EAPM: The necessity for change – EU to the fore on most cancers, information governance and HTA

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Good morning and welcome, health colleagues, to the second update of the week of the European Alliance for Personalized Medicine (EAPM) – it looks like more than 150 people have now registered for our upcoming EAPM conference of the Slovenian EU Council Presidency on July 1st time to join them and book your place before it’s too late and we also have an update on the European Parliament’s draft report on strengthening Europe in the fight against cancer, writes EAPM Executive Director Dr. Denis Horgan.

The EAPM conference is getting closer – once again as a reminder

The EAPM conference will act as a bridging event between the EU presidencies of the Portugal and Slovenia. The conference is divided into sessions covering the following areas: Session 1: Generation of alignment in the regulation of Personalized Medicine: RWE and Citizen Trus; Session 2: Beating Prostate Cancer and Lung Cancer – The Role of EU Beating Cancer: Updating EU Council Conclusions on Molecular Diagnostic Screening.

Each session will include panel discussions as well as Q&A sessions to ensure the best possible engagement for all attendees, so now is the time to sign up Here, and download your agenda Here.

Fight against cancer – Parliament’s main draft report

As mentioned in previous updates, the European Parliament set up a special committee to fight cancer. On the last day, she published her first draft report on the EU Beating Cancer Plan, which contains a number of points that the EAPM has been campaigning for over the past few months and highlights the key issues that make its membership multi-stakeholder represent.

Divided into numerous articles, Article 66 The report is of particular attention to EAPM members as tremendous advances in biology have shown that cancer is an umbrella term for more than 200 diseases and that precision or personalized medicine can be made available through targeted agents in a variety of ways .

The report also considers precision or personalized medicine, consisting of treatment choices based on individual tumor biomarkers, to be a promising way to improve cancer treatment and encourages member states to promote the implementation of regional molecular genetics platforms and equal and rapid access to them individual treatment for patients.

In addition, Article 48 In the draft report, calls on the Commission to promote the role of general practitioners, paediatricians and healthcare professionals, given their importance in referring patients to diagnostic tests and oncology specialists, and during cancer treatment and aftercare, and to strengthen Member States -up care; calls for the development of multidisciplinary decision-making in the context of special consultation sessions bringing together different cancer specialists.

According to Article 61, the provisional agreement reached by the European Parliament and the Council on 22 June 2021 on the Health Technology Assessment Regulation (HTA) to harmonize access to innovative cancer diagnoses and treatments is welcomed.

Perhaps most importantly Article 87 sees the urgent need for a European Charter on the Rights of Cancer Patients; calls for this charter to define the rights of cancer patients at every stage of their treatment pathway, ie access to prevention, initial diagnosis and throughout treatment, and to apply equally to all EU citizens, regardless of which country or region they are in Life.

In addition, Article 105 Looks at the flagship “Cancer Diagnosis and Treatment for All” and highlights the need to use “Next Generation Sequencing” technology for fast and efficient genetic profiles of tumor cells that allow researchers and clinicians to exchange and apply the same or similar cancer profiles diagnostic and therapeutic approaches in patients with a comparable cancer profile.

The EAPM looks forward to further advances in the fight against cancer with enthusiasm. In this context, the EAPM is working with its experts on NGS and RWE on two publications that will provide additional input / guidance to the European politicians with whom the EAPM works.

Political agreement on HTA

The Commission welcomes the political agreement reached by the European Parliament and the Council on 23 June on the Health Technology Assessment Regulation (HTA). The regulation will improve the availability of innovative health technologies such as innovative medicines and certain medical devices to EU patients, ensure efficient use of resources and improve the quality of HTAs across the EU. Examples of health technologies are pharmaceuticals, medical devices, and diagnostics. It will also facilitate business predictability, reduce duplication for HTA bodies and industry, and ensure the long-term sustainability of EU HTA cooperation.

