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EAPM: EU pushes pharma strategy, COVID health pass en route

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Welcome, health colleagues, to the first European Alliance for Personalised Medicine (EAPM) update of the week – among other issues, we have news on the EU’s pharma strategy, COVID-19 rapid antigen tests and progress on the COVID health pass, writes EAPM Executive Director Dr. Denis Horgan.

ITRE committee publishes draft opinion on pharma strategy

A draft report from the European Parliament health committee aims to ensure access to medicines, promote competitiveness and improve crisis-response mechanisms. Proposals from the Committee on the Environment, Public Health and Food Safety (ENVI) address how medicines are regulated in the European Union and, to a lesser extent, overseas. The report stresses the need to cut national approval times and align them with European Medicines Agency (EMA) workflows. ENVI also called on the European Commission to talk to member states about new pricing criteria such as whether a drug is ‘Made in Europe’.

Another set of proposals is intended to support “a competitive and innovative EU pharmaceutical industry.” ENVI calls on the Commission to “revise the use of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the EU”. ENVI also urged the Commission to develop appropriate regulatory frameworks for advanced therapy medicinal products and to work with EMA “to consider extending the application of rolling reviews to other emergency medicines”. The rolling review idea is based on the experience of authorizing COVID-19 vaccines. The report also addresses bolstering the resilience of supply chains. The committee wants the Commission to “facilitate agreements between the EMA and non-EU regulatory agencies on preventing emergencies and co-ordinating responses to them”.

Coronavirus: Health Security Committee updates common list of COVID-19 rapid antigen tests

The Health Security Committee (HSC) has agreed to update the common list of COVID-19 rapid antigen tests (RATs), including those whose results are mutually recognised by EU member states for public health measures. Following the update, 83 RATs are now included in the common list, of which the results of 35 tests are being mutually recognised.

Health and Food Safety Commissioner Stella Kyriakides said: “Rapid antigen tests play a crucial role to slow down the spread of COVID-19. Diagnostics are a central element for member states in their overall response to the pandemic. Having a wider list of recognised rapid antigen tests will also make it easier for citizens to benefit from Digital Green Certificates and to facilitate safe free movement inside the EU in the coming months.”

In addition, the Commission and the Joint Research Centre have agreed on a new procedure for updating the list of common and mutually recognised RATs in the future. From today onwards, RATs manufacturers will be able to submit data and information for certain tests that meet the criteria agreed by the Council on 21 January 2021. This includes only those rapid tests that are being carried out by a trained health professional or other trained operator and excludes rapid antigen self-tests. Moreover, as part of the new procedure, the HSC is setting up a technical working group of national experts to review the data submitted by countries and manufacturers and to propose updates to the HSC.

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EPP seeks separate health committee in Parliament

The European People’s Party is aiming to create a committee devoted to health issues in the European Parliament to deal with the pandemic’s impact, according to Andrzej Halicki, a senior member of the EPP. 

“The pandemic has changed our lives and it has raised the expectations of citizens,” the Polish MEP said. “We should be prepared as Parliament to talk, to decide how to implement the tools which are connected with our health security.” 

Beyond COVID-19, Halicki pointed to other looming health files, including the Pharmaceutical Strategy and medical devices. 

An EPP spokesperson confirmed that the group had rallied around Halicki’s proposal, and it will now be up to other political groups to support it, with a view to securing final adoption in the Parliament’s Conference of Presidents.

EU's COVID health pass to be operational in June

The EU is "fully on track" to ensure all its citizens and residents are able to have a free COVID health pass next month to ease travel, a spokesman said on Monday (10 May). The European Union is keen for anybody living in its 27 countries to be able to get a digital health pass - which the Commission refers to as a "green certificate" - to display their vaccination status, results of COVID-19 tests and whether they had recovered from a coronavirus infection.

"It will be ready for summer to facilitate safe travelling, so it will be ready to use... by the end of June," a European Commission spokesman, Christian Wigand, told a news conference.

Another spokesman, Johannes Bahrke, added that 18 EU countries plus non-member Iceland would test the digital document over the next two weeks to make sure any bugs were ironed out. It is seen as a key tool to save the European summer vacation period, allowing countries dependent on tourists to reopen to visitors less likely to bring Covid with them. Other countries around the world have moved in the same direction, including Israel with its "green pass", and Britain, which has told its citizens that some international travel will be permitted in a week with an app from its National Health Service (NHS) showing vaccinations received.

