Pharma package revisions embed a European solidarity mechanism, says Belgian MEP Ries
Patients with rare diseases will be clear beneficiaries of the European Parliament’s vote on the revised pharmaceutical legislation, says Belgian MEP Frédérique Ries. The pharma package revisions will also embed a European solidarity mechanism, capitalising on European added value.
On 10 April, the European Parliament endorsed a series of far-reaching measures aimed at making medicines more available, accessible, and affordable; while supporting the competitiveness and attractiveness of the EU pharmaceutical industry, all with higher environmental standards.
“With this revised legislation, I am really hopeful for what’s ahead for Europe. We’re aiming to make healthcare better for everyone by ensuring that treatments are easy to get, affordable, and available no matter where you live,” Belgian MEP Frédérique Ries told Euractiv. She said her priority is to make sure that everyone, especially people with rare diseases who often have a harder time finding help, can get the latest and best treatments.
“It’s all about making sure that innovations in medicine benefit us all and that no one is left behind. It’s a big step forward in making sure everyone gets the care they need,” she said.
Biopharmaceutical company MSD commended the efforts of MEP Ries. “As the shadow rapporteur for the regulation of medical products for human use, she has demonstrated unwavering commitment to patient health and innovation,” David Earnshaw, Head of the MSD Brussels Policy Centre, told Euractiv.
Protecting the vulnerable
The regulation revises the incentive system for the development of new orphan drugs, essential for encouraging innovation for these often neglected diseases. The agreement reached by Parliament enhances the Commission’s proposal and grants nine years of market exclusivity to reward innovative treatments and eleven years for those addressing highly unmet needs.
While some diseases are rare, the patients are numerous. There are between 6,000 and 8,000 rare diseases affecting a total of 6 to 8% of Belgians, or about 700,000 Belgians – and over 30 million people in Europe. A disease is considered “rare” when it affects fewer than one person in 2000.
Ries emphasised that she “(…) wanted negotiators to pay special attention to the most vulnerable, the 30 million Europeans living with a rare disease who deserve to be finally supported by a comprehensive European Rare Diseases Plan.”
She urged the European Union to recognise the reality, that 95% of rare diseases still have no treatment. “Under these conditions, any medicine targeting one of these neglected diseases must receive maximum incentives and support from the EU. The other challenge remains the accessibility of medicines across the Union; Member States must take their responsibilities.”
“Above all, we are embedding a European solidarity mechanism into law,” she said, adding, “In short, we are capitalising on what constitutes European added value.”
Addressing medicines shortages
Of paramount concern is the persistent issue of medicine shortages plaguing Europe and Belgium. According to data from the Federal Agency for Medicines and Health Products (AFMPS), 3,596 medicines were reported as unavailable in Belgium in 2023, with a 54-day average market absence.
This figure has been steadily increasing for several years (between 2022 and 2023, the increase was 20%). Production problems, dependence on concentrated global supply chains, and low profitability of certain essential medicines; shortages are a complex and multifactorial issue with serious consequences for European patients.
“Shortages have become endemic in Europe, posing a serious threat to the daily health of Europeans and our independence,” said Ries. To address this, she said the EP is imposing the development of a shortage prevention plan for each medicine, with particular attention to so-called critical medicines and active monitoring of national measures to avoid unintentional shortages in other Member States.
Fighting antimicrobial resistance
The legislative package underscores a concerted effort to combat the scourge of antimicrobial resistance (AMR), a looming global health crisis. AMR is responsible for an alarming 1.27 million deaths annually worldwide. Ries stressed the urgent need for decisive action: “Antimicrobial resistance is wreaking havoc, with 35,000 deaths per year in the European Union, and poses a real risk of uncontrollable pandemics.”
The proposed measures equip the EU with a robust toolkit to expedite the development of priority antimicrobials, fortifying Europe’s defences against this silent pandemic.
In the meantime, discussions continue on the Council side, expected to reach an agreement on some of the key issues by the end of the Belgian Presidency.
Following the vote, Bristol-Myers Squibb (BMS) emphasised to Euractiv the need for governments to proactively future-proof the EU’s innovation environment.
“As they deliberate the proposal from the European Commission, governments should prioritise maintaining the Research Data Protection (RDP) period at eight years and modernising the regulatory framework,” Emmanuel Chantelot, Vice President, Head of International Policy & Government Affairs at Bristol-Myers Squibb told Euractiv.
“Innovators like BMS should have unwavering confidence in the EU as a prime investment hub across the entire lifecycle of medicines (…) The responsibility of optimising the future innovation policy environment now rests with the EU’s national politicians,” Chantelot said.
[By Nicole Verbeeck, Edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]
Read more with Euractiv
