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The annual Presidency conference of the European Alliance for Personalised Medicine (EAPM) is only six days away and this exciting event space rapidly selling out. The event will pull together leading experts in personalised medicine drawn from patient groups, payers, healthcare professionals plus industry, science, academic and research representatives, writes EAPM Executive Director Dr. Denis Horgan.
Presidency Conference, April 5th
The conference is entitled: Determining a Path for Optimal Integration of Access & Diagnostics for All & Public Health Genomics.
Better use of our increasing understanding of the genome is recognised as being one of the main determinants of future improvement in healthcare as part of personalised medicine and is already being increasingly deployed in routine clinical practice. To register please click here and to view the agenda, please click here.
Sequencing of all the genetic material of an individual, whole genome sequencing, is becoming an affordable and achievable test for clinical use and creates a powerful resource for research.
Generally speaking, the expanding and very swiftly moving world of genomics in healthcare has opened up many new opportunities, but evaluations have to be done on the economics of the new technologies. This will also come under the spotlight at the conference. There is a clear need to provide value for money in cash-strapped healthcare systems that are struggling with ageing populations, dealing with a new clinical trial paradigm in the wake of the discovery of more-and-more rare diseases, and collapsing under the weight of a huge increase in co-morbidities.
However, evidence suggests that diagnoses are increasing, and improving, via the use of molecular diagnostics and other genetic breakthroughs, with costs coming down and a growing confidence, arguably, as the public becomes more aware of the potential to improve health in this and following generations.
Yet overall costs still need to come down further, and a better data collection, storage and sharing infrastructure needs to be put in place. On another note, there are challenges in how we ethically collect and share Big Data for medical purposes and technological challenges in how we store, classify and interpret it for the benefit of the EU’s patients, but the potential is clear.
In genomic medicine traditional models of consent and information governance are not always appropriate because the longstanding distinction between research and clinical care becomes blurred and because of the identifiable nature of genomic data.
Policy- and law-makers need to get up-to-speed with the developing technologies surrounding genomic data, not least by Member States developing approaches to embedding consent in clinical care as part of the EU’s social contract.
Meanwhile, EU governments should look closely at the implementation of the General Data Protection Regulation for guidance, legally and ethically. The interface between basic and clinical research needs to be strengthened and explicitly funded, while education and skills in the data sciences needs to be dramatically expanded.
Each session will aim to develop concrete policy asks linked to bringing life to the EU Council Conclusions from Luxembourg on patient access to personalised medicine, the European Beating Cancer plan, pharma legislation and the EU health Data Space.
To register for the event on April 5th, please click here and to view the agenda, please click here.
Clinical Trials
Over the course of the coronavirus pandemic, it’s become clear that poorer people and racial minorities have been disproportionately affected by COVID-19. And the UK wants World Health Organization countries to sign off on a plan at the World Health Assembly in May to beef up their ability to carry out innovative and efficient clinical trials. The impact of the Covid-19 pandemic threatens to reverse decades of progress made towards gender equality, according to a global study that reveals women have been hit much harder socially and economically than men.
Previously, coronavirus-related gender disparity studies have focused on the direct health impacts of the crisis. It is well known, for example, that across the globe men have experienced higher rates of Covid cases, hospitalization and death. However, until now, few studies have examined how gender inequalities have been affected by the many indirect social and economic effects of the pandemic worldwide.
Clinical trial protocol deviations ‘unavoidable’ for Ukraine studies
European regulators are warning that clinical trial protocol deviations are “unavoidable” for studies operating in Ukraine amid the Russian invasion, and companies should consider being flexible as they have been during the COVID-19 pandemic to keep vital research going. The advice from the European Commission, the European Medicines Agency and the Heads of Medicines Agencies comes after sponsors in Ukraine or close to the situation asked for guidance regarding trial records, documentation, data collection, protocol deviations and the potential impact missing data could have on methodology. New research shows that more than 4% of global trials have had to be halted or paused due to instability in the region. Most recently,
Parliament plans July vote for Digital Markets Act
The European Union (EU) will soon be handed sweeping new rules to regulate the conduct of the largest digital platforms with the long-awaited Digital Markets Act (DMA). Following 15 months of intense negotiations on amendments to the original Proposal, the presidents of the main EU institutions (the Parliament, Council, and Commission) reached a political agreement on the final text of the DMA on March 24, 2022. The final vote is planned for July 2022, with the rules expected to come into effect in October 2022.
It is expected that designated gatekeepers will need to comply by early 2024. The DMA is classified as a regulatory tool and will apply in parallel with the antitrust rules and other national-level enforcement efforts. The EU is also finalizing several other regulatory initiatives (the Digital Services Act, the Data Act, and the AI Act). Companies wishing to operate in Europe will have to navigate an increasingly complex web of rules and make compliance design a priority. In a “race to the bottom,” these rules could also set the de facto global standard for tech platforms, as other jurisdictions seek to model their own digital regulations on the EU’s example.
A vote for CARE
Members of the European Parliament voted nearly unanimously today (31 March) in favor of a Commission proposal to make the 2014-2020 cohesion policy rules more flexible, making it easier to reallocate available funds to respond to the growing needs of those fleeing Ukraine. The Cohesion’s Action for Refugees in Europe (CARE) will help cover, among other things, refugees’ access to temporary accommodation, medical care, and food and water. Since Russia started its invasion of Ukraine on 24 February 24, more than 3.8 million refugees have left their homes in Ukraine and headed toward other countries.
On 2 March, the European Commission activated the Temporary Protection Directive to provide quick and effective assistance to people fleeing the war in Ukraine, SchengenVisaInfo.com reports. According to this directive, all persons fleeing the war are given temporary protection in the EU, which means they are offered a residence permit, access to education and the labour market. Ukrainian refugees have the right to temporary protection in any EU country if refugees from Ukraine have been permanent residents of Ukraine and have left the country to escape the war from 24 February. Temporary protection will last for at least a year, at least until 4 March 2023, but may be extended depending on the situation in Ukraine.
If the reasons for granting temporary protection continue, for Ukrainian refugees, temporary protection will be automatically extended for six months twice, i.e. until 4 March 2024. Ukrainian citizens have the right to move freely within the Union after being admitted to the territory for a period of 90 days.
WHO says COVID severity will decrease over time
The World Health Organization on Wednesday (30 March) released an updated plan for COVID-19, laying out three possible scenarios for how the pandemic will evolve this year. “Based on what we know now, the most likely scenario is that the COVID-19 virus continues to evolve, but the severity of disease it causes reduces over time as immunity increases due to vaccination and infection,” Director-General Tedros Adhanom Ghebreyesus said during a briefing.
However, the WHO head cautioned that periodic spikes in cases and deaths may occur as immunity wanes, which may require periodic boosting for vulnerable populations. Talking about the other two potential scenarios, Tedros said either less severe variants will emerge and boosters or new formulations of vaccines will not be necessary, or a more virulent variant will emerge and protection from prior vaccination or infection will wane rapidly.
And that is everything from EAPM for now – remember, you can view the EAPM event on Pharmaceutical Legislation agenda here and to register, click here. Stay safe and well, and enjoy your weekend.
—
Dr. Denis Horgan, PhD, LLM, MSc, BCL
EAPM Executive Director,
Chief Editor, Public Health Genomics
EAPM, Avenue de l’Armee/ Legerlaan 10,
1040 Brussels, Belgium
Ph: + 386 30 607 281
Website: www.euapm.eu
About EAPM
The European Alliance for Personalised Medicine brings together Europe’s leading healthcare experts and patient advocates to improve patient care by accelerating the development, delivery and uptake of personalised medicine and diagnostics.
It is calling for the European Commission, the European Parliament and EU member states to help improve the regulatory environment so that patients can have early access to personalised medicine, and so that research is boosted.
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