Pharma responds to the EC’s proposed EU legislation revision

The European Commission’s (EC’s) reform of the EU pharmaceutical legislation published on 26 April 2023, adopted a proposal for a new Directive and a new Regulation. These amend and replace the existing general pharmaceutical legislation.

According to the EC, the revision is intended to:

• Ensure all EU patients can access safe, effective, and affordable medicines
• Enhance the security of medicine supply and availability, regardless of where patients live in the EU
• Continue to make Europe an attractive and innovation-friendly environment for R&D and medicine production
• Increase the environmental sustainability of medicines
• Address antimicrobial resistance (AMR) and the presence of pharmaceuticals in the environment through a One Health approach.

Several industry bodies have commented on the proposal, including the European Federation of Pharmaceutical Industries and Associations (EPFIA) and Alliance for Regenerative Medicine (ARM) as well as law firm Pinset Masons.

Pinsent Masons

Charlotte Weekes, Senior Associate at Pinsent Masons shared with EPR: “The Commission’s ambitious pharma legislation review is the first significant review of the European system since 2004.”

“It is hoped that the new legislation will achieve [its objectives] without disrupting the aspects of the system that already work well, so that industry can embrace and effect the changes while continuing the day to day business of supplying medicines,” Weekes added.  

EFPIA

Hubertus von Baumbach, President of the EFPIA welcomed moves to “future-proof Europe’s regulatory framework and stimulate research into new treatments to tackle AMR.”

Yet the EFPIA President cautioned that while the revised legislation was meant to “improve Europe’s competitiveness, the ‘net’ impact of policies set out across these proposals, in their current form, puts European competitiveness at risk.”

He summarised that the revision “weakens the attractiveness for investment in innovation and hampers European science, research and development.”

To mitigate this, he strongly recommended “a comprehensive competitiveness check is conducted on the impact of the revised pharmaceutical legislation.”

Nathalie Moll signalled that “penalising innovation if a medicine is not available in all Member States within two years is fundamentally flawed and represents an impossible target for companies.”

Thank you @BBCNews @BBCBusiness
& @VValentineNews 4 inviting @efpia 2 share our perspective on today’s monumentally important publication of #EU‘s #pharmaceutical #legislation. EU is at a xroads: will it choose 2 #closethegap with US or become reliant on the rest of the world? pic.twitter.com/bjDNE4ovUM

— Nathalie Moll (@NathalieMoll) April 26, 2023

Moll explained: “The vast majority of delays in access to new medicines are known to occur after a company has filed for pricing and reimbursement and is awaiting a decision, so that the new treatment can be made available to patients.”

“Fixing the tenfold variation in access to new medicines across the EU, requires all partners… to address the real issues…” she stated.

“If changes are not made ‘the legacy’ of [the European] Commission will be for Europe to be simply consumers of other region’s medical innovation, and European patients waiting longer than ever for the latest advances in care,” Moll determined.

Alliance for Regenerative Medicine (ARM)

The ARM shared its perspective on the revised legislation’s potential impact on the Advanced Therapy Medicinal Product (ATMP) sector.

“Our concern is that the pharma legislation is not there yet.”

ARM’s Paolo Morgese emphasizes at #EPRD23 that the current EU legislation focuses too much on mending the healthcare systems of the past and doesn’t do enough to help modernize life-changing ATMPs. pic.twitter.com/IBTlHzubY4

— Alliance for Regenerative Medicine (ARM) (@alliancerm) April 26, 2023

The industry body warned that the revision fails to build upon the Commission’s statement in its 2020 Pharmaceutical Strategy for Europe, that cell and gene therapies (CGTs) represented ‘milestones of major progress’ in healthcare.

The legislative revision is an opportunity for EU policymakers to help address the EU’s stagnation in ATMP clinical trials, according to ARM. Although it streamlines the GMO clearance process for ATMP clinical trials and makes it more specific for medicines, the proposal misses the opportunity to provide a derogation from such requirements.

The Commission’s focus on product launch in all 27 States also fails to recognise the unique nature of ATMPs, many of which are delivered in specialised treatment centres for small rare disease patient populations.

ARM acknowledged the proposal had improving on an earlier draft of the legislation, yet it noted the proposal still falls significantly short of building a sustainable future for the ATMP sector and providing access for EU patients.

Revision of the EU pharmaceutical legislation

Pharma’s next steps 

“With the proposal for the Regulation running to 185 pages, and the Directive to 184 pages, plus communications/proposals on combatting AMR, annexes, Q&As and factsheets there is a huge amount of material for pharmaceutical businesses to wade through and digest in the coming days,” Pinsent Masons’ Weekes concluded.