Belgian MEP Sommen says ‘predictability is vital' from pharma trilogue

Euractiv

09-07-2025

Belgian MEP Liesbet Sommen (EPP, CD&V) is urging swift progress on the EU pharmaceutical reform as trilogue negotiations between the Parliament, Council and Commission begin.
For Sommen, political momentum must now translate into concrete results for patients, and predictability for patients and companies is vital, she said.
'What matters to me is the outcome,' she said. 'Now that the trilogues can start, I hope good progress will be made quickly.'
Her remarks follow the announcement by Health Commissioner Olivér Várhelyi of the EU Life Sciences Strategy on 2 July.
In a post on X, Várhelyi outlined his legislative priorities, naming the conclusion of the pharma package and the Critical Medicines Act as top priorities of what he called a 'health package by the end of 2025.'
Sommen believes the legislative institutions are not too far apart on the core issues, a rare advantage that should be used to accelerate negotiations.
'The good news is that the positions on several sensitive issues are not too far apart,' she noted. 'The details will matter, of course, but this could help speed up the negotiations.'
At the same time, she warned that broader geopolitical and health system pressures leave little room for delay.
'Our pharmaceutical sector is under pressure due to the international context, while the medical community and patients urgently need innovative medicines,' Sommen said, adding: 'Accessibility and affordability for the patient must always come first; we don't have time to waste.' Rethinking the access incentive
One of the most contentious elements of the Commission's original proposal was the so-called access incentive, which would grant up to two extra years of regulatory data protection (RDP) to companies that made their product available in all 27 EU countries within two years.
The Parliament chose to remove this mechanism altogether, replacing it with an obligation to respond to pricing and reimbursement requests. The Council, by contrast, retained a softer version, giving member states the right to request access and requiring companies to supply within four years.
Sommen supports the Parliament's decision to drop the original incentive, which she believes was too rigid. But she insists the broader goal of equal access across the EU remains essential, especially for smaller markets like Belgium.
'In theory, that access incentive sounded promising,' she said. 'That should be the starting point of this revision: how do we ensure equal access for all Member States?'
She pointed to the potential unintended consequences of the Commission's model.
'What if a company wants to make a medicine available in all 27 countries, but one country refuses? Sometimes it's better to have a clear baseline framework for data protection, with incentives where needed.'
Predictability, she added, is vital not just for companies but also for national health systems and patients.
'That kind of predictability benefits everyone: the companies, the member states and the patients.' Antibiotic incentives under negotiation
Another unresolved issue is how to incentivise the development of new antibiotics in the face of growing antimicrobial resistance (AMR).
The Council favours a limited version of transferable exclusivity vouchers (TEVs), a reward mechanism allowing companies to extend the market exclusivity of another product. Meanwhile, Parliament has proposed alternatives, such as milestone payments and subscription models.
Sommen said all these approaches remain on the table.
'It's true that vouchers remain part of the negotiations,' she explained. 'In the European Parliament, we examined other options, but we ultimately agreed to consider the voucher mechanism in a certain form.'
However, she stressed that any reward system must be closely monitored and carefully controlled.
'The reality is we need to invest more in the fight against antimicrobial resistance. That requires new antibiotics, so we need to be open to systems that can incentivise additional scientific research, always with a critical eye.'
'What we must absolutely not do is give a blank cheque that allows other medicines to be sold at high prices for longer. That is unacceptable.'
She said Parliament and Council had both introduced safeguards to avoid such outcomes.
'It's now up to the negotiators to find the right system. Once again, for me, the patient must be central. It's about availability and affordability.' Focus on real innovation for unmet medical needs
Parliament had also proposed introducing a 'high unmet medical need' (HUMN) designation for products targeting rare or poorly treatable conditions, with additional regulatory incentives. However, the Council dropped the HUMN label in its final negotiating position.
Sommen believes the concept remains valuable, even if its formal designation is no longer part of the proposal.
'The criterion of 'high unmet medical need' can certainly add value,' she said. 'It's important that, alongside conventional medicines, we continue to invest in scientific research into innovative treatments for diseases that remain difficult to treat.'
She cautioned against a system that rewards only marginal improvements.
'We must not move toward a system where new medicines come to market that make little difference compared to existing treatments.'
For Sommen, real innovation should be targeted where it matters most.
'I am convinced that governments have a role to play in ensuring sufficient research into rare diseases. Truly patient-centred policy means not just producing more medicines, but the right medicines for those who need them most.' Danish Presidency takes the lead
Trilogue negotiations will be chaired by the Danish EU Presidency, which is under pressure to finalise the deal by the end of 2025. With Várhelyi's end-of-2025 deadline in sight, the window for political agreement is narrowing. For Sommen, success will not be measured by institutional wins but by results on the ground.
[Edited by Vasiliki Angouridi, Brian Maguire]