Good afternoon, health colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update – there is much to discuss, on beating inequalities in cancer treatment, clinical data transparency and, importantly, planning for summer holidays writes EAPM Executive Director Dr. Denis Horgan.
Commissioner says EU cancer plan must ‘break the silence’ on women’s cancers
There is a large inequality of access to women’s cancer services and treatments across the EU, according to the bloc’s health chief, who highlighted the role of Europe’s Beating Cancer plan in bridging these disparities. Speaking during a webinar, Health Commissioner Stella Kyriakides said there is a need to “break the silence” and talk openly about gynaecological cancers.
The EU, she added, has “to assure that all women in all corners of the EU, get the support, have access to the screening and the vaccination, the information and the multidisciplinary care that they should be having”.
Her hopes are on Europe’s beating cancer plan, which must bring “real change”. “This is what European citizens expect from us. And I also believe that we don’t have a right to fail them. We have an opportunity and we need to seize it,” Kyriakides said. Europe’s Beating Cancer Plan was set in 2020 to tackle the entire disease pathway, from prevention to treatment, with the goal to equalise access to high-quality care, diagnosis and treatment across the bloc.
About 40% of cancer cases are preventable through effective cancer prevention strategies. The commissioner added that the EU cancer plan “aims to offer breast cancer screening to 90% of people who qualify for it by 2025”.
EMA chief sceptical about waiving patents as answer to vaccine inequity
The head of the European Medicines Agency expressed scepticism that waiving patents on coronavirus vaccines will bring about equitable access, saying that instead the answer was increasing distribution and availability.
In an interview with several national European newspapers, EMA Executive Director Emer Cooke said that she firmly believes in “equitable access to vaccines and that nobody is safe until we are all safe,” when asked about the U.S. proposal for a vaccine patent waiver.
“For me, however, the way to solve this problem at the moment is to increase the distribution and availability of vaccines,” she said, pointing to a significant number of doses set to be available over the next several months.
Cooke said that the focus should be on “enabling innovation.” “None of our existing vaccines would have come about if there hadn’t been an environment that made innovation attractive,” she said.
Despite this, Cooke conceded that in the “long term” the debate on patent protection should be carried out.
More action on rare diseases
Any disease affecting fewer than five people in 10,000 in the EU is considered rare. Although this might appear small, it translates into approximately 246,000 people. Most patients suffer from even rarer diseases affecting 1 person in 100,000 or more. Approximately 5,000-8,000 distinct rare diseases affect 6-8% of the EU population i.e. between 27 and 36 million people.
Public Health Policy Director Anna Kole has said that the successful launch of Europe’s Beating Cancer plan had provided inspiration for the idea of creating a dedicated action plan for rare diseases.
Meanwhile, the Commission is moving on several different fronts to improve rare disease treatment in the EU. An impact assessment evaluating proposals to change EU regulations for medicines for rare diseases and for children is expected to run until the first quarter of next year. That will open the door to new legislative changes. And creation of a European health data space will allow pooling data from rare disease patients across different member countries.
Kole said that an action plan would allow better coordination across the disparate fields that the Commission is acting on, as well as the introduction of new flagship initiatives.
“If there’s one disease area where EU added value can’t be more clearly demonstrated, it’s rare diseases,” said Kole, who pointed to the benefits of allowing patients to move across borders for specialist treatment, or for facilitating data sharing throughout the bloc, as examples.
The EU supports research into rare diseases through Horizon 2020, the EU Framework Programme for Research and Innovation. Horizon 2020 is the biggest EU Research and Innovation programme ever, with nearly €80 billion of funding available over 7 years (2014 to 2020). Close to €900 million, is available to more than 160 collaborative projects related to rare diseases.
Rich-poor vaccine inequity
The disparity in access to COVID-19 vaccines between rich and low-income countries has become impossible to ignore; according to UNICEF data, 86% of all doses given worldwide up to 30 March were administered to those in high- and upper-middle-income countries, while just 1% of jabs have been given to those in the world’s poorest.
Low-risk groups in the UK, US and Israel are becoming eligible for jabs, while vulnerable populations elsewhere remain at risk of contracting the virus. The hoarding of vaccines by wealthy countries, as the pandemic ravages economically disadvantaged nations, has brought the issue of vaccine patents to the fore.
Biotechnology Innovation Organization wrote in the Economist that the proposal “undermines the very system that produced the life-saving science in the first place”, and “destroys the incentive for companies to take risks to find solutions for the next health emergency”.
Regulators and WHO call for clinical data transparency
World regulatory authorities are calling for increased transparency from the pharmaceutical industry in how they report and give access to clinical trial data. In a joint statement, the World Health Organization (WHO) and the International Coalition of Medicines Regulatory Authorities (ICMRA) cited need for “wide access to clinical data for all new medicines and vaccines”.
Data related to a therapy or vaccine “must be published at the time of finalization of the regulatory review,” they said, regardless of whether the decision is positive or negative. “It cannot be justified to keep confidential efficacy and safety data of a medicine available on the market, or which has been refused access to the market.”
The two bodies cited “overriding public health interest” in their statement, which called for pharmaceutical companies to report clinical trial results without redacting information that would otherwise be confidential because of commercial reasons. Only personally identifying information and individual patient data should be redacted from publicly available clinical trial data, wrote WHO and ICMRA.
People can ‘start thinking about Europe summer travel’
People can start thinking about summer holidays in Europe on condition of being vaccinated, the EU has said, as its planned digital travel 'health pass' is on track for use from mid-June. The plan is that a European-wide health pass will be launched at the same time across the EU, and countries that do not have the resources to put it in place will be supported by the Commission, to avoid delays. Internal Market Commissioner Thierry Breton said: “I seriously believe that we can start thinking about [summer travel], probably like last year in Europe. “It will be important to open the continent gradually, and to be able to go on holiday. Everyone must go to get vaccinated. As soon as you are called, go to get vaccinated.”
Commission publishes open public consultation on the European Health Data Space
The Commission has published an open public consultation on the European Health Data Space (EHDS) - an important building block of the European Health Union. The EHDS aims to make full use of digital health to provide high-quality healthcare and reduce inequalities. It will promote access to health data for prevention, diagnosis and treatment, research and innovation, as well as for policy-making and legislation. The EHDS will place individuals' rights to control their own personal health data at its core.
The consultation will remain open for responses until 26 July 2021. Health and Food Safety Commissioner Stella Kyriakides said: ″The European Health Data Space will be a crucial component of a strong European Health Union. It will enable EU-wide collaboration for better healthcare, better research and better health policy-making. I invite all interested citizens and stakeholders to take part in the consultation and help us leverage the power of data for our health. This will have to rest on a strong foundation of non-negotiable citizens' rights, including privacy and data protection.″
And that is everything from EAPM for now – stay safe, stay well, have a terrific weekend, see you next week.