EU Legislative Reform

As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.

So far, calls for much needed changes to the medtech regulatory system have focused on the Medical Device Regulation. Don’t neglect the IVD Regulation, industry says.

A draft declaration to be presented to the UN General Assembly in September suggests that a “lack of regulation of over-the-counter use of antimicrobials” is one of the “drivers of antimicrobial resistance.” Industry, however, insists that misuse and over-prescription of antibiotics are the primary drivers of AMR, and is advocating for the text to be amended accordingly. 

Harmonization through increased centralization was a key theme that ran through a recent discussion between Erik Vollebregt and Tom Melvin about the MDR. Both agreed that far-reaching short-term changes are not only possible but vital.

The need for the EU to foster the development of orphan devices, intended for smaller patient populations with less commercial promise, is well documented. At last, action is starting.

Many in the EU will be taking their traditional summer break in August. They will be leaving much in the political and regulatory melting pot as they go.

Having already voiced their commitment to working to resolve issues with the implementation of the MDR and IVDR, the national competent authorities for medical devices around the EU are now also calling for a longer-term view.

A recently-published study funded by the UK National Institute for Health and Care Research finds that use of OTC nasal sprays reduces overall respiratory illness duration by about a fifth. Applied at a population level, self-care could therefore save billions in healthcare and human capital costs, as industry has pointed out elsewhere, as well as redirecting people away from antibiotic treatments that are still widely misprescribed, contributing to the fight against antimicrobial resistance. 

Marketing authorizations for OTC medicines could be rejected if their environmental risk assessments do not meet new requirements proposed within the EU pharma legislation revision. HBW Insight speaks to regulatory law experts Tine Carmeliet and Eline D'Joos to find out what you need to know about the new rules.

Dr Peter Liese and Dr Vytenis Andriukaitis, both familiar names when it comes to the regulation of medical technology in the EU, have been elected as MEPs at a time when the EU’s medtech regulations are being targeted for urgent change.

In the EU, developers struggle to tell potential investors how many trials a device might require, the potential duration or associated costs. Tom Melvin explains how to tackle these issues in a third piece* based on a recent interview.

In this final article in a series on the ongoing amendments to the pharmaceutical reform package, the Pink Sheet looks at the tougher environmental risk assessment requirements that pharma companies are likely to face in the not-too-distant future.

The EU needs to conduct a deeper, more decisive analysis of its medtech regulatory problems before it decides how to adopt elements of MEP Peter Liese’s proposed amending regulation, regulatory expert Tom Melvin told Medtech Insight.

A number of legislative proposals will be coming under scrutiny at the newly constituted European Parliament in the coming months, including the pharma reform package and draft legislation on EU-level compulsory licensing and “unitary” supplementary protection certificates.

One of the key challenges facing the Hungarian presidency of the Council of the EU in the second half of 2024 will be the proposals for an overhaul of the EU pharmaceutical legislation, which were amended by the European parliament in April. In the latest in a series of articles on progress with the reform, the Pink Sheet examines the issues surrounding the hospital exemption for advanced therapies.

EU policymakers have the chance to adopt legislation that establishes a strong and predictable framework of incentives for R&D into new medicines, particularly those that require riskier investments, says CSL Behring’s Lutz Bonacker.

As well as differences of opinion over the “incentives” part of the EU legislative overhaul, the latest meeting of health ministers revealed uncertainties about whether to use incentives or obligations to improve medicines access and how to define “unmet medical needs."

In a sign of difficult negotiations to come on the European Commission’s pharma reform package, the presidency of the Council of the EU has drawn up its own set of proposals on regulatory data protection and market exclusivity that differ in several respects from those of the commission and the European Parliament.

The European Parliament could have helped to stimulate R&D into new drugs for rare diseases if it had not stuck so closely to the European Commission’s original proposals on orphan exclusivity periods, say Baker McKenzie lawyers Els Janssens, Julia Gillert, Magda Tovar and Olha Sviatenka.