Good afternoon, health colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update. A report on EAPM’s recent autumn presidency conference in Brussels entitled ‘Redefining the Unmet Needs in Health Care and the Regulatory Challenge’ is available here, for anyone who missed it, and EAPM is now actively engaging with all the European institutions on all the pressing health-care issues, writes EAPM Executive Director Dr. Denis Horgan.
European Parliament’s pharma report voted through
The report on the pharmaceutical strategy authored by rapporteur Dolors Montserrat was voted through in a mid-day session of the Parliament on Wednesday (24 November) with 527 votes in favour and 92 against.
The own-initiative report has no binding authority, but it does present the Parliament’s position on the drug reform plan, and will help guide the Commission when it presents its concrete legislative proposal next year, a matter which the EAPM has strongly concerned itself with and is engaging with its members as well as the European Parliament.
Montserrat, who hails from the more business-friendly centre-right European People’s Party group, had to get the buy-in from the more Pharma-sceptical MEPs on the centre-left who favoured more of a focus on access and pricing issues.
She said: “It is a text that puts the patient at the center and strikes a balance between greater access to medicines, more predictable updated regulatory framework, the promotion of innovation and research to support a competitive European industry, and the sustainability of our national health systems.”
TRIPS waiver gets backing from Parliament
The amendment from the Greens in full support for a TRIPS waiver was also adopted on Wednesday with a handful of votes to spare. The amendment received 333 votes in favour, 328 against and 26 abstentions. Parliament’s political groups were split over the resolution ahead of the WTO’s ministerial conference, specifically on whether to waive patents for vaccines.
Parliament’s work on AI Act faces another delay
European Parliament lawmakers will not make a decision on which committee will lead negotiations on the AI Act before early December, according to two European Parliament officials.
In a meeting on Thursday (25 November), the Parliament’s Conference of Presidents, its highest decision-making group, decided to postpone the decision to 1 December.
The decision on which committee leads the bill has been postponed three times.
The Parliament has been embroiled in a bitter competency fight for months. The bill was initially allocated to the internal market committee, with social democrat MEP Brando Benifei (S&D, Italy) in the lead.
Germany ‘increasingly focused’ on the use of health data
The new German coalition that will govern Germany is outlining a proposed Health Data Usage Act it says will ensure the scientific use of health data in accordance with the General Data Protection Regulation (GDPR), the EU’s privacy rulebook. The new government also plans a check-up of current legislation on platform work to see if it needs a revision. In doing so, they will be able to lean on the EU’s initiative on the working conditions of platform work, tentatively scheduled for 8 December.
With regard to global health, the coalition supports reforms to (and strengthening of) the WHO. More imminently, the coalition wants to strengthen the COVAX project, including through the speedy delivery of vaccines to recipient countries.
The European Union has also launched into a new role taking ownership stakes in technology companies that receive injections of public funds in a move toward venture capitalism for Brussels.
The change will be presented in the EU capital by digital czar Margrethe Vestager and Innovation Commissioner Mariya Gabriel, and marks a break with the previous practice of issuing grants or supporting private investors.
EU needs companies that can scale, says Vestager
Europe is in need of more companies that can scale after the startup phase, the Commission’s Executive Vice President Margrethe Vestager said at the opening of the EIC Summit, the EU’s first-ever innovation gathering, on Wednesday. “Small can be very beautiful, but if you want to make the lead The number of startups per head of the population is the same in Europe and the US, Vestager said. But when it comes to scaling, the US has the advantage: four times as many scale-up companies as Europe. “Finding funding to scale is not an easy matter,” Vestager said, especially for companies working on advanced technologies, called “deep tech scale-ups.” The EU plans to step in.
Ethics rules for AI
193 countries are on the verge of adopting the world’s first recommendation on AI ethics.
The over 50-page-long recommendation has some red lines, such as a call to ban social scoring and the use of AI for mass surveillance. The recommendation also suggests that AI developers should conduct ethical impact assessments and that governments put in place “strong enforcement mechanisms and remedial actions, to make certain that human rights and fundamental freedoms and the rule of law are respected in the digital world and in the physical world.”
There are also some calls for specific themes like gender, education, culture and the environment. Countries should for example dedicate public funds to promote diversity in tech, protect indigenous communities and monitor the carbon footprint of AI technologies, such as large language models.
The recommendation is “the code to change the [AI sector’s] business model, more than anything,” Ramos said. “It is time for the governments to reassert their role to have good quality regulations, and incentivize the good use of AI and diminish the bad use,” she added.
The UNESCO recommendation also has a message for the EU, which is currently working on the world’s first AI bill. “Whenever you are not certain that the development of certain technologies is going to have a negative impact but you assume that they might — don’t do it. It’s as simple as that,” Ramos said. She expects the recommendation — which will be approved by all of the EU’s member countries — to influence negotiations in Brussels too. Many of UNESCO’s recommendations, such as having red lines and introducing redress mechanisms, are something that the European Parliament is already actively pushing.
It remains to be seen if the UNESCO recommendation will have much bite. The US, home to the world’s biggest AI companies, is not part of UNESCO and not a signatory. Meanwhile China, creator of the much-dreaded social scoring system, will this afternoon sign off on a recommendation that calls for the end of such a scoring system and of AI-powered mass surveillance. (I guess it helps that the recommendation is voluntary.)
The proof of the pudding will be in the eating, Ramos said, adding that the fact that Russia and China want to engage is a good sign. “At the end, we need to be [held] accountable. And sometimes it’s even difficult to look into accountability and responsibility in the digital world,” Ramos said.
Von der Leyen: Commission to propose Southern Africa travel shutdown over new coronavirus variant
Scientists in South Africa on Thursday (25 November) identified a concerning new coronavirus variant with mutations that one scientist said marked a “big jump in evolution,” prompting several countries to quickly limit travel from the region. Within hours, Britain, Israel and Singapore had restricted travel from South Africa and some neighboring countries, citing the threat of the new variant. By Friday, markets were down in Japan in response to the discovery, and officials in Australia and in New Zealand said that they were monitoring the new variant closely.
The European Commission will also propose restricting air travel to the bloc from southern Africa based on concerns over the variant, Ursula von der Leyen, the commission’s president, said in a Twitter post today (26 November). She referred to it by its scientific name, B.1.1.529.
And that is everything from EAPM for this week – don’t forget, you can check the recent conference here – stay safe, have an excellent weekend, see you next week.
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