Focus on IVDR for EAPM by engaging with stakeholders

Good afternoon, health colleagues, and welcome to the first European Alliance for Personalised Medicine (EAPM) update of the week. As the year moves towards its end, EAPM will be focusing on the implementation of In Vitro Diagnostic Regulation (IVDR) by engaging with our stakeholders in organizing expert meetings with them...a more detailed update will come presently, but more information below, writes EAPM Executive Director Denis Horgan. 

IVDR

As diligent readers of our update will know, a new EU regulation on In Vitro Diagnostics will come into effect in 2022 and will have a major impact on the evaluation and approval process of IVDs.

In this context, EAPM has organized a series of expert panels on which a report will be forthcoming.

Without some sustainable amendment to IVDR, there is a risk that any niche – and not so niche – IVD medical tests will disappear. Participants in the expert round table reported that some tests simply will not be available if the regime is enforced on the timings envisaged. "There will be real problems ahead." The participant added: "We don't know what tests we will have available next year." Already, availability is uneven across Europe. And now it is apparent that awareness of the impending difficulties also varies widely from country to country, with a high perception of the risks in The Netherlands but still only limited sense of urgency in Hungary.

In addition, companies that decide to seek national derogations for their products in order to maintain them on the market would be obliged to generate a tidal wave of paperwork that could overwhelm their own resources and create a logjam in national regulatory agencies, since there will be upwards of 20,000 products that will need certification for the first time.

Health committee votes through pharma strategy report

MEPs on the European Parliament’s committee on the Environment, Public Health and Food Safety today voted through a report on the Commissions pharmaceutical strategy.  The own-initiative report was passed with 62 votes in favor, 8 against and 8 abstentions. Authored by rapporteur Dolors Montserrat, Spanish MEP from the center-right European People’s Party, the non-binding text represents the Parliament’s input into the Commission pharmaceutical strategy.  

A draft of the report was first published in May and it called on the Commission to redefine incentives for drug development to take into account unmet patient needs. It also asks the Commission to improve price transparency, while still ensuring that the industry remains competitive.  On Monday MEPs passed so-called compromise amendments to the report — which are the result of negotiations between the different political parties in the Parliament. The amendments put a greater emphasis on conditions on public investment into research, antimicrobial resistance and resilient pharmaceutical supply chains. Other proposals include giving the European Medicines Agency greater oversight over drug and device combinations, as well as the creation of an action plan for advanced therapy medicinal products (ATMPS). Next, MEPs will vote whether to approve the report in a plenary session in November. Then, in late 2022, the Commission will publish its proposal to overhaul the EU’s pharmaceutical rules.

Health council

Europe’s health ministers meet today (12 October) in Slovenia — and virtually — for the Health Council, a day that will see EU health resilience at front and centre of discussions. Joined by Health Commissioner Stella Kyriakides, the ministers will discuss the hot button topic of resilient medicines supplies.

Health ministers will also discuss improving the response and preparedness to cross-border health threats; how to strengthen health systems under the EU Health Union banner; and of course, COVID-19 vaccination across the bloc.

ENVI ready to reinforce EU disease prevention

MEPs are ready to negotiate with member states to reinforce the EU’s disease prevention and control framework and jointly tackle cross-border health threats,* according to the ENVI plenary session. The proposal to extend the mandate of the European Centre for Disease Prevention and Control (ECDC) was adopted with 598 votes in favour, 84 against and 13 abstentions. EU member states should develop national preparedness and response plans, and provide timely, comparable and high quality data, MEPs say. They also want to ensure that the ECDC’s mandate is extended beyond communicable diseases to also cover major non-communicable diseases, like cardiovascular and respiratory diseases, cancer, diabetes or mental illness. The legislative proposal to strengthen the EU’s crisis prevention, preparedness and response when addressing future serious cross-border health threats was adopted with 594 votes in favour, 85 against and 16 abstentions. The COVID-19 crisis revealed that further work at EU level is needed to support cooperation between member states, in particular border regions, MEPs stress. The text also calls for clear procedures and more transparency for EU joint procurement activities and related purchase agreements.

