The DG Internal Policies of the European Commission has just released a report addressing the outlook on the different fields of healthcare; the document was a specific request of the Committee on the Environment, Public Health and Food Safety of the EU Parliament (ENVI) and it aims to shape the public health agenda during the new legislature.
Despite great investments in healthcare (roughly 10% of the EU GDP), many Europeans still suffer for health needs, especially in the more vulnerable parts of the population. The report takes WHO’s definition of health, i.e. “a state of complete physical, mental and social well-being”, upon which the absence of disease is not enough to guarantee a good health condition. “The aim of public health policy is to create the enabling conditions for people to maintain their health, improve health and well-being, and prevent ill-health or the deterioration of their health”, states the report as a declaration of principles. The document analyses the different lines of action already ongoing or among the priorities listed in the Mission Letter to the Commissioner-designate for Health (Stella Kyriakides). We briefly address the main topics related to the pharmaceutical industry.
The determinants of health
Many are the factors impacting on health status, that are discussed in detail by the report; it also refers to the “Health in All Policies” (HiAP) approach, according to which health impacts should be considered in all relevant policy processes.
Social, or socio-economic, determinants of health relate to the conditions people live and work: income, employment and education are important points to be considered, also with relation to inequalities and inequities.
Environmental determinants of health are very wide group of different factors – from pollution to occupational health, from climate change to urban environments, up to water quality and noise levels – that may act at a double level both on human and environmental health.
The organisation of health systems and their resources are another important determinant to deliver “quality services to all people, when and where they need them” and without causing financial problems.
Activities run by the private sector refer to the commercial determinants of health; roles and rules used to run these activities may influence health, as for example different corporate practices that have been identified to have negative implications, says the report.
Individual determinants of health are listed as the last factor, and it includes biological factors and lifestyle.
Affordable and innovative medicines
The supply of affordable medicines and an innovative pharmaceutical industry should be a major priority for the future Health Commissioner, states the report.
Sustainability of innovative medicines is quite an old issue still waiting for real solutions. Several legislative measures have been already undertaken at the EU level to facilitate access, from the 2017 Resolution on options for improving access to the Council Conclusions on strengthening the balance in the EU’s pharmaceutical systems (2016). BeNeLuxAI and the Valletta Declaration Group of countries are examples of collaborations at the member State level aimed to better negotiate with the corporates the price of medicinal products. The SPC Regulation may also be of help in improving access, when it will fully come into force in 2022.
Another hot issue waiting for solution is shortage of medicines; EMA Task Force is still working, after the publication of a guidance on the detection and notification of shortages and good practice indications to communicate with the public.
On the side of innovative products, a Staff Working document on medicines for rare diseases is expected to be published by the Commission by the end of 2019. Personalised medicines is closely linked to digitalisation, to better characterise individuals’ phenotypes and genotypes, to identify the best therapeutic options or to prevent the insurgence of the disease. Strictly related is also genomics, which may greatly impact on diagnosis and therapy. The report underlines that genomics policy still falls under the EU Digital Single Market. “Another challenge is to ensure that developments and research demands in personalised medicine and genomics do not overshadow attention to existing effective health interventions, or compromise individual rights”, is the warning of the document.
Other relevant indications
The implementation of the Clinical Trials Regulation in 2020, new agreements and guidelines on GMP and GDP, international cooperation and falsified medicines are among the other topics to be monitored in the incoming years.
Guido Rasi will close its mandate as EMA’s executive director in November 2020. While waiting for his substitute, the Agency is also called to recognise the remarks made by the European Ombudsman on relationship between EMA and pharmaceutical companies. “It remains to be seen which of the Ombudsman’s recommendations will be taken on board by the Agency”, is the comment of the report.
The new Medical Devices Regulation will entry into force on May 2020; the report questions about the current number of notified bodies to be enough to ensure the availability of devices. An issue to be closely monitored, as well as the implementation of the regulation; devices will now fall under the competences of the Health Directorate of the new Commission.
Many suggestions on how to improve the Cross-Border Healthcare directive have been advanced by the European Court of Auditors and the EU Parliament, and are waiting for decisions at the Commission level.