Bastille Day beckons to future in health legislative and policy files 

Good afternoon, health colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update on French Bastille Day (14 July). Today, the update shines a light on the movers and shakers in terms of legislative and policy files at the EU level, during a very busy period for EAPM, as EAPM pushes. forward to ensure that lung cancer screening is included in the update of the EU Council Recommendation of Screening from 2003. EAPM is making the rounds to different member states at the moment, so as to ensure that political will translates into action for implementation so that patients and citizens get diagnosed earlier, writes EAPM Executive Director Dr. Denis Horgan.

European Medicines Agency trials raw data assessments 

The European Medicines Agency (EMA) is launching a new pilot to trial drug assessments for new medicines and to expand the use of existing therapies, by assessing this so-called raw data.

The EMA is asking companies to participate in the pilot to submit raw, unformatted data in its applications. That would include anonymized individual patient data from clinical studies in electronic format that is directly accessible for analysis and visualization. It could be records of original observations of clinical study participants, such as clinical laboratory results, imaging data, and patient medical charts.

This will provide a potentially quicker assessment, the EMA says, and a better definition of the target treatment population.

Cross-border health threats 

Members of the European Parliament’s ENVI committee formally approved the cross-border threats to health regulation on Tuesday (12 July), with 72 votes in favor, two against and two abstentions. The regulation is expected to be put to a broader vote this fall, during the first plenary session in October.

Artificial intelligence

A vote in the legal affairs committee on the Artificial Intelligence Act scheduled for today (14 July) was killed after a disagreement emerged between the centre-right EPP and the Greens. After hammering out a cross-party compromise, the Greens proposed voting on extra amendments. According to the office of lead lawmaker Axel Voss, of the EPP, a new meeting on 29 August will aim to solve the issue for an early September vote.

Path to the Digital Decade 

The Commission welcomes the political agreement reached by the European Parliament and the Council of the EU on the 2030 Policy Programme: Path to the Digital Decade. The programme sets up a monitoring and cooperation mechanism to achieve the common objectives and targets for Europe's digital transformation set out in the 2030 Digital Compass. This concerns the area of skills and infrastructure, including connectivity, the digitalisation of businesses and online public services as well as the respect of the EU's Digital rights and principles in achieving the general objectives.

A Europe Fit for the Digital Age Executive Vice President Margrethe Vestager said: “The Digital Decade is about making digital technology work for people and businesses. It is about enabling everyone to have the skills to participate in the digital society. To be empowered. It is about empowering businesses. It is about the infrastructure that keeps us connected. It is about bringing government services closer to citizens. Europe's digital transformation will give opportunities for everyone.”

Blood, tissues and cells

The European Commission’s proposed overhaul of the rules overseeing blood, tissues and cells (BTC) is expected to land today (14 July). This consultation concerns an initiative for an improved EU legal framework for the safety and quality of blood, tissues and cells used in transfusion, transplantation and medically assisted reproduction. These are healthcare services that impact on the lives of millions of EU citizens, both as donors of essential substances or patients that need treatment with those substances. For this reason, this public consultation is collecting the views of all interested citizens and organisations.

The EU legislation on blood, tissues and cells (BTC legislation, adopted in 2002 and 2004) ensures safety and quality of these substances used every day to treat patients, in transfusion, cell and tissue transplantation or medically assisted reproduction. The donations are also critical for the manufacture of certain medicines. The BTC legislation was evaluated by the Commission and the results were published in October 2019. The evaluation concluded that the legislation had effectively improved the safety and quality of these substances in the EU but it identified a number of shortcomings and gaps. 

Top health experts assemble before MEPs 

At the Parliament’s special committee on COVID-19, the heads of the European Centre for Disease Prevention and Control (ECDC) and the Health Emergency Preparedness and Response Authority (HERA) are up before MEPs, as well as the chief epidemiologists from five EU countries. 

EPP MEP Tomislav Sokol said that he will want to know how prepared the EU is to respond to future health threats. “With more adaptable, flexible, and faster decision-making in future health crises, we will not lose two or three months on export restrictions, closures of borders, organizing coordination, etc,” said Sokol. “We need to make sure that the system of common response, c-ordination and cooperation is ready for the future when it comes to ECDC and HERA.” 

Green MEP Tilly Metz said that she is looking forward to hearing from the epidemiologists how the work of scientists was taken into account or, indeed, ignored by governments. Metz also expects an update on the new variants and adapted vaccines as well as how governments can move from a pandemic to an endemic state. “I would also like to hear the opinion of HERA with regards to possible investments that need to be made [so as] to not rely as much as we used to on the pharmaceutical industry, and have their thoughts on possible needs to change the regulatory framework to that end,” she said.  

Identifying the threats is the start of the process to ensure that medical countermeasures are developed, produced and procured.

Draft ‘pandemic treaty’ shows big ambitions, long road to agreement

The intergovernmental negotiating body, tasked with drafting and negotiating this international instrument, will hold its next meeting by 1 August 2022, to discuss progress on a working draft. It will then deliver a progress report to the 76th World Health Assembly in 2023, with the aim to adopt the instrument by 2024. 

The COVID-19 pandemic is a global challenge. No single government or institution can address the threat of future pandemics alone. A convention, agreement or other international instrument is legally binding under international law. An agreement on pandemic prevention, preparedness and response adopted under the World Health Organization (WHO) would enable countries around the globe to strengthen national, regional and global capacities and resilience to future pandemics.

US to share technology to make COVID-19 vaccines through the World Health Organization

The United States will share technologies used to make COVID-19 vaccines through the World Health Organization and is working to expand rapid testing and antiviral treatments for hard-to-reach populations, US President Joe Biden has said. Biden called on Congress to provide additional funds so that the U.S. may contribute more to the global pandemic response. 

"We are making available health technologies that are owned by the United States government, including stabilized spike protein that is used in many COVID-19 vaccines," Biden said. The work is set to build on efforts and commitments made at the first global summit in September, including getting more people vaccinated, sending tests and treatments to highest-risk populations, expanding protections to health-care workers, and generating financing for pandemic preparedness.

And that is everything from EAPM for now. Stay safe and well, and enjoy your weekend.

Share this article: