EAPM: Presidency bridging conference a great success, HTA compromise agreed and data on the agenda – EU Reporter

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

EAPM conference approaches - a reminder yet again...

The EAPM conference will act as a bridging event between the EU Presidencies ofPortugalandSlovenia.The conference is divided into sessions which cover the follows areas: Session 1: Generating alignment in the regulation of Personalized Medicine: RWE and Citizen Trus;Session 2: Beating Prostate Cancer and Lung Cancer - The Role of the EU Beating Cancer: Updating EU Council Conclusions on ScreeningSession 3: Health Literacy - Understanding Ownership and Privacy of Genetic Data and finallynot least,Session 4: Securing patient Access to Advanced Molecular Diagnostics.

Each session will comprise panel discussions as well as Q&A sessions to allow the best possible involvement of all participants, so now is the time to registerhere, and download your agendahere.

Battling cancer Parliaments key draft report

As mentioned in previous updates, the European Parliament has set up a special committee on beating cancer. It has published its first draft report on the EU Beating Cancer Plan on the last day, which has included a number of items which the EAPM has advocated for in the last months representing key issues representing themulti-stakeholder nature of its membership.

Subdivided into numerous articles, article 66 in the report is of particular attention to EAPM members, saying as it does that huge advances in biology have revealed that cancer is an umbrella term for more than 200 diseases, and that precision or personalised medicine can be made available through the drug targeting of various mutations.

The report also considers that precision or personalised medicine, consisting of a treatment choice based on individual tumour biomarkers, is a promising way to improve cancer treatment, and encourages member states to promote the implementation of regional molecular genetics platforms and facilitate equal and rapid access to personalised treatment for patients.

In addition, article 48 in the draft report calls on the Commission to promote, and on member states to strengthen, the role of general practitioners, paediatricians and primary care professionals, given their importance in patient referral to diagnostic tests and oncology specialists, as well as during cancertreatment and follow-up care; calls for the development of multidisciplinary decision-making in the framework of dedicated concertation meetings bringing together various cancer specialists.

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

Perhaps most importantly, article 87 sees an urgent need for a European charter of the rights of cancer patients; calls for this charter to define the rights of cancer patients at every stage of their care pathway, i.e. access to prevention, initial diagnosis and throughout their treatment, and for it to apply equally to all EU citizens, regardless of the country or region in which they live.

In addition, article 105 looks to the Cancer Diagnostic and Treatment for All flagship and puts a spotlight on the need for the use of the next generation sequencing technology for quick and efficient genetic profiles of tumour cells, allowing researchers and clinicians to share cancer profiles and apply the same or similar diagnostic and therapeutic approaches to patients with comparable cancer profiles.

EAPM looks forward with enthusiasm to all forward progress being made in the fight against cancer. In this context, EAPM is working on two publications with its experts on NGS and RWE which will provide additional input/guidance to the European politicians which EAPM is working with.

HTA political agreement

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

Welcoming the agreement, Commissioner for Health and Food Safety Stella Kyriakides made the following statement: I am very pleased that the European Parliament and the Council have reached a long-awaited political agreement on the Health Technology AssessmentRegulation. The Regulation will be a significant step forward to enable joint scientific assessments of promising treatments and medical devices at EU level.

Progress on vaccinations welcomed, but further effort urged

The European Council welcomes the good progress on vaccination and the overall improvement in the epidemiological situation, while stressing the need to continue vaccination efforts and to be vigilant and co-ordinated with regard to developments, particularly the emergence and spread of variants.

According to the draft European Council conclusions for the June 24-25 meeting, the Council stated that it reaffirms the EUs commitment to international solidarity in response to the pandemic.

All producing countries and manufacturers should actively contribute to efforts to increase worldwide supply of COVID-19 vaccines, raw material, treatments and therapeutics, and coordinate action in case of bottlenecks in supply and distribution, the draft text declares.

The conclusions also reference recent agreements on travel within the EU, stating that member countries would apply these measures in a manner that ensures the full return to free movement as soon as the public health situation allows. The Council also plans to welcome the decision to set up a special session for the World Health Assembly to discuss a pandemic treaty, with the EU saying that it will continue to work toward a goal of a treaty.

WHO, WIPO and the WTO agree on intensified co-operation to tackle COVID-19 pandemic

On 15 June, the directors general of WHO, WIPO and the WTO met in a spirit of co-operation and solidarity to map out further collaboration to tackle the COVID-19 pandemic and the pressing global challenges at the intersection of public health, intellectual property and trade.Acutely conscious of the shared responsibility to communities across the world as they confront a health crisis of unprecedented severity and scale, the organizations pledged to bring the full extent of the expertise and resources of the respective institutions to bear in ending the COVID-19 pandemic and improving the health and well-being of all people, everywhere around the globe.

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 in need of immediate practical action.In this spirit, there was an agreement to build further on the long-standing commitment to WHO-WIPO-WTO Trilateral Cooperation that aims to support and assist all countries as they seek to assess and implement sustainable and integrated solutions to public health challenges.

Within this existing cooperative framework, it was agreed to enhance and focus our support in the context of the pandemic through two specific initiatives - the three agencies will collaborate on the organization of practical, capacity-building workshops to enhance the flow of updated information on current developments in the pandemic and responses to achieve equitable access to COVID-19 health technologies. The aim of these workshops is to strengthen the capacity of policymakers and experts in member governments to address the pandemic accordingly.The first workshop in the series will be a workshop on technology transfer and licensing, scheduled for September.

Long COVID concerns

More than 2 million adults in England have experienced coronavirus symptoms lasting over 12 weeks, such as respiratory problems and fatigue, government data suggests. It is double the previous estimate for long Covid. The research by the React-2 study, which has not yet been peer-reviewed, found that 37.7% of those who had symptomatic Covid experienced at least one symptom lasting 12 weeks or more, while 14.8% had three or more persistent symptoms. The scale of the problem is quite alarming, said Professor Kevin McConway, emeritus professor of applied statistics at the Open University. It comes as more than 16,000 new confirmed Covid cases were reported in the UK on Wednesday (23 June), the highest daily figure since early February. The newest figures showed another 19 people had died within 28 days of testing positive for Covid-19, bringing the UK total to 128,027. While death figures remain relatively low, the sharp rise in reported cases would appear to make it less likely that ministers will scrap most remaining Covid restrictions before the current four-week delay ends on 19 July.

Switzerland to re-open

While countries such as the UK delay their planned lifting of restrictions (as it stands, until 19 July in the case of the UK), Switzerland has announced an even more wide-ranging lifting of restrictions than previously planned. Citizens will no longer be required to work from home; they wont have to wear masks or social distance at cultural and sporting events; and mass events can go ahead without restrictions on numbers or the need for masks if theres a requirement for coronavirus certificates.

And that is all from EAPM for this week have a lovely weekend, stay safe and well, and dont forget to registerhere, and download your agendahere,for the EAPM EU Presidency conference on 1 July.

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EAPM: Presidency bridging conference a great success, HTA compromise agreed and data on the agenda - EU Reporter