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European Alliance for Personalised Medicine

EAPM as busy as ever on the health legislative and policy areas as year draws to a close




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Greetings at the start of Advent to the European Alliance for Personalised Medicine (EAPM) update. It was the first day of December yesterday (1 December), so the festive season is gathering pace, but EAPM is as busy as ever, and it was a busy November, with EAPM in the European Parliament hosting an event as well as a string of meetings at a national and EU level. 

The event in the European Parliament was focused on 'Navigating the Legislative Labyrinth for EU Healthcare that promotes the European Way' with several MEPs as well as the Commission in attendance and national regulators. As can be seen from the news below, there is a lot more navigating to be done, which EAPM will be following in its multistakeholder consensus driven way, writes EAPM Executive Director Denis Horgan. 

Pharma legislation review on its way

A revision of EU pharmaceutical legislation by the European Commission will be published on 21 December. These revisions indicate the execution of the European Commission's 2020 Pharmaceutical Strategy – a strategy that seeks to create a more resilient regulatory system in light of the COVID-19 pandemic. Health Commissioner Stella Kyriakides had a busy day on Wednesday (30 November). Among her commitments, she squeezed in an hour at ENVI and delivered several nuggets of information on the pharmaceutical legislation. Currently, the Commission is finalizing the impact assessment for the different options to be presented in the draft legislation for medicines. But it’s on track to still be delivered within the (delayed) Q1 schedule next year, she said.

Health Commissioner Stella Kyriakides delivered several nuggets of information on the pharmaceutical legislation on Wednesday (30 November). The Commission is finalizing the impact assessment for the different options to be presented in the draft legislation for medicines. Kyriakides said that the Commission is looking at the fact that the EU has among the most generous incentives in the world, with around 11 years’ monopoly at launch compared with six-to-eight years in other countries.

There will be no change in the stipulations for orphan drugs, which will still be designated for diseases with five people or fewer per 10,000. That’s one less item to discuss.There was a slight wrangle over the plans to make the Medical Devices Regulation more workable. German MEP Peter Liese said it was not reassuring that legal changes would not be proposed until next year, but Kyriakides responded that short-, mid- and long-term solutions are en route.

EAPM has published the following two papers on this topic which can be found at the following hyperlinks: Towards Better Pharmaceutical Provision in Europe—Who Decides the Future? and Meeting the Need for a Discussion of Unmet Medical Need.


Global health strategy 

The Commission has adopted a new EU Global Health Strategy to improve global health security and deliver better health for all in a changing world. With the Strategy, the EU deepens its leadership and reasserts its responsibility for tackling key global challenges and health inequalities head-on: the unfinished agenda in global health and combatting health threats in the age of pandemics. The Strategy positions global health as an essential pillar of EU external policy, a critical sector geopolitically and central to EU strategic autonomy. It promotes sustainable, meaningful partnerships of equals drawing on the Global Gateway. As the external dimension of the European Health Union, the strategy is designed to guide EU action for ensuring better preparedness and response to health threats in a seamless way.

Commission medical devices legal change claim

The European Commission has insisted that legal changes will come soon to resolve issues with the Medical Devices Regulation after evidence showed patients’ lives are being put at risk due to device shortages. Addressing a parliamentary committee, Health Commissioner Stella Kyriakides rebuffed concern that urgently needed legal changes will not come until next year. She was responding to a challenge from German MEP Peter Liese (EPP), who said he heard that there will be “no proposal this year and if a proposal next year, very limited”. Doctors and companies have been demanding for the law to be delayed or amended as there is limited capacity to issue 25,000 new certificates under the regulation, while the cost and clinical data requirements no longer make it a feasible market for some.

Health Commissioner: No planned changes to orphan prevalence criteria

The threshold for a medicine to qualify as a rare disease treatment will stay as it is in an upcoming legislative proposal, said Health Commissioner Stella Kyriakides. Currently, so-called orphan drugs benefit from a decade of market exclusivity, compared with eight years of data exclusivity for normal drugs. Medicines with the designation must treat diseases with a prevalence of five in 10,000 or less. The EU’s regulatory framework for orphan drugs is set out in Regulation (EC) No.141/2000 (the “Orphan Drug Regulation”, or ODR) and implementing Regulation (EC) No. 847/2000, and has been in force for a while now with relatively few changes. However, in recent years, a number of issues which challenge the current system have emerged, and the European Commission has attempted to address some of these by amending its (non-legally binding) guidance. The Commission’s health department is looking to modulate rare disease incentives, according to a draft impact assessment, with the present ten years of market exclusivity reserved only for medicines that meet a “high unmet medical need” and then only when it is then launched across all of the EU’s 27 national markets.

