Update: Health Data Space and lung cancer screening – EAPM presses forward with the essentials

Brussels, 2 June, 2022: On 7 June, the European Alliance for Personalised Medicine (EAPM) is organizing an EU expert panel regarding the new proposal on the EU Health Data Space, and is also promoting absolutely essential moves on lung cancer screening, writes EAPM Executive Director Dr. Denis Horgan.

European Health Data Space

Deriving the full benefits of the European Health Data Space will depend as never before on Europe making a conscious decision to act in concert, with the right legislation and the right policy decisions, so as to take the chance that is on offer. Success requires that data can flow more freely, rather than being trapped in traditional silos or constrained by artificial borders.

This will require buy-in by EU and national policymakers, by health authorities at all levels, and by stakeholders – patients and citizens – who stand to gain most, and who are also determinant in how far further benefits will be conferred on future generations of Europeans. 

Individuals are both the sources for and the beneficiaries of this wealth of data. And for once, it is individuals who are in a position to influence the outcome. In very real terms, this time the future is in their hands.

The EAPM Expert Panel Event will take place on 7 June, bringing together policymakers with thought leaders from health care, academia, industry, and patient organizations, to learn from each other and discuss the current state of play and a joint approach forward to developing widespread development and adoption best practice.

Registration is open– click here to register and for the agenda, please click here.

The case for lung cancer screening

There is still some question whether member states will support the inclusion of lung cancer screening in the revision of the update of the Council Recommendation of 2 December 2003 on cancer screening.   Although the scientific community has recommended this and there is political support at the Parliament level as well as among the patient group, some member states are not completely convinced of the necessity of this.

Now is the time to persuade policymakers across the EU that this is an urgent societal need.

And that means that it’s a political need.

Lung cancer screening is needed now.  This has been the consensus since EAPM organised the first Presidency Conference on Lung Cancer Screening back in 2017 during the Maltese Presidency of the European Council. 

It is at the very least surprising that the biggest cancer killer of all does not have a solid set of screening guidelines across Europe. Lung cancer is one of the biggest killers on the planet. And while there is, of course, a well-documented direct connection between the disease and smoking, non-smokers also get lung cancer.

We are all aware that by far the best way to reduce numbers of lung cancer patients is to persuade smokers to stop. But not all sufferers are, or have ever been, smokers.

Lung cancer is a deadly numbers game. Figures show that lung cancer causes almost 1.6 million deaths each year worldwide, representing almost one-fifth of all cancer deaths. 

In its early stages, lung cancer has a very good prognosis over a five-year period. But this becomes much poorer in later stages, because treatment by then has little effect on preventing deaths.

It is now well recognized from multiple screening trials that if early stage lung cancers are identified and surgically resected, the patient has a very good five year survival.

Many experts believe that the EU should put guidelines in place that will allow member states to set-up quality assured early detection programmes for lung cancer, and that there is a need for increased public-private partnerships to do this. 

Europe’s health systems need to adapt quickly to allow patients and citizens to benefit from early diagnosis of lung cancer and reduce mortality for this lethal disease.

This will be an issue that EAPM will be following up in the months ahead with colleagues at Council level as well as with other institutional partners. 

In-vitro diagnostics

New EU rules governing in-vitro diagnostics (IVD) have now come into effect. The IVD Regulation supersedes the rules of a 20-year-old directive with the aim of upgrading assessments and certification for medical tests to ensure they conform to performance thresholds, and that they are safe and of a high quality. The IVDR also introduces a new system to identify each test available in Europe, through registration in a central database called Eudamed. The regulation entered into force in May 2017, alongside its sister Medical Devices Regulation. While the latter came into effect in May last year, implementation of IVDR has been delayed, in part due to the pandemic. 

IVD devices classed as higher risk, such as HIV or hepatitis tests (class D) and certain influenza tests (class C), have a transition period until May 2025 and 2026, respectively, while lower-risk tests such as class B and A sterile devices, have a transition period until May 2027.

New in-vitro diagnostic regulation could catch Europe off guard

The coronavirus pandemic shone a light on the importance of high-quality and effective medical tests.

Now, new rules are taking effect across Europe today (2 June) that aim to ensure all marketed in-vitro diagnostics are registered, traceable and meet high performance and quality thresholds. It involves authorized private firms carrying out assessments of medical tests and moves away from a broadly self-certifying system (except for the lowest-risk products, such as laboratory equipment).

One of the main issues that could cause delays in access to new IVD medical devices, as well as existing products that require a conformity assessment is the severe lack of notified bodies designated to the IVDR.   EAPM is developing a paper on this topic which will be published in the coming months. 

AI regulation

Lawmakers in both the European Parliament and EU Council are moving ahead with drafting the bloc’s AI regulation, as MEPs in the leading internal market and civil liberties committees had to file their amendments on Wednesday (1 June) and national telecoms ministers will go over the text at their Friday (3 June) Telecoms Council meeting in Luxembourg. 

Regulating AI is a hot topic and lawmakers are very keen to redraft what’s already been drafted.

Cervical cancer screening

Women aged 24-49 who have a negative test for the human papillomavirus (HPV) could get screened for cervical cancer every five years rather than every three years, according to the British Medical Journal.

HPV infection is responsible for nearly all cervical cancers. The body will usually clear the virus but if that doesn’t happen, the cells in the cervix can become abnormal, which, if left untreated, can lead to cancer. Smear tests, also called pap tests or pap smears, are tests that look for those abnormal cells. 

Mask-free summer

While there is concern that summer festivals could be super-spreader events for monkeypox, that’s not really a fear expressed about COVID-19 anymore. With masks almost a thing of the past for much of Europe and thousands of holidays planned, it can feel like the world has moved on from the pandemic.

But despite the significantly better epidemiological situation, countries continue to assess and recommend additional vaccination doses.

Once again, registration is open for our  event on the EU Health Data Space for 7 June – click here to register and for the agenda, please click here.

And that is all from EAPM for this week - stay safe and well, and enjoy the weekend.

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