This year, the endocrine community will unite to raise public awareness of the small steps everyone can take towards better hormone health. With the European Parliament elections on the horizon, it’s also a timely opportunity to push for policy action to improve representation of endocrine health and research in national and European policies.  
 
Now in its third year, European Hormone Day is a chance to put hormones in the spotlight. ESE’s National Endocrine Societies, Patient Advisory Groups and other stakeholders will join forces on Wednesday 24 April to increase public awareness of the vital role hormones play in health and disease under the banner – #BecauseHormonesMatter.  
  
This builds on the Annex to the Milano Declaration, 10 Recommendations for Good Hormone Health, published for European Hormone Day last year. Everyone is encouraged to promote the small steps people can take to improve their hormone health. This could also include actions taken in a professional capacity to promote hormone health more generally, for example, as clinicians or policymakers.  
  
To support our partners and members in spreading the word, ESE has shared a Public Outreach Toolkit with videos, infographics and social media materials covering the 10 Recommendations mentioned above, and the four policy areas from our 2021 White Paper, including endocrine-disrupting chemicals (EDCs), cancer, obesity and rare endocrine diseases. You can choose whichever themes and activities are most relevant to your community. Translations are available in the 10 most common European languages, plus updated versions in four additional languages translated by national societies. You’ll find templates for a press release, a ready-to-use article and email signatures in the Toolkit.  
  
There’s also an updated version of the Because Hormones Matter leaflet and Awareness Days Calendar that was launched last year. We encourage everyone to use the hashtag #BecauseHormonesMatter on European Hormone Day and on other awareness days so we can boost our collective reach. We’re sharing more public-facing information and celebrating the endocrine community on our new ‘Because Hormones Matter’ Instagram account.  
  
We hope you’ll join in the campaign! Find out more by watching this video or visiting www.europeanhormoneday.org.   
  
Using European Hormone Day (EHD) to drive policy change: 
  
While EHD 2024 will focus on public awareness, improving knowledge of endocrine issues among policymakers remains important to drive change on a much larger scale. EHD is a timely opportunity to reach out to policymakers and encourage them to support health and research policies that promote endocrine health.  
  
This starts at a national level. Here are a few specific actions to consider:  
  
- Reach out to your local and national politicians – ask them to endorse the Milano Declaration and for their ongoing commitment to support health and research policies that promote hormone health.  
- Tell them about REACH and its role in tackling endocrine disruptors. 
- Tag your politicians in relevant social media posts so they can join in the conversation easily. 
- Invite policymakers to relevant online or in-person events so they can hear first-hand why hormones matter.  
- Encourage your members to reach out to their political representatives. 
- Join EHD and help spread the word to a wider audience! The more people who understand why hormones matter, the more success we will have in keeping the issue high on the political agenda.  
  
To support outreach to policymakers, ESE has also created a Policy Toolkit, which includes information and useful resources. Let’s make sure the voice of the endocrine community continues to be heard as the political landscape evolves.  
 

With Europe and the world in turmoil, the importance of the upcoming European Parliament elections cannot be underestimated. The European Parliament is likely to make a shift to the right of the political spectrum with support for far-right parties growing in multiple EU countries, with most pronounced gains driven by polling trends in Germany. The Greens, as well as the Socialists and Democrats, the second largest political group of the European Parliament, are expected to pay the political bill with a substantial loss of seats for both parties. For a full overview see POLITICO’s “Poll of Polls”, which is tracking national trends to show the seat projections for the next European Parliament.  

The question now arises; what can we as the European endocrine community expect from the newly elected European Parliament in terms of support for new health and environment policies and legislation? What will happen to key dossiers in the areas of endocrine disruptors, cancer, obesity and rare diseases? 

It is still too early to know, but history tells us that the European Parliament is traditionally very pro-health and environment and is often more progressive than the European Commission or Member States.  

The current Parliament is no exception and the position it has taken regarding the Council/Member States during its last term has, in general, been favourable for health and environment. Most recently, for example, it has included a reference to the precautionary principle in the EU Toys Safety Regulation.  

However, the Parliament, like the other EU institutions, has been facing difficulties with the adoption of key policies and legislation in this same area - and some of these are important for the endocrine community. The revision of REACH, which could be a gamechanger in addressing endocrine disruptors, faced strong resistance inside the European Parliament with some MEPs strongly opposing any major changes, which they consider to negatively affect industry and the ongoing energy transition (read more).  

