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New parliament needs to finalise pharma package, begin controversial work on health determinants

3 months ago 16

This article is part of our special report Key unfinished files EU Parliament inherits in the next term.

The Ursula von der Leyen Commission started with an ambitious programme in the field of health. Health Commissioner Kyriakides was tasked with putting forward Europe’s Beating Cancer Plan, improving the supply of affordable medicines, creating a European Health Data Space, implementing the One Health Action Plan, along with working on food safety and animal welfare. 

The EU’s ability to act in the field of health was transformed by the COVID-19 pandemic. Those changes included greater powers in health and civil protection, the creation of a new agency, the EU’s Health Emergency Preparedness and Response Authority (HERA), as well as health being given greater recognition in the EU’s fiscal governance and substantial funding through the Recovery and Resilience Fund (€43 billion). 

Much has been achieved, as summarised in the recent communication on the European Health Union. But two major areas will spill onto the desks of the next European Parliament: the pharma package and delayed proposals on health determinants of; tobacco, alcohol, and dietary proposals. 

The main dossier that remains pending is the Pharma Package. 

Pharmaceutical Package

The ‘Pharma Package’ consists of two proposals (a regulation and a directive) to revise the EU’s existing legislation. The aim is to foster innovation and enhance the supply of medicines, while also improving access and affordability of medicines. It is the first revision of these laws in 20 years. 

The package attempts to strike a balance between incentivising research into medicines and making them more affordable. In its first reading, the Parliament supported stronger incentives with extended periods of market protection and regulatory data protection, for certain medicines. The package was adopted by a large majority at first reading

The Council Working Party on Pharmaceuticals and Medical Devices have only just started to work through this large and highly technical package. 

There are divisions within industry and between member states. Producers of generic and biosimilar medicines argue that restricted access to the market is costly for public administrations, while the wider pharma sector argues that market protection is necessary to incentivise the huge investment required for drug development. 

The Hungarian Presidency, which starts in July, will want to make progress on reaching a consolidated Council position, but diplomatic sources tell Euractiv that this complicated package is likely to continue well into 2025. 

Given the broad cross-party support for the parliament’s position, we don’t anticipate that a new parliament will change its views in its new mandate.

Health determinants

Europe’s Beating Cancer Plan contained a number of proposals for legal initiatives to tackle risk factors that contribute to the risk of cancer. Reviews of taxation legislation linked to alcohol and tobacco have all been delayed, as have proposals on alcohol and nutritional labelling. 

A more right-wing parliament may be opposed to legal measures addressing these issues, that are proving highly contentious and engendering strongly opposing views between industry and NGOs. 

[Edited by Rajnish Singh]

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