November 30, 2023

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Good morning, health colleagues, welcome to the European Alliance for Personalised Medicine (EAPM) update, and a very happy St. Patrick’s Day! EAPM enjoyed a hugely successful series of consensus panels yesterday (15 March) on pharma legislation, and a more detailed update will follow, while EAPM will be working on a series of expert panels on the EU Beating Cancer Plan relating to tackling thyroid cancer, leukemia and lung cancer in the weeks ahead, and EAPM is also busy planning for its April Presidency Conference, writes EAPM Executive Director Dr. Denis Horgan. 

April Presidency Conference on April 5th: Determining a path for optimal integration of  Access & Diagnostics for All & Public Health Genomics

Here are the sessions for the conference – registration will open next week. 

  • Opening Session: Public Health and Genomics: the future is already here 
  • Plenary Session I: Bringing innovation into Healthcare Systems Plenary
  • PlenarySession II: Molecular Diagnostics, Screening and Early Diagnosis to the Fore 
  • Plenary Session III: Diagnosis and Treating Patients 
  • Plenary Session IV: Regulating the Future: Impact of the In-vitro Diagnostic Regulation
  • Closing Session 

Regulating the future – Balancing patient safety and facilitating innovation with IVDR: Quick Snapshot from Expert Panel

There are many stakes in the tension between improving patient safety – through the stricter rules of the IVDR – and imperilling health care performance, because of the shortages or total lacks that will occur in many important diagnostic tests. IVDR could ensure uniform safety and performance levels across Europe and harmonize requirements. But it carries a risk of over-regulation and leads to what has been described as the end of the laboratory-developed tests as we know them. 

It mainly addresses commercially available IVD kits, and it introduces general obligations that manufacturers have to fulfill with regards to quality management systems, risk management systems, technical documentation and post-market surveillance. The expertise of medical lab specialists and reference labs has to be taken into account, and “sprawling interpretation” must be avoided because this would be ultimately detrimental to patients.   

The consensus paper that will be an outcome of this expert panel will be published in April. 

European Health Data Space: From vision to implementation and impact

The European Commission is set to revolutionise the way data is shared across borders with plans moving at pace to implement a European Health Data Space (EHDS). Part of the overall European strategy for data, the EHDS will include both primary and secondary use of health data, enabling citizens, researchers and decision-makers seamless access to this information, regardless of where it is stored. 

Member states welcomed proposals for the EHDS in the European Council Conclusions in 2020 and its implementation will be a priority under the French Presidency of the EU in 2022. One key milestone in the journey towards the EHDS will be the proposal of a new act around data sharing, due out in March. This session will discuss the expectations, the potential impact, and the stakeholder collaborations that will be needed to advance the setting up of the EHDS. It will share high-level strategic and political perspectives and highlight the future implementation phase of the initiative.

Compromise reached on COVID-19 vaccine intellectual property rights waiver

The United States, European Union, India and South Africa have reached a consensus on key elements of a long-sought intellectual property waiver for COVID-19 vaccines, according to a proposed text reviewed by Reuters.

Sources familiar with the talks described the text as a tentative agreement among the four World Trade Organization members that still needs formal approvals from the parties before it can be considered official. Any agreement must be accepted by the WTO’s 164 member countries in order to be adopted.

Some elements of the consensus deal, including whether the length of any patent waivers would be three years or five years, still need to be finalized, according to the text. It would apply only to patents for COVID-19 vaccines, which would be much more limited in scope than a broad proposed WTO waiver that had won backing from the United States, according to the document.

Médecins Sans Frontières/Doctors Without Borders (MSF) acknowledges the efforts towards a final resolution, but notes that the text leaked is far from being an IP “waiver” for pandemic medical tools. MSF urges all World Trade Organization (WTO) members to be aware of the limitations of the leaked text. WTO members should work together to ensure that any agreement tackles the current barriers to accessing all COVID-19 medical tools, including treatments and diagnostics, and also addresses patents and non-patent barriers in an effective way. 

According to MSF’s initial analysis, key limitations of the leaked text include that it covers only vaccines, is geographically limited, and covers only patents and does not address other intellectual property barriers, such as trade secrets, which may cover critical information needed to facilitate manufacturing. Regarding compulsory licensing for patents on COVID-19 vaccines, the leaked text introduces unnecessary reporting requirements for WTO members that could undermine the effectiveness of the mechanism. 

The leaked text appears to leave the door open for possible inclusion of treatments and diagnostics at a later stage. But delaying the decision on treatments is unacceptable, as many people will have no access to generic antivirals and countries are paying high prices for access to lifesaving treatments like baricitinib due to patent monopolies that block more affordable generic versions. 

An international treaty on pandemic prevention and preparedness 

On 3 March 2022, the Council adopted a decision to authorise the opening of negotiations for an international agreement on pandemic prevention, preparedness and response. 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. 

Global health diplomats have met and will convene again to try to hash out how exactly to develop a pandemic treaty. The meeting of the intergovernmental negotiating body aims to agree on the “working methods and timelines” for the treaty (or whatever it is eventually called) as well as how they will go about identifying what it will actually contain. The aim is for a working draft to be presented for consideration at the second meeting of the negotiating body. 

EU health-care systems adjusting to arrival of 2.5 million Ukrainian refugees 

The EU’s health-care systems, already stretched from the COVID-19 pandemic, are adjusting to deal with the huge influx of new arrivals from Ukraine – numbered over 2.5 million, as of Friday (11 March). Poland has already received over 1.5 million people based on UNHCR data, making it the member state that has taken in the largest number of new arrivals. The Polish health ministry’s spokesperson said that the country has prepared around 7,000 places for Ukrainian citizens, across approximately 120 hospitals. 

The total number of patients in Poland was not specified, but the ministry said that over 700 children have been treated in the country’s hospitals as of Friday. “Their most common diseases are pneumonia as a result of travelling from Ukraine. There are a few children who need dialysis and there are children with cancer,” the spokesperson said. Sandra Gallina, the director-general of DG SANTE, the Commission’s health policy-making body, said that fleeing people do not only “have to spend time in the cold” but also are coming with cancer conditions, heart conditions or psychiatric illnesses. “You get a perfect recipe for unhealthy states at the end of the day,” she said, adding that “we need to extend to them a helping hand”. And countries bordering Ukraine cannot manage this alone. 

As the refugee flow continues, the Polish Health ministry is co-operating with the European Commission and the French Presidency of the EU in discussions on relocation of patients coming from Ukraine. “Currently a mechanism of relocating Ukrainian patients from Poland to other countries is being worked out. 

The Commission reported that over 10,000 beds are available in the EU member states,” Polish health ministry’s spokesperson said. Isabel de la Mata, the principal advisor at DG SANTE, explained on the webinar that the coordination mechanism for the transfer of patients is provided through the Directorate-General for European Civil Protection and Humanitarian Aid Operations (DG ECHO) and the Emergency Response Coordination Centre (ERCC). Both organizations work closely with the national competent authorities, she explained. Medicines and medical devices are also included in the transfers via the EU civil protection mechanism, and the requests received so far can be shared with any interested stakeholders.

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