The EU's health pass will initially be used only for travel within the European bloc. But the European Commission is working on it being mutually recognised with certificates from non-EU countries, particularly the United States. There have been no discussions between Brussels and London so far on the EU system recognising Britain's NHS app. France, Malta and the Netherlands are among the countries piloting the EU's pass. The test involves making sure that digital keys used to authenticate the passes work correctly, and that it is interoperable across different countries' systems. The pass, while mostly designed to be accessed via smartphone app, also has to be able to be authenticated in paper form.

Health Commissioner Kyriakides proposes joint approach to develop COVID drugs

Last week, the European Commission proposed that EU nations join forces to develop and deploy COVID-19 drugs across the 27-nation bloc. In addition to the vaccine contracts already secured through a similar joint procurement, the EU's executive arm said it will set up a portfolio of 10 potential COVID-19 treatments, with the aim of authorizing three new ones to treat COVID-19 by October. So far, the antiviral medicine remdesivir is the only drug authorized across the EU for treating coronavirus patients. "Vaccinations save lives, but they cannot yet eradicate COVID-19. We need a strong push on treatments to limit the need for hospitalization, speed up recovery times and reduce mortality," said Stella Kyriakides, the bloc's health and food safety commissioner. The Commission said vaccines alone will not eradicate coronavirus overnight and efficient drugs and treatment plans will be required to treat patients in hospitals or at home, including those affected by long-term symptoms of the disease. Joint procurements can be launched with the agreement of member states, with a minimum of five EU countries required to start a procedure.

The Commission said it will invest €90 million ($108m) in studies and clinical trials and an extra €40m ($48m) to support manufacturing and access for COVID-19 drugs and treatments. In addition to the three drugs it plans to authorize in October, the executive branch said two more treatments could get approved by the end of the year. As part of its vaccine strategy, the Commission acted as an investor to provide funding to pharmaceutical companies developing vaccines, speed up production capacities and research. The European Commission has secured up to 2.6 billion doses of COVID-19 shots and is in negotiations with drugmakers for extra doses. But some EU nations have criticized the coordinated approach, blaming the EU for the initial slow rollout of COVID-19 vaccine shots across the region of 450 million people amid a contract dispute with AstraZeneca and production delays at other vaccine makers. Vaccinations have since sped up and a quarter of all EU residents have now received a first dose of coronavirus vaccine, according to Commission President Ursula von der Leyen. She says the bloc has secured enough doses to vaccinate 70% of all adults in the EU by the end of July.

Impact of the pandemic on cancer care

During an exchange of views with stakeholders, members of the Parliament’s Special Committee on Beating Cancer (BECA) identified the key messages emerging from the recent public consultation developed to draw lessons from the ongoing COVID-19 pandemic. The survey findings emphasize the need to build more resilient and equal health systems for disease and crisis preparedness across the EU. Additionally, the EU and its member states need to find ways to increase and improve cross-border collaboration for cancer prevention programmes and other cancer services.

This will help tackle health inequalities within and between member states, not only in cancer prevention, but also in screening, diagnosis and treatment. Another crucial point identified is the need to increase and strengthen specialised medical workforce. Finally, there is a need for a mechanism to help prevent shortages and mitigate disruptions of crucial medicines supply across the EU.

BECA Chairman Bartosz Arłukowicz (EPP, PL) said: “I very much welcome the pertinent recommendations from the BECA survey that will feed into our final report expected by the end of this year. The COVID-19 pandemic has created huge challenges for cancer patients to access care. However, cancer care can’t wait – for these patients, every day counts! It is our Committee’s mission, together with other politicians, the cancer community, public health organisations and medical experts, to do all we can to ensure that cancer patients receive the treatment they need at all times. In this context, I warmly welcome European-wide initiatives to tackle the challenges of the pandemic, such as the Time to Act campaign to be launched by the European Cancer Organization.”

BECA Rapporteur Véronique Trillet-Lenoir (Renew Europe, FR) said: “The COVID-19 pandemic constitutes a stress test for our health care systems with disproportionate negative effects on cancer care and patients. We need robust digital solutions and tele-medicine to be able to monitor cancer patients remotely and clear communication between patients, healthcare professionals and public authorities on emergency public health measures.”

And that is all from EAPM for now – stay safe, stay well, see you soon.

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