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Good afternoon, and welcome to the European Alliance for Personalised Medicine (EAPM) update – we hope you are all enjoying a good start to the week. All our news items below will be tracked by EAPM at EU and country level, rašo EAPM vykdomasis direktorius dr. Denisas Horganas.

Pharma legislation delayed

It’s one of the hottest EU health policy files sitting on the European Commission’s desk: Reforming Europe’s 20-year-old pharmaceutical legislations. The intended date for delivering the draft legislation was December of this year, but this has now been delayed. The draft legislation will be delayed until “early 2023” a Commission official said. “The reform of the pharmaceutical legislation has been a top Commission priority in the area of health from the beginning of the mandate of this College,” the official said.

There are also big questions to be answered over how the legislation can drive innovation, ensure resilient medicines markets and supply chains, with widespread and fair access across the bloc.

Please see the following two hyperlinks to two academic articles that we published  relating to this file which sets out our position: Nepatenkintų medicininių poreikių aptarimas ir Geresnio farmacijos aprūpinimo Europoje link – kas sprendžia ateitį?

NGOs’ concern at EMA plan

The European Medicines Agency has allowed the deferral of up to five years for companies to upload their clinical trial protocols to Europe’s trials registry, but delaying the public’s access to this information on studies could be harmful, argue 15 NGOs who have co-signed an open letter to the agency’s chair, Lorraine Nolan.

reklama

Under the Clinical Trials Regulation, study sponsors must upload a summary of the Phase 2 and 3 trial outcomes within 12 months of completion, along with the study protocol. But in draft EMA proposals to deal with personal and confidential information, the EMA proposes allowing up to five years for the submission.

Retos ligos

Real-world data should be incorporated into assessments of therapies for rare diseases, according to a policy paper produced by consultancy firm Copenhagen Economics for the multidisciplinary European Expert Group of Orphan Drug Incentives. The group met last week and thrashed out a list of tweaks to improve the existing Orphan Medicinal Products Regulation, which is currently under review.

The group also recommended additional financial incentives, such as transferable vouchers or tax credits for drug developments in rare disease. The group also recommends a greater role for the EMA, in guiding developers and issuing guidelines on the use of off-label drugs and pharmacy preparations to treat rare diseases.

dirbtinis intelektas

The European Data Protection Supervisor has released an opinion on the convention on artificial intelligence (AI) and human rights under the aegis of the Council of Europe. On 18 August 2022, the European Commission issued a Recommendation for a Council Decision authorising the opening of negotiations on behalf of the European Union for a Council of Europe convention on artificial intelligence (AI), human rights, democracy and the rule of law (‘the convention’), pursuant to Article 218 TFEU.

 Having regard to the ‘trans-border’ nature of artificial intelligence, the EDPS welcomes the general objective, pursued by the Council of Europe, of elaborating the first legally binding international instrument on artificial intelligence, based on the Council of Europe’s standards on human rights, democracy and the rule of law. Accordingly, the EDPS supports the opening of negotiations on behalf of the Union for the convention, and welcomes the Union’s role in promoting trustworthy AI that is consistent with the Union’s values. The EDPS takes note of the fact that the subject matter of the convention would be regulated in the EU by the proposed AI Act, and acknowledges the Commission’s aim to ensure that the convention is compatible with the proposed AI Act, taking into account future developments in the legislative process. 

However, the EDPS considers that the convention represents an important opportunity to complement the proposed AI Act by strengthening the protection of fundamental rights of all persons affected by AI systems and therefore advocates that the convention provides clear and strong safeguards for the persons affected by the use of AI systems.

In the light of the above, the EDPS makes four main recommendations on the negotiating directives: the general objectives for the negotiation of the convention should give more prominence to the safeguards and rights to be provided to the individuals - and groups of individuals - subject to AI systems, in line with the primary focus and objectives of the Council of Europe; an explicit reference to compliance of the convention with the existing EU legal framework on data protection should be included in a specific directive; in line with the risk-based approach, the objective of imposing a prohibition on AI systems posing unacceptable risks should be introduced; the convention should promote the adoption of a data protection by design and by default approach at every step of AI systems’ life-cycle.

