The challenge that the European Commission set itself up for in revising the EU’s Pharmaceutical Legislation (namely Directive 2001/83/EC1 and Regulation (EC) No 726/20042) couldn’t be more difficult.

The proposed revisions must balance the need for affordable and accessible medicines, while ensuring the EU remains an innovative and competitive market for the healthcare sector.

As Commissioner Stella Kyriakides put it, the new rules should be ‘patient-centred, industry-friendly.’

A leaked version of the Commission’s proposal was circulated earlier this year. By the time you read this article, the European Commission should have released the proposal (delayed several times this spring; the due date of 26 April).

At DiCE, we have been following the discussions and reflecting on the changes it could bring to cancer patients.

In accordance with the European Commission’s objectives, the reformed EU legislation on pharmaceuticals should:

• Ensure patient access to innovative and affordable medicinal products.
• Support innovation, including areas of unmet therapeutic needs.
• Improve the security of supply chains.
• Adapting to scientific and technological developments.
• Reducing excessive regulatory burdens.

Looking at the impact assessment from the summer of last year and the leaked documents, DiCE has some areas of concern.

Despite the best intentions, some proposals might have unintended consequences for patients. They revolve mainly around two aspects:

1. Access to affordable medicines

Despite the widespread belief, access to medicines is influenced by more than financial aspects. DiCE believes better access is a shared responsibility between industry, national authorities and European institutions.

An obligation to launch products in 27 Member States within two years might seem like an easy solution to the problem.

But as already has been the case with other EU regulations, Members States need more capacity to accommodate the new regulatory framework, which might unintentionally hamper access.

Instead of focusing on obligations, European Institutions should focus on support to Member States, especially regarding the exchange of best practices on transparency and national reimbursement and launch processes.

Member States need to have sufficient capacity and competent authorities to streamline national pricing and reimbursement procedures. To that end, an initiative already operating called Beneluxa might serve as a good practice example to be supported across the EU.

2. Incentives for innovation

For many patients that DiCE represents, innovation is more than just a buzzword.

Innovation is a lifesaver for them, access to clinical trials has already been a long-standing problem in the EU. We hope that the revision of pharmaceutical legislation will not further worsen the outlook.

For digestive cancer patients, Europe has to be at the forefront of global innovation and continue developing cutting-edge medicines.

With a particular concern, we noted that some stakeholders deem the forthcoming changes a potential deal breaker for continuing their businesses in Europe.

The EU Pharmaceutical Strategy, combined with the changes in the IP Action Plan, might result in scaling back of the exclusivities granted to new medicines. However, we sincerely hope that the European Institutions will find a sufficient compromise to reward innovation and promote R&D in Europe.

Looking at the leaked text, we noted the change in the definition of ‘unmet medical needs’ and an idea even to stratify these needs. Although we understand the logic and good intentions behind this change, this might result in less innovation in areas such as digestive cancers.

The proposition that if there is an existing treatment, the new treatment, to be eligible for a better exclusivity scheme, must cure the disease satisfactorily is a higher bar than currently.  

Advances in cancer, and especially in digestive cancers, are made incrementally. DiCE’s concern is that this approach will stall the development of some digestive cancer treatments. In the area of digestive cancers, treatment to attain the goal of curing a disease might be almost impossible. It is highly likely that this approach concerning ‘unmet medical needs’ will disincentivise progress in digestive cancers.

The idea floated in the leaked versions of ‘transferable exclusivity vouchers’, although seemingly promoting the development of new AMR drugs (or other medicines with societal need but little commercial interest), might come at a detriment to other disease areas.

One could envisage that from a commercial perspective, a company receiving an exclusivity voucher (for the development of a drug of low commercial value but high societal value) would use that ‘voucher of exclusivity’ (monopoly on selling another drug) solely on one of its most lucrative drugs. This could adversely impact diseases such as cancer, where drugs are expensive. Consequently, this voucher scheme could have a very high price tag for Member States’ healthcare budgets.

Although looking at the political calendar (European elections in May 2024), one might not see the results of the revision of the EU Pharmaceutical Legislation until 2025. These changes will eventually trickle down to patients across Europe.

It is our hope and we will work towards ensuring that unintended negative consequences for digestive cancer patients will be minimal.

Author:
Ruel Jacob