For a paper that EAPM has published on this topic, please see the following hyperlink: Making Sure That Orphan Incentives Tip the Right Way in Europe

EU research and development spend

Sweden is the most generous country in Europe when it comes to spending on research and development. The northern country spent 3.35 percent of its GDP on R&D in 2021, with Austria coming a close second, at 3.22 percent and Belgium third with 3.19 percent, according to a Eurostat report. But since 2019, Europe has sat in last place among the world’s biggest R&D spenders, when China overtook it. Europe was also the only region to see its percentage of R&D spending of GDP fall between 2020 and 2021, while the U.S., Japan and China all maintained constant rates.

Leadership at EU HTA top team

The EU’s Health Technology Assessment Coordination Group – the body that represents all participating HTA agencies in Europe’s new regulation — was meeting earlier this week and elected its first leader on Monday (28 November). But it didn’t quite get to the job of identifying members of the various committees, otherwise called subgroups. Roisin Adams, from the National Centre for Pharmacoeconomics, in Ireland, is the new chair. 

She will have two co-chairs to help guide the large group as it navigates the implementation of the HTA regulation: Niklas Hedberg, from Sweden’s Dental and Pharmaceuticals Benefits Agency, who has expertise in medicinal products. And Marco Marchetti, from Italy’s National Agency for Regional Healthcare Services, who has expertise in medical devices. 

The decision to elect two co-chairs, with medicines and devices expertise, will be reviewed and revised by the group six months before the regulation applies. The group also reached a consensus on its rules of procedure, deciding to operate in the interests of both medicines and devices until the regulation applies. But developers will likely have to wait until the next meeting in March to find out who is in each of the subgroups, including on joint scientific advice and clinical assessments. 

The coordination group said only that it “agreed to start the process of establishing” these groups. Once established, these will also cover both medicines and devices until the regulation applies.

Czech EU presidency fails to land Data Act deal

The Czech Republic is expected to only brief other EU countries on the progress of the bloc’s Data Act early December, failing to reach a deal on the file before the end of its presidency of the EU Council this year.

The Czech Presidency of the EU Council previously circulated a new compromise on the first five chapters of the new data law. The compromise was a real step toward the general approach the Czechs aim to reach by the end of their Presidency in December. Scope The text clarifies that the users of a connected device will enjoy access to the data they contributed to generating regardless of their place of establishment. Operators that use smart contracts within data spaces are also covered in the scope. 

The wording has been changed to clarify that the regulation does not preclude voluntary agreements on data exchange between private and public entities. It also does not affect the EU’s directive on unfair terms in consumer contracts. 

EU and US to unveil joint AI road map
The European Union and the United States are poised to announce a common effort for the development of beneficial artificial intelligence in the upcoming Trade and Technology Council in Washington, D.C. The road map aims to settle on shared definitions of key AI-related terms, and EU-U.S. collaboration in international organizations and standardization bodies to lay down rules advancing a pro-democracy framework for AI.

Commission signs off budgets for 2023 EU4Health programmes

The European Commission has adopted its 2023 EU4Health work program, outlining spending plans for close to €736 million to build up Europe’s health resiliency. The bulk of the funds — €358 million — will go toward crisis preparedness. That includes €243 million for the work of the Health Emergency preparedness and Response Authority (HERA) and €98 million toward improving and strengthening national surveillance systems to have clearer sight of the emerging health threats in Europe. This €118 million budget also includes the work to implement the Health Technology Assessment Regulation (€3 million); the pharmaceutical strategy and pharmaceuticals legislation (just over €8 million); the Medical Devices Regulation (just over €8 million); and the Blood, Tissues, Cells and Organs legislation (€1 million). And the big ambitions of the European Health Data Space file have a budget of €26 million next year.

And that is everything from EAPM for this week – do enjoy your first week of advent, stay safe and well, and see you next week.

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