This opposition has largely come from the centre-right of the political spectrum, which provides food for thought as to how to structure approaches to a possibly more right-wing oriented European Parliament in the future. This potential move away from a Parliament traditionally governed by more centralist parties creates an unprecedented situation at the EU level and is coupled with uncertainty about the implications for health and environment as well as policies in related areas.  

This is an important development to collectively consider and strengthens our conviction that we need to continue to work together closely.  

Finally, health and environment may be overshadowed by other priorities for the European Parliament and the EU in general, following the ongoing war in Ukraine, the continuous risks of mild or deeper recessions as well as other areas that a more right-centred European Parliament place a higher priority on - such as immigration.  

All in all, what we can expect from the next term of the European Parliament is a challenging environment where we will have to continue to be a united voice to keep our key topics on the political agenda.  

After some tough negotiations, the Council and European Parliament agreed on 15 March 2024, a legislative framework for a European Health Data Space (EHDS), which should make it easier for Europeans to access care throughout the EU.  

These talks were the last opportunity for the institutions to reach an agreement before the EU elections in June after several rounds of negotiations ended without a compromise deal. It will now be up to MEPs in Strasbourg to rubber-stamp the agreement in the final plenary session in April, ahead of the break for the elections in June. 

One of the main bottlenecks was around the extent to which patients should be able to opt out of their health data being re-used for research purposes. MEPs had previously taken a hard line, wanting all patients to be able to refuse access to their anonymised or pseudonymised data for all secondary purposes, including academics conducting research or pharma companies seeking to develop new products. Meanwhile, countries insisted it should be up to them at a national level to decide under which circumstances patients could opt out.
 
This issue is also important for ESE and other European medical societies. Under the umbrella of the Biomed Alliance in Europe there have been strong voices over the past year urging EU institutions to ensure that any future legislation will stimulate - and not hamper - health research, especially in the area of rare diseases where there are significant concerns the legislation will lead to biased or insufficient data.   

Under the final text, citizens will have immediate and easy access to their digital health data wherever they are in the EU. Health professionals will be able to access the medical records of a patient when required for treatment in a different Member State, allowing for evidence-based decision making. 

Secondly, patients have the right to restrict access to their personal data in electronic health records for primary use (healthcare), and they have the right to opt-out of their data being reused for research and policy making. In addition, there is a provision that states that countries may introduce stricter measures (including potentially consent-based systems) at national level for the re-use of certain types of data including genetic, genomic, molecular data, data from wellness applications and data from biobanks. Stakeholder involvement and the need for training and capacity building for healthcare professionals is also clarified. 
 
Concerns remain, for example the Standing Committee of European Doctors commented on the anticipated administrative burden for healthcare professionals. Its President Christiaan Keijzer said: "We are hopeful that the EHDS will not overburden healthcare professionals with administrative tasks, particularly for secondary use, and remain concerned about how this will work in practice, especially on funding and capacity building." 

As for health research, despite the text being a regulation directly applicable in all EU Member States, the numerous provisions enabling Members States to implement national measures in the public interest may influence the level playing field and could possibly create differences in the ease of conducting research at the national level. Only time will tell whether the EHDS is indeed the necessary step forward for health research in Europe, much will depend on the final text including the many provisions that still need to be drafted as well as its implementation at the national level.  

There have been concerns within the medical community regarding the availability of In Vitro Diagnostic Devices (IVDs) in Europe. Persistent problems with the implementation of the In Vitro Diagnostics Regulation (IVDR), insufficient certificates issued, the failure to deliver the EUDAMED database and general unpreparedness of the sector, could soon lead to the disappearance from the market of many essential IVDs as well as the related loss of international competitiveness when compared to other jurisdictions.   

In response to action spearheaded by the Biomed Alliance in Europe on behalf of its member societies, including ESE, the European Commission has now proposed an extension of the transition periods for most classes of in-vitro diagnostics and tests by 2 to 2.5 years. The transition period for in-house diagnostic tests will be extended until May 2030.

Also, when manufacturers anticipate an interruption in supply of a CE-marked devices, and where it is foreseeable this could lead to serious patient harm, manufacturers must inform competent authorities, stakeholders, health institutions and health professionals at least six months in advance. The proposal should be formally approved in the coming months, and before the European Parliament elections. 

Extended transition periods: 
Class D:                    31 December 2027 (was 26 May 2025) 
Class C:                    31 December 2028 (was 26 May 2026) 
Class B/A sterile:   31 December 2029 (was 26 May 2027) 
In-house devices:  Extended to 26 May 2030 
 
Read the statement of the Biomed Alliance in Europe on this issue here.