Health Data and Pharma Package Move Forward

March 21, 2024

One cannot deny that the European legislative process might be tedious and cumbersome, but there is nothing like a bit of drama in last-minute deals that we have observed in the last month. The final European Parliament (EP) plenary session of this political mandate will be on 11 April, which has made legislators work nights in Brussels recently.

Two major legislative initiatives of this political mandate of the European Institutions have moved forward – the European Health Data Space and Pharma package.

DiCE would like to see all health-related legislation being agreed upon in timeframes that allow it the care and detailed examination it needs (and policymakers to have rested fresh minds).

The pressure on the last round of talks regarding the European Health Data Space (EHDS) has led to an agreement being concluded in the early hours of the morning after hours of negotiations between the European Parliament and the Council. 

The primary goal of this law is to facilitate access to the health data of all Europeans and ultimately improve the treatment and care they receive. Commenting on the EHDS, EU Health Commissioner Stella Kyriakides said the system would “unleash the potential of health data for the development of innovative and lifesaving treatments and devices as well as for better health policy-making.”

The most contentious issue in the negotiations was the ability of patients (citizens) to control their health data (the opt-out system).

The European Parliament wanted to allow patients to control the data used for secondary purposes, meaning allowing them to opt out from the use of their anonymised or pseudonymised data for research purposes by either private or public entities. While the Member States were of the opinion that each country should decide when and how patients could opt-out.

The final agreement is a compromise, allowing citizens to opt-out from providing data for secondary purposes, unless it is for public interest research purposes, stats or policy-making.

At DiCE, we have welcomed the agreement on EHDS, hoping it will allow for badly needed harmonisation of the health data records systems across Europe and facilitate better exchange. We are pleased to hear that patients’ voices will be respected in the European Health Data Space, allowing patients to opt out of the secondary use of their health data.  Having said that, we know that many patients will appreciate the positive impact of their data in advancing research and developing new treatments. We are committed to guiding patients on the optimal use of their data to boost healthcare innovation across Europe.

Second, and even more controversial piece of legislation that has seen some last-minute progress is the so-called Pharma Package (comprising of proposal for new Directive on the medicinal products for human use and Regulation on procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency.)

The Members of the European Parliament in the ENVI Committee have managed to agree on the EP position, which should be voted on in the plenary session as well. That will open the door for negotiations between the Council, Parliament, and Commission to start. The burden of finalising the deal will probably fall on the Polish presidency in 2025.

The main discussions related to the pharma package revolve around the regulatory data protection period (exclusivity on the market), shortened by the Commission’s proposal.

Together with other organisations, DiCE believes that patients should be embedded in the regulatory process for medicines. We have also expressed our concerns about the Commission’s proposal to narrow the definition of ‘unmet medical need’ and even stratification of the term. Similarly, the introduction of proposed transferable exclusivity extension (TEE) vouchers could have unintended consequences in raised costs for healthcare systems.

We are pleased that the European Parliament has taken some of our arguments on board. At DiCE we will follow the development of this file also in the new political mandate to ensure that the pharma package provides ecosystem for innovation but primarily serves patients.

Aleksandra Kaczmarek

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