Euro Roundup: European Commission proposes streamlining regulations to boost biomanufacturing

The European Commission is set to assess how to streamline regulatory pathways for the biotechnology and biomanufacturing sector as part of a broader push to find ways to boost the industry. Officials see the assessment as a potential precursor to an EU Biotech Act.

“Innovative biotechnologies and products may encounter regulatory obstacles at both member state and EU levels when entering the market,” the Commission wrote communication sent to the other EU bodies on 20 March. “Developers of biotech health products have difficulties in navigating the complex EU and national-level regulatory environment and the intrinsic complexity characterizing those innovative treatments.”

The Commission cited the existing regulatory framework for developing and using biotech-based medicinal products as an example of the complexity and shortcomings of regulation today. Depending on the nature of their products, companies may need to comply with multiple complex pieces of legislation “covering medicinal products, advanced therapies, medical devices and in vitro diagnostics, substances of human origin, genetically modified organisms and clinical trials, both at the national and EU level.”

Therefore, the Commission plans to “assess how EU legislation and its implementation could be further streamlined to reduce any fragmentation, explore potential simplification and shorten the time for biotech innovations to reach the market.” Officials will also look at “regulatory obstacles that arise at national or other governance levels which impede an effective single market.”

The Commission “will map key current industrial bio-based value chains, analyze the regulatory framework and the impact of relevant legislation and thereby lay the foundations for a possible EU Biotech Act.” Officials hope to identify “targeted simplifications to the regulatory framework.” The focus is on harmonized requirements for low-risk biotechnologies and simpler approval for certain categories.

Officials noted the interface between the possible EU Biotech Act and existing pieces of legislation. The Commission said the planned reforms of the EU pharma legislation include provisions “to ensure that the EU regulatory system is flexible enough to accommodate new innovative biotechnological medicines that are safe and effective.” Officials also discussed the Clinical Trial Regulation and vowed to start a study of its implementation and impact this year. The Commission will consider if the law needs changing.

EFPIA, a trade group representing large pharma companies, welcomed the Commission’s focus on biotech and said the communication “rightly references the importance” of simplifying existing regulatory frameworks.

Press Release, EFPIA Statement

Council and Parliament make breakthrough on European Health Data Space proposals

The European Council and Parliament have reached a provisional agreement on the proposed European Health Data Space (EHDS).

In recent months, negotiators have worked to reach an agreement on changes to the Commission’s plan for the EHDS, a project intended to make it easier to access and exchange health data across borders. Industry groups have raised concerns about aspects of the proposals, warning that the addition of an opt-out mechanism and other changes could undermine the initiative.

The Council and Parliament made a breakthrough last week. The provisional agreement features several key changes to the Commission’s proposal, including the addition of an option for member states to “allow patients to opt-out on the use of their health data being accessed.”

The opt-out mechanism can prevent access by healthcare professionals and by other groups to inform health research and policymaking. Data used “for purposes of public interest, policy making, statistics and research purposes in the public interest” is excluded from the opt-out option. If patients choose to restrict information, healthcare professionals will only be able to see it “in situations of vital interest.”

Member states can also impose “stricter measures governing access to certain kinds of sensitive data, such as genetic data, for research purposes” and establish “trusted data holders.” The use of trusted data holders that can securely process requests for access to health data is intended to reduce administrative burdens.

The Council and Parliament will now endorse the provisional EHDS agreement. The regulation will come into force 20 days after the text is formally adopted and published in the EU’s Official Journal.

Press Release

Off-patent drugmakers welcome ‘imperfect’ compromise on pharmaceutical legislation

Medicines for Europe has hailed the “many improvements” adopted in the latest agreement on the planned EU pharmaceutical legislation.

This week, the Parliament’s health committee voted in favor of a compromise position on the planned EU pharma directive and regulation. Medicines for Europe, which represents off-patent drug companies, said that, although the compromise is “imperfect,” it “accelerates much-needed reform” and features many improvements.

The trade group listed the clarification of the harmonized Bolar provision as an improvement, noting that the tweaks could encourage the production of active pharmaceutical ingredients and prevent delays to the availability of generic and biosimilar medicines. Medicines for Europe also highlighted the use of an antimicrobial voucher as a “last resort” as a positive but still wants to see a “guaranteed reserve.”

Parts of the legislation on shortages and the environment have been improved too, the trade group said, but “there is still a lot of progress needed to develop a true shortage prevention policy and to maintain a coherent risk/benefit policy for medicines authorizations.”

EFPIA also noted “pragmatic improvements to the initial text” but remains concerned that the reforms will make the EU less competitive and less attractive as a location for R&D. The trade group contends companies are “highly likely” to move R&D and other activities “to areas with more ambitious life science strategies” if the changes take effect.

Press Release, EFPIA Statement

MedTech Europe calls for clarity on aspects of plan to streamline chemical assessments

MedTech Europe has welcomed proposals to streamline the assessment of chemicals in the EU but called for clarifications on several points.

The medtech trade group made the comments in response to the “One Substance, One Assessment” package of legislative proposals published late last year. Through the package, the EU wants to bring a streamlined, harmonized approach to the assessment of chemicals. The package could help to reduce animal testing and prevent the duplication of activities, the trade group said.

MedTech Europe sees benefits to involving the European Chemicals Agency (ECHA) in the Restriction of Hazardous Substances in Electrical and Electronic Equipment but emphasizes it must have the expertise to handle the new responsibilities. The proposals include targeted amendments to the Medical Devices Regulation that the trade group contends will affect the expertise that ECHA needs to possess.

The industry group wants officials to consider the additional resources and budget that ECHA will need as part of a formal impact assessment. According to MedTech Europe, ECHA is “already overburdened,” and there are concerns about “resource efficiency, effectiveness and accuracy of evaluation outcomes.”

Press Release

Other news

The European Medicines Agency (EMA) has shared a guide to registering or changing an EU Qualified Person for Pharmacovigilance (QPPV). The document describes the steps organizations need to take when setting up a QPPV for the first time and when an existing QPPV leaves their position. EMA Guide

Euro Roundup: European Commission proposes streamlining regulations to boost biomanufacturing

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