EU Health and Food Safety Commissioner Stella Kyriakides welcomed the agreement and made the following statement: “I am very pleased that the European Parliament and the Council have reached a long-awaited political agreement on the regulation on health technology assessment. The regulation will be a significant step forward to enable joint scientific evaluations of promising treatments and medical devices at EU level. “

Advances in vaccination are welcomed, but further efforts are strongly recommended

The European Council welcomed the good progress on vaccination and the general improvement in the epidemiological situation, but stressed the need to continue vaccination efforts and to be vigilant and coordinated with developments, in particular the occurrence and spread of variants.

According to the draft European Council conclusions for the 24-25 June meeting, the Council stated that it “reaffirmed the EU’s commitment to international solidarity in response to the pandemic”.

“All producing countries and manufacturers should actively contribute to efforts to increase the global supply of COVID-19 vaccines, raw materials, treatments and therapeutics and to coordinate measures in the event of bottlenecks in supply and distribution,” says the draft text.

The conclusions also refer to recent travel agreements within the EU which state that Member States apply these measures “in a way that ensures a full return to free movement as soon as the public health situation allows”. The Council also intends to welcome the decision to set up a special session for the World Health Assembly to discuss a pandemic treaty, with the EU saying it will continue to work towards a treaty goal.

WHO, WIPO and WTO agree on increased cooperation to combat the COVID-19 pandemic

On June 15, WHO, WIPO and WTO Directors-General met in a spirit of cooperation and solidarity to develop further collaboration in addressing the COVID-19 pandemic and pressing global challenges at the interface between public health and intellectual property and trade. Aware of their shared responsibility to communities around the world facing a health crisis of unprecedented severity and scale, the organizations have committed to using all of the expertise and resources of their respective institutions to end the COVID-19 pandemic deploy and improve the health and wellbeing of all people around the world.

The commitment to universal, equitable access to COVID-19 vaccines, therapeutics, diagnostics and other health technologies was underscored – a commitment anchored in the understanding that this is an urgent moral imperative that requires immediate practical action. With this in mind, it was agreed to build on the longstanding commitment to trilateral cooperation between WHO, WIPO and WTO aimed at assisting and assisting all countries in assessing and implementing sustainable and integrated solutions to public health challenges.

Within this existing cooperation framework, it was agreed to strengthen and focus our support in the context of the pandemic through two specific initiatives – the three agencies will work together to organize practical capacity building workshops to facilitate the flow of updated information on current developments in the pandemic and responses, to achieve equal access to COVID-19 health technologies. The aim of these workshops is to strengthen the capacities of political decision-makers and experts in the member governments in order to counter the pandemic accordingly. The first in the series will be a technology transfer and licensing workshop scheduled for September.

Long COVID concerns

According to government data, more than 2 million adults in England have experienced coronavirus symptoms such as difficulty breathing and fatigue for over 12 weeks. It’s double the previous estimate for long covid. Research in the React-2 study, which has not yet been peer-reviewed, found that 37.7% of those who had symptomatic Covid had at least one symptom for 12 weeks or more, while 14.8% had three or more persistent symptoms Exhibited symptoms. “The scale of the problem is quite alarming,” said Professor Kevin McConway, Professor Emeritus of Applied Statistics at the Open University. On Wednesday (June 23), more than 16,000 new confirmed Covid cases were reported in the UK, the highest daily value since early February. The latest figures showed an additional 19 people had died within 28 days of testing positive for Covid-19, bringing the total to 128,027 in the UK. While the death toll remains relatively low, the sharp spike in reported cases appears to make it less likely that ministers will lift most of the remaining Covid restrictions before the current four-week delay ends on July 19.

Switzerland should open again

While countries like the UK are postponing their planned lifting of restrictions (in the case of the UK by July 19), Switzerland has announced an even more extensive lifting of restrictions than previously planned. Citizens no longer have to work from home; they do not have to wear masks or social distance at cultural and sporting events; and mass events can take place with no limit on the number or need for masks if coronavirus certificates are required.

And that’s all from EAPM for this week – have a nice weekend, stay safe and sound and don’t forget to sign up Here, and download your agenda Here, for the EAPM-EU Presidential Conference on July 1st.

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