The European Commission proposed a new set of plans labelled “Health Package” that might bring faster access to new therapies and medical devices for patients with allergies and airways diseases. The package includes three components:
- A plan to support biotechnologies (called the Biotech Act)
- New, simpler rules for medical devices (like inhalers, ventilators, nebulisers or auto-injectors)
- A “Safe Hearts Plan” to keep everyone’s hearts healthier
The Biotech Act: speeding up the availability of new therapies
Biotechnology[1] can be the source of new treatments and therapies, more precise diagnoses and personalised medicines. However, the EU is lagging behind global competitors in this area. The new plan aims at helping scientists and companies create new treatments more easily through:
- increased funding,
- simplified regulations to fast track the availability of new treatments on the market,
- enhanced safe use of Artificial Intelligence and health data for the development of new therapies,
- and measures to protect against the misuse of biotechnologies.
For patients within our community, faster innovation and development of new therapies are of course important, but EFA highlighted that this must come with patient involvement from the early stages, better access to clinical trials and real access to treatments with timely availability across countries, and crucially, not compromising safety.
New rules for medical devices
When it comes to medical devices such as inhalers, ventilators, nebulisers or autoinjectors, current EU rules create unnecessary costs, bottlenecks and delays for patients. The new proposal includes a series of actions to reduce costs and delays. These include the simplification of rules so that medical devices can reach patients faster, the digitalisation of procedures and the monitoring of shortages of medical devices by the European Medicines Agency (EMA), with the creation of a list of critical devices.
Reduced delays in access to medical devices are important for our patients, but this shouldn’t be at the cost of safety. The balance between reducing costs and maintaining quality standards is not clear from the proposal, and patient oraganisations like us and our members can help. National Governments and the European Parliament need to ensure this is clarified in their response to the proposal.
Safe hearts plan: helping hearts stay healthy
Cardiovascular and respiratory diseases like COPD are closely linked and share risk factors such as tobacco, air pollution and respiratory infections. The new plan presents targeted measures to improve prevention, detection and treatment of cardiovascular diseases, including:
- Support to Member States in the development of national cardiovascular health plans to reduce health inequalities across countries.
- Stronger action against tobacco and smoking, with the goal of less than 5% of adults using tobacco by 2040.
- Reduce consumers’ use of ‘ultra-processed' foods, high in fat, sugar and salt,
- Protecting children from harmful advertising
- Promotion of regular physical activity
- Promotion of vaccination as a preventive measure for cardiovascular disease, including immunisation of high-risk and vulnerable groups against influenza, COVID-19, respiratory diseases and other infections.
While some important actions regarding respiratory health are included (action against tobacco and promotion of vaccination), some elements are missing, such as additional action on indoor and outdoor air pollution and the inclusion of respiratory diagnostic in primary care.
Next steps
The legislative proposals will now be submitted to the European Parliament and the Council for adoption and the work with Member States to implement the “Safe Hearts” plan will start. EFA will continue to ensure that the voice and needs of the allergy and respiratory patient community is reflected in these processes.
[1] technology that utilises biological systems, living organisms or parts of this to develop or create different products