Making headway on molecular pathology in oncology

Good afternoon, and welcome to the European Alliance for Personalised Medicine (EAPM) update, writes EAPM Executive Director Dr. Denis Horgan.

Molecular diagnostics

EAPM was in Bulgaria on Saturday (1 October) to discuss the issue of molecular pathology in the second-largest city in Bulgaria, Plovdiv. With such notable guests as Dr. Savelina Popovska, Dr. Denis Horgan himself and Svitlana Bachurska, subjects included Molecular Pathology in Oncology – the Place and Role of Precision Diagnosis of Cancer, Advances and implementation of molecular pathology in oncology in the EU and Keys to personalized therapy of breast cancer and lung cancer. 

Policy developments should reflect the evident need to drive access, diagnosis, innovation, investment and research forward and redress the inequalities across Europe and among different populations and pathologies. 

An overall cancer plan—desirable in itself—is not sufficient, as a cancer plan is needed for each type of cancer. Nevertheless, at a general level, it is evident across the board that cancer registries are currently inadequate, non-standardised and lacking essential clinical data. 

There are vast differences in incidence and survival of many cancers from state to state, and these differences are also reflected in screening and access to appropriate therapies and expertise. These regional variations are not cultural but the result of policy and political will to look beyond cost-benefit calculations. All countries should have the same objective of equal access to optimal care and equal outcomes. Moves are needed to systematically speed the process between early symptoms and diagnosis and between diagnosis and treatment

Clearly, co-ordination and support is needed to develop cross-border solutions for sharing expertise and linking genomic and other health data Timely detection of biomarkers allows patients to avoid treatments which won’t work for them, and where appropriate benefit from the targeted treatments that have been delivered from advances in science. The big challenge is to ensure that patients have access to the right testing at the right time, and this is not given enough attention in the EU debate. The Bulgaria event was geared towards doing just that which EAPM will be following up at the EU level as well as in other member states in the weeks ahead. 

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Specialty training in France

In order to begin a medical specialization in France, you must be in your 6th year of studies and take the Épreuves Classantes Nationales (ECN). After passing the exam and receiving your rank, you can choose a specialty and the place where you would like to do your residency. Since 2005 it has in fact been possible to practice medicine in France while holding a medical diploma issued in another European country. 

But since 2013, measures to bring diplomas into compliance were strengthened, and it’s no longer very easy to be able to practice medicine in France with a foreign diploma. This is why, if you’re planning on living in France, it can be a good idea to do your residency in France and thus avoid any regulatory obstacles. 

Furthermore, getting your medical training in France helps you to better absorb the French medical culture, get used to the local practices, as well as better understand the territorial needs, which differ greatly from specialty to specialty and region to region, given that France suffers from an imbalance between “medical deserts” in some parts, and an overabundance of physicians in other parts of the country.

Overdue clinical trials

Medicines regulators throughout Europe are failing to meet regulatory standards of clinical trial reporting, with the biggest countries faring worst of all. Some European medicine regulators are working to persuade investigators to meet the requirement to make results public within 12 months of trial completion, but others appear to have taken “little or no action,” say campaigners.

A report by non-profit campaigning group TranspariMED and eight other organisations, scheduled for release on 3 October and shared exclusively with The BMJ ahead of publication, identifies at least 5488 results for which regulators are “unambiguously responsible” that are lacking. This is based on “very conservative assumptions,” and is depriving medical research of vital information, costing patient lives, and wasting public money, the report says. The report, Missing Clinical Trial Data in Europe, covers only single country trials approved before 2016 to make it clear where the blame lies.

Grim winter over flu and COVID-19

The twin threats of the coronavirus and influenza are rearing their heads once more.The European Commission is proposing concrete measures to avoid a surge of COVID-19 cases in the upcoming autumn and winter season. The Commission is urging member states to put the necessary strategies and structures in place, including for COVID-19 vaccination and surveillance, to respond to future outbreaks in a fast and sustained manner. The main aim of the actions proposed by the Commission is to increase the uptake of vaccines, including adapted and new vaccines, and to ensure that all citizens are well protected.

Countries in the European Region adopt first-ever digital health action plan

Health ministers and delegates from WHO/Europe’s 53 member states have adopted the Region’s first-ever digital health action plan – an ambitious agenda that will leverage digital transformation in Europe and central Asia with the aim of improving people’s health and well-being. 

Meeting on 12 September 2022 at the 72nd session of the WHO Regional Committee for Europe, the ministers and delegates approved a resolution recognizing the critical role and potential of digital tools in the health sector, and building on the lessons learned during nearly 3 years of the COVID-19 pandemic. 

Digital health is among the 4 flagship areas of the WHO European Programme of Work 2020–2025 (EPW) – “United Action for Better Health in Europe”. The new action plan is a concrete step towards making the EPW a reality by leveraging digital tools to advance universal health coverage, protect people from health emergencies, and promote health and well-being in the Regio

Europe's generic drugmakers say they may cut output due to energy bills

Europe's drugmakers have warned they may stop making some cheap generic medicines because of surging electricity costs and are calling for an overhaul of the way they are priced, the latest industry to seek help as the energy crisis deepens.

The bloc's 27 energy ministers are meeting on Friday to seek agreement on measures to ease the energy crunch in Europe, with a levy on windfall profits of fossil fuel companies and a gas price cap on the table. A spokesperson for the EU's Czech presidency - responsible for preparing and chairing the meeting - confirmed the receipt of the letter but said the Friday talks were meant to approve proposals by the bloc's executive European Commission. 

Latest Updates UK's Truss makes U-turn on tax after week of market turmoil Credit Suisse shares slip despite moves to soothe investor concerns Credit Suisse executives reassure investors after CDS spike, Financial Times reports Credit Suisse euro bonds drop more than 5 cents, hit record lows These have so far not included solutions aimed at drugmakers specifically. The letter was also addressed to the Commission, which said it would reply "in due course".

"Higher energy costs just eat all of the margins of many makers of essential medicines in the fixed price system that we operate under in Europe," he said. The issue centres on the pricing regime. Off-patent medicines are typically sold by low-cost drugmakers at prices set by national health agencies or insurers' associations, which frequently also cut prices. 

Generics account for about 70% all dispensed medicines in Europe, many of them to treat serious conditions such as infections or cancer, but make up only 29% of the region's drug bills, according to the lobby group. The surge in energy costs risks undermining a recent push to boost medicines production in Europe and make the region more self-sufficient after the COVID-19 pandemic exposed a dependence on suppliers abroad and led to a breakdown of certain supply routes.

COVID-lockdown measures in China and the war in Ukraine have made matters worse for logistic and raw material supplies. Drug supply shortages, which at times disrupt patient care when alternative sources are not available, have a decade-long history in the European off-patent generic drug sector, where pressure on prices by cash-strapped health systems allows only the most cost-efficient suppliers to survive. While makers of patented innovative drugs are also typically banned from raising prices after a reimbursement rate has been set, the much higher margins keep most of those products profitable.

Standard infusions for hospitals are among the most energy intensive drugs to produce because they need to be heated and cooled for sterility. The same goes for the fermentation process behind commonly used antibiotics and therapeutic hormones, said van den Hoven.

And that is all for now from EAPM – stay safe and well, and enjoy your week.

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