Unprecedented work schedule ahead of 2024 election

The resumption of the political process does not only concern the national territory, but also brings problems that must be resolved as the Spanish scene burns. Not in vain, Europe is expected to have a tense agenda, In terms of health policy, it is even unprecedented. It is at this level that Spain, which begins its presidency of the Council of the European Union in July, will play a central role.While the legislative component for continental governance is minimal – elections are due in 2024 – several initiatives are underway to Medicine package as the main job.

The first draft of the review, published in parliament in April, proposes a framework that will set the rules of the game to improve opportunities for innovation, streamline regulatory processes and address supply shortages. All in all, the most feasible scenario is that its final green light will be delayed until after the community election date, as the S&D MEP has advanced to EG, Nicholas Gonzalez Casares.

Still, discussions are likely to revolve around issues such as a new incentive system that “rewards companies that go the extra mile,” in the words of the European health commissioner, Stella Kyriakides, and a coupon program for new antibiotics.The medicines package therefore includes legislation for medicines, orphan medicines and pediatric medicines, and Council recommends stepping up efforts to combat antimicrobial resistance (AMR). In fact, the operation made the most progress, being approved by Parliament and Council on 13 June.

European pharmaceutical employers (European Food Industry Association, its English abbreviation) is not entirely convinced of the benefits of the above proposal. Although they see it as an opportunity for the EU to “accelerate patient access to safe, effective and affordable medicines and improve supply security”, the text would have the opposite effect. “The impact of these proposals will harm innovation and further weaken Europe’s competitiveness.”they have been aiming.

EHDS: Great Hope

The advancement of another major reform, such as European Health Data Space (EHDS). Its main benefit seems to convince everyone: it will improve interoperability and cross-border access to patients’ medical records, potentially broadening the basis on which they make treatment and diagnostic decisions. However, the secondary use of such data is a major topic of debate over the realization of one of the key pillars of the European Health Union, whose original proposal completed its first year of work in May and has as many as 2,100 amendments pending review .

The first goal set for this continental “data lake” is for patients to be able to share their health data, medical history and prescriptions with all hospitals and doctors in an EU environment. Regarding the secondary use of these data, they discuss how to provide access to said data to researchers, politicians, innovators or re-users. In this sense, our task is to define the legal framework through which they will be able to access this information in order to optimize their operations, but anonymously in a secure environment that respects the information. General Data Protection Regulation.

The main topic of debate during discussions on the European health data space is related to its secondary use

The dossier’s rapporteur, Tomislav Sokol (PPE), said he hoped parliament would be able to complete work on the dossier and start inter-agency negotiations by September. According to the Croatian Ministry of Environmental Protection, financing and implementation timelines will be the two main issues of dialogue between the agencies.Speech by Spain, the presidency of the European Council A common position is expected to be reached by the end of the year; thus, the most optimistic deadline would guarantee that the EHDS would finally materialize in June 2024 and be operational in the following academic year.

SoHO, EMA rates and key drugs

The time is getting closer and there are signs of a positive end Review of Safety and Quality Standards for Substances of Human Origin (SoHO). The intended objective is to achieve this within the framework of the Spanish Continental Mandate, so its final wording will be agreed by the end of the year, based on the proposals presented by the Commission in 2022. The plans of the Spanish presidency reflect the importance of monitoring the functioning of centers involved in the access to different substances and their use”.

As far as he is concerned, EMA’s new interest rate regulation to be finalized in December. Firm steps have been taken and positive feedback has been received. It was validated by EPSCO back in June, and EFPIA itself gave a positive opinion; the purpose of this update is to simplify the rates, achieve a more agile and flexible system, and guarantee the sustainability of the system. In the future, the Spanish presidency of the Council has the right to start negotiations with the European Parliament with a view to reaching an interim agreement.

On the other hand, the committee is expected to propose a list of critical medicines, including those deemed essential to health systems at EU level, as a response to shortages.Kyriakides announced that the list will be announced at the end of the year, which will help “Monitoring the supply of essential medicines and addressing supply chain vulnerabilities”.

The committee also supports the pandemic treaty currently being negotiated. In fact, it will participate in meetings of the World Health Organization’s Intergovernmental Negotiating Body (INB). A preliminary version was presented in March, but work is scheduled to culminate in 2024 and be submitted to the 77th World Health Assembly for adoption.

Advances in the European Anti-Cancer Program

European Commission announces in 2023 work program update 2009 Council recommendations on smoke-free environments. The proposal, due to be published by the end of the year, is part of a European plan to fight cancer. In this way, it will seek to achieve its goal of protecting people across the EU from second-hand tobacco smoke by extending its coverage to emerging products and expanding smoke-free environments, including outdoor spaces such as schools and playgrounds.

Also included in the 2023 plan EU Council recommendations on vaccine-preventable cancersIt is expected to take place in the third quarter of 2023. The ultimate goal is to help EU countries address the cancer risks associated with hepatitis B (HBV) and human papillomavirus (HPV) infections. The European Anti-Cancer Plan has set goals to vaccinate at least 90% of girls against HPV by the age of 15 and to increase vaccinations among boys by 2030. Currently, the vaccination program is already underway, and the roadmap will be updated in 2020. the next few months.

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