Europe can’t agree on how to regulate tech giants

The question of how to regulate tech giants has been high on the agenda for most countries around the world, but a new report today says that Europe is struggling to answer it. The European Union has been working on its plans for several years, and appeared to have reached some kind of consensus last year – which would include limiting Apple’s powers in regard to the App Store, and could also place limits on its ability to acquire companies.  

However, the Financial Times reports that the outline agreement now appears to be unraveling, with arguments between right and left over the extent of the antitrust measures needed: Last year, the EU unveiled a radical blueprint for tech regulation that would put onerous responsibilities on the likes of Google, Facebook, and Amazon to clean up their platforms and ensure fair competition. But since then, the package of measures has become bogged down in the European parliament, and now risks being watered down and heavily delayed. There are even fears in Brussels that the new rules will not be in place before Margrethe Vestager, the EU’s competition and digital policy chief, leaves her post in three years. “It sounded like we had agreed but that is not the case . . . at all. We are a long way from having a common position on this,” Evelyne Gebhardt, a German MEP, said in exasperation during the debate

Medicines and vaccines regulators under scrutiny

Never before have the regulators of medicines — and vaccines — been under such pressure and scrutiny. Among those in the spotlight have been the European Medicines Agency’s vaccines lead Marco Cavaleri and Fergus Sweeney, head of trials and manufacturing at the agency.

It’s tough going, being in Europe’s network of regulators. The pandemic “is placing a sustained and intense demand on the EMRN’s resources,” the article states. With faster decisions, constant monitoring, clear and frequent communication, on top of regular work, “the resilience of EU medicines regulators has never been tested to this extent.”

An EU EUA? The U.S. has issued emergency use authorizations (EUAs) to vaccines and treatments during the pandemic to quicken access to promising solutions. Whereas the EMA has used rolling reviews to quicken assessments, and conditional marketing authorizations. But the agency is open to change. “EUA could in some circumstances provide an additional regulatory tool at EU level, giving more flexibility to EMA to respond to emerging threats and protect public health.”

Life science chiefs present G20 with health policy to-do list

On Friday (15 October), some of the world’s top leaders in the life sciences sector are presenting recommendations to Italian Prime Minister Mario Draghi, the chair of the G20, on how health systems should foster and adopt innovation.

Seizing on a moment when both governments and citizens are highly alert to the life-saving benefits of science and investing in innovation, the sector is setting out both what it needs to thrive and how health systems should adapt to reap the benefits.

“Health is wealth,” Sergio Dompé, president of the 130-year-old family business Dompé Pharmaceuticals and coordinator of the B20 Health & Life Sciences Task Force, told POLITICO. Countries need to view “health as an investment, not as an expense.”

For economies squeezed by the pandemic and facing huge health care backlogs, he said, wearable technologies could help detect and intervene early, preventing bigger problems. The report also recommends building more resilient supply chains through G20 partnerships and supports global collaboration on crisis preparedness. Countries should drive for environmentally sustainable health system solutions, it states.

HERA

After taking heavy fire last week at ENVI over the European Parliament’s exclusion from discussions on the formation and role of HERA — the EU’s new Health Emergency preparedness and Response Authority — Health Commissioner Stella Kyriakides said that it was clear from the pandemic that people wanted the EU to do more. While the EU is now the most vaccinated continent on the planet and its vaccine roll out has been largely successful, Kyriakides said that the actions at the time were ad hoc and the pandemic had shown that a more structured approach is needed. 

Good news to finish as a 100-year-old puzzle is solved

The 100-year quest to create a malaria vaccine has succeeded. In a historic day for medicine (6 October), the World Health Organization recommended the widespread roll-out of the new jab in sub-Saharan Africa. Pioneered in Brentford, west London, the vaccine is safe, cost-effective and cuts the chance of young people dying from what was, until 2020, the world’s most deadly infectious disease. The developers, GlaxoSmithKline, should be applauded for their commitment to provide 15 million doses a year at no more than 5 per cent above production cost. Scientists hope that this news will reignite the race to develop other malaria vaccines with even greater potential to stop the parasite.

And that is all for now from EAPM – stay safe, stay well, have an excellent week.

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