The Commission is seeking a mandate to negotiate on behalf of the EU, and the EDPS lays out its recommendations for what the EU should try to achieve. AI will have an impact on our societies that we hardly imagine. Algorithms are already said to be able to identify the best candidates for a job, assist doctors to establish medical diagnoses or help lawyers before the courts. All this is not entirely new, since already in the 1980s, expert systems assisted humans with a high level of expertise. What is new today is that computers are increasingly able to perform extremely complex tasks independently, but their designers sometimes no longer understand how, what has happened in the "black box" of deep learning.

As part of the Council of Europe's Elsinore reform process, the Secretary General will propose to the Committee of Ministers a strategic agenda and to include, by 2028, the issue of AI regulation as one of the major challenges in order to find a fair balance between the benefits of technological progress and the protection of our fundamental values.

Reynders ‘confident’ about new US privacy safeguards

Justice Commissioner Didier Reynders said he is confident that the White House’s move to limit US intelligence snooping as part of an EU-US data-sharing deal will survive legal scrutiny. 

Expecting a court challenge: “I’m quite sure that we will have a new legal challenge because there are so many activists, and I’ve seen the first reaction too,” the commissioner said in a phone interview. But, he added, “we have worked a lot to try to have a precise framework” and “we are sure that we have a very good result in the negotiations with U.S. colleagues.”

US President Joe Biden signed an executive order on 7 October, paving the way forward for a new transatlantic data agreement around March 2023, reported Vincent Manancourt and Mark Scott. 

Activist Max Schrems who has already succeeded twice in challenging transatlantic data flows over concerns about Washington’s snooping criticized the executive order after its release. “At first sight, it seems that the core issues were not solved and it will be back to the CJEU sooner or later,” he said.

COVID rates still on the rise

COVID rates continue to rise in Europe, but countries’ responses are notably different. In the UK, latest estimates from the Office for National Statistics suggest one in 37 people has coronavirus, a rise from one in 50 the week before. There are no isolation or mask rules in the country, and even testing with PCR in hospitals is reserved only for symptomatic cases. 

Numbers are also rising in Germany, inching toward 1,000 in every 100,000 people, while in Italy rates are around half this amount. The viral landscape is evolving, and Omicron BA.5’s domination may soon come to an end. Another Omicron variant, BQ.1.1, now makes up about 10 percent of infections in Belgium and is the most likely successor, said infectious diseases doctor Yves Van Laethem during a Friday (14 October) briefing by the national public health ministry. “There are good chances it will take over in the coming weeks,” he said. The variant’s rise may lead to a new spike in cases in a few weeks, Van Laethem said.  

“Although we are not where we were one year ago, it is clear that the COVID-19 pandemic is still not over,” said Health Commissioner Stella Kyriakides, World Health Organization Regional Director for Europe Hans Kluge, and Director of the European Centre for Disease Prevention and Control Andrea Ammon.

NHS waiting lists hit new unwanted record

More than 7 million people are now waiting for elective care in England’s National Health Service, according to analysis of data from August — setting a new record for the health system. But the worst waits of 18 months or more fell from a high of over 123,000 in September last year, to closer to 51,000 last month. Demand for emergency care also continues to be very high, with less than 57% of people seen within the four-hour target, compared with 76% for the same month before the pandemic, in 2019. While the most urgent ambulance calls, known as category 1, saw rates one-fifth higher in September than before the pandemic.

Despite the surging demand for services, the NHS also checked over 255,000 people for cancer following an urgent referral in August, the highest number since records began. 

The sector needs more cash (something that Liz Truss’ government has put into question by ending the National Insurance tax rise to buoy the service), he said. At a minimum, it needs £2 billion extra a year for the next three years, amounting to a £6bn increase.

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