Proposals for changes to EU pharma legislation raise concerns for SMEs

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DDW’s Diana Spencer explores the European Commission’s proposed changes to EU pharmaceutical legislation, the reaction from industry and possible impact on smaller companies.

The European Commission (EC) has proposed the largest reform to the EU’s pharmaceutical legislation in over 20 years.

The EC says the revisions will make the system more agile, flexible, and adapted to the needs of citizens and businesses across the EU, as well as making medicines more available, accessible and affordable.

It is also hoped the reforms will support innovation and boost the competitiveness and attractiveness of the EU pharmaceutical industry, while promoting higher environmental standards.

The Commission states that, currently, there are significant gaps in addressing unmet medical needs, rare diseases and antimicrobial resistance (AMR). High prices for innovative treatments and shortages of medicines remain an important concern for patients and healthcare systems.

Key elements of the proposal

Better access to medicines

New incentives are designed to encourage companies to make their medicines available to patients in all EU countries and develop products that address unmet medical needs. The EC also says that earlier availability of generic and biosimilar medicines will be facilitated, and market authorisation procedures simplified.

Speeding up procedures

The reform hopes to create an innovation-friendly regulatory environment, with the European Medicines Agency (EMA) providing better early regulatory and scientific support. EMA authorisation procedures will now take 180 days, down from 210, while and the Commission will have 46 days to authorise drugs, down from 67. The EC also proposes to abolish (in most cases) marketing authorisation renewal and introduce simpler procedures for generic medicines.

Changes to regulatory protection period

Instead of the current 10, the proposals suggest a minimum period of regulatory protection of eight years, but with possible extension to up to 12 years for innovative medicines. The protection can be extended if medicines are launched in all Member States, if they address unmet medical needs, if comparative clinical trials are conducted, or if a new therapeutic indication is developed. It is hoped that this will encourage companies to focus on the patients’ greatest needs and to ensure more equitable patient access to medicines across the EU.

Addressing shortages of medicines and ensuring security of supply

There will be new requirements for monitoring of shortages of medicines by national authorities and companies will be required to report shortages and withdrawals of medicines earlier. An EU-wide list of critical medicines will be established, and supply chain vulnerabilities of these medicines will be assessed, with specific recommendations on measures to be taken by companies and other supply chain stakeholders. In addition, the Commission could adopt legally binding measures to strengthen security of supply of specific critical medicines.

Stronger protection of the environment

The EC says that better enforcement of current environmental requirements will limit the potential negative consequences of medicines on the environment and public health.

Tackling antimicrobial resistance (AMR)

The reform offers incentives through transferable vouchers to companies that invest in novel antimicrobials that can treat resistant pathogens. Measures and targets for prudent use of antimicrobials, including adapted packaging and prescription requirement, will also be introduced.

Response from the industry

There has been a predictably mixed reaction to the proposals from the pharmaceutical industry.

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) described the proposals as “much-needed regulatory changes for a future-oriented system”, but said that they raised concerns for small and mid-sized innovative biopharmaceutical companies. They argue that the proposal introduces more risk and unpredictability into the system while reducing incentives for innovation and investment, which will negatively impact patient access in the long term.

The group welcomed the simplified and reduced structure of the EMA and the strengthened scientific advice and regulatory support of EMA for Orphan Medicinal Products (OMPs) and small and mid-sized companies.

EUCOPE Secretary-General Alexander Natz said: “An attractive and predictable EU pharmaceutical ecosystem is crucial for small and mid-sized companies to continue bringing innovation to Europe. The Commission’s revision includes troubling proposals, such as the introduction of (High) Unmet Medical Need, which risk reducing the EU’s global competitiveness in life sciences, thereby limiting the development and availability of innovative therapies.”

The European Federation of Pharmaceutical Industries and Associations (EFPIA)

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has responded more strongly that the new proposals will ‘weaken’ the EU’s intellectual property framework and bring considerable concerns and uncertainty for companies operating in the region.

The EFPIA has countered that it would like to see greater focus on rare diseases and the removal of undefined concepts such as High Unmet Medical Need (HUMN). It also suggested that it is unfeasible to expect small and mid-sized companies to launch their product in all 27 Member States in a given time frame.

It says that the EC’s proposal for an EU-level compulsory license, which could be used to broadly abrogate the IP rights of innovators, provokes concerns for the stability of the IP regime in Europe and appears to disregard lessons learned from the Covid-19 pandemic response.

Nathalie Moll, Director General, EFPIA, said: “Protecting the EU’s intellectual property framework could not be more important if we are to close the investment gap between Europe, the US and increasingly China and continue to offer patients the best possible treatments. Yet we are seeing multiple proposals emerging from the European Commission in the pharmaceutical legislation and patent package which tend towards the opposite.

“Europe’s ability to lead the world in researching, developing and manufacturing vaccines for Covid-19 was built on a solid foundation of strong intellectual property and a diverse eco-system of research-based companies and institutions working tirelessly together. We need to decide if we want a competitive Europe with strong science or to become importers of medical science and accept the risks that come with this.”

The Alliance for Regenerative Medicine (ARM)

The Alliance for Regenerative Medicine (ARM) has cautioned that the European Commission’s proposed revision of the pharmaceutical legislation “remains focused on the conventional medicines of the past rather than the Advanced Therapy Medicinal Products (ATMPs) of the future”.

The Alliance argues that the revision is an opportunity for EU policymakers to help address the EU’s stagnation in ATMP clinical trials, but it “still falls significantly short of building a sustainable future for the ATMP sector and providing access for EU patients”.

It says that the Commission’s focus on product launch in all 27 EU member states fails to recognise the unique nature of ATMPs, many of which are delivered in specialised treatment centres for small, rare disease patient populations.

The legislative proposals will now be submitted to the European Parliament and the Council.

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