdown in R&D would translate to 16 million years of life lost across the EU.

The trade group published the report the day before Medicines for Europe, which represents makers of generics, biosimilars and value added medicines, put out a statement about its own hopes for the draft pharmaceutical legislation. Following up on a letter to the European Parliament that argued the EU’s falling share of R&D is unrelated to intellectual property protection, Medicines for Europe pushed for legislative pathways for value-added medicines this week.

EFPIA Release

MedTech Europe outlines vision for a framework that fixes MDR, IVDR

MedTech Europe has set out its vision for how the EU can create the “robust, transparent, predictable and sustainable regulatory framework” promised, but in its view not delivered, by the Medical Device and In Vitro Diagnostic Regulations (MDR/IVDR).

In September 2023, the medtech trade group called for “comprehensive structural reform” of MDR and IVDR to fix frameworks it called “unpredictable, complex, slow and costly.” The call for reform reflected the view that MDR and IVDR have “structural issues” that cannot be fixed in the implementation process. Now, MedTech Europe has provided more details of the changes it wants to see.

The trade group’s vision builds on the current CE marking system by proposing reforms intended to ensure efficiency, embrace innovation and deliver effective governance. For instance, to ensure efficiency, the trade group is proposing to “considerably cut down on unnecessary bureaucracy in conformity assessment, allowing notified bodies to take a more efficient and ‘benefit-risk based’ approach.” The approach would free up notified bodies to focus “on maintaining a high standard of device safety and performance rather than on producing numerous and lengthy assessment reports,” the group wrote.

In the proposals related to innovation, MedTech Europe suggests creating “dedicated and accelerated assessment pathways within IVDR and MDR,” adopting “precertification” access models to allow early access to niche products in selected hospitals and increas the use of real-world data for product certification and postmarket clinical follow-up.

The final set of reforms covers the creation of a central structure to govern oversight of the decentralized device authorization system. MedTech Europe wants the power to authorize devices to stay with notified bodies but sees a need for a central structure to drive “everything that has to do with governance of the system.”

Press Release, Position Paper

EMA seeks feedback on clinical development of vaccines for immunocompromised people

The European Medicines Agency (EMA) has published a draft concept paper on the clinical development of vaccines in immunocompromised individuals. EMA is seeking feedback on the draft paper to inform the creation of an addendum to an existing guideline on the clinical evaluation of vaccines.

The current guideline lacks detailed guidance on the design of clinical trials to assess the safety, immunogenicity and efficacy of vaccines in immunocompromised individuals, according to EMA. Immunocompromised individuals are commonly excluded from pre-approval trials and, as such, at the time of authorization it is unknown if the dose is right for some, or all, of the heterogeneous population of patients with different types and degrees of immunosuppression. Post-authorization trials can suffer from slow enrollment or fail to deliver useful information.

EMA sees a need to provide guidance on “potentially suitable sub-populations of immunocompromised individuals for trials to improve the extrapolation of the findings to other sub-populations,” as well as to consider designing studies in immunocompromised people “that ... give some indication of alternative doses and/or regimens that could provide adequate levels of protection against infectious diseases.”

The draft concept paper is a step toward the provision of that guidance. Through the draft paper, EMA is collecting feedback on plans to attach an addendum to its existing guideline to address topics such as the “selection of immunocompromised subpopulations that are sufficiently large to be feasible for clinical trial conduct” and the design of safety and immunogenicity studies.

EMA is accepting feedback on the draft until 30 January 2024. The comments will inform the development of a draft revision to the vaccine guideline, which EMA plans to release for a six-month consultation in the second or third quarter of 2024.

Concept Paper

EMA publishes first electronic product information for human medicines in pilot project

For the first time, EMA, the Heads of Medicines Agencies and the European Commission have published electronic product information (ePI) for selected human medicines harmonized across the EU.

The publications are part of a one-year pilot project designed to assess the use of ePI, a digital format that EMA sees as opening up possibilities to share information electronically, keep it constantly updated and make it more accessible to end users. The ePIs can be viewed in the Product Lifecycle Management Portal and accessed via a public application programming interface.

EMA has published ePIs for medicines evaluated by its staff or by national authorities in Denmark, the Netherlands, Spain and Sweden. Companies involved in the pilot create and submit an ePI during their regulatory applications. The pilot, which involves 25 medicines and will end in July 2024, is intended to give EMA and its collaborators feedback on how to integrate ePIs and expand their use.

EMA Notice

Euro Roundup: EFPIA warns pharma legislation could slash global R&D over next 15 years

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