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Welcome, health colleagues, to the European Alliance for Personalised Medicine (EAPM) update – there is controversy afoot concerning access to new medicines across Europe, doubts expressed over sufficiency of COVID testing alone for foreign travel, and the end of the Medical Device Regulation’s transition period, writes EAPM Executive Director Dr. Denis Horgan.
Stark divide on access to new medicines globally and in Europe
The coronavirus pandemic is far from over, WHO Director-General Tedros Adhanom Ghebreyesus stressed this week, as he lamented new variants, vaccines shortages, and a global disparity in access to inoculations.
“There is a huge disconnect growing, where in some countries with the highest vaccination rates, there appears to be a mindset that the pandemic is over, while others are experiencing huge waves of infection,” Tedros said. He expressed further concern about areas experiencing a continued high number of COVID-19 cases and places that had previously made progress are facing a new wave of cases and hospitalization. “The pandemic is a long way from over,” he said, “and it will not be over anywhere until it’s over everywhere.”In the fight against the coronavirus, some countries are faring better than others. In the United States, for example, cases have been dropping as more and more people get vaccinated.
President Joe Biden has set a goal to have at least 160 million Americans fully vaccinated by the July Fourth holiday. But in India, a second wave of COVID-19 has been devastating, killing thousands of people a day and setting world records for daily infections. Medical facilities have started to run out of oxygen, ventilators and beds, and workers have been stretched thin.
Countries in Northern and Western Europe access new medicines much more quickly than their Southern and Eastern European neighbors, with patients in some countries waiting more than seven times longer, according to research.
Access is the fastest in Germany, with an average of 120 days between marketing authorization and availability in the country, while in oncology, several countries — Poland, Lithuania, Romania, Slovakia Bosnia, Latvia, Iceland, Macedonia and Serbia — have no availability to new cancer medicines that were approved in 2019.
Meanwhile, while there was a much smaller number of orphan medicines approved in 2019, over half of the countries in the study hadn’t made any of these medicines available in 2020.
ECDC warns EU: Testing alone not enough to ensure safe travel
The European Centre for Disease Prevention and Control (ECDC) doesn’t think that only testing for COVID-19 to avoid entry restrictions for travellers in the EU is enough to prevent the possible spread of COVID-19 from incoming travellers. Speaking on the matter, ECDC Director Andrea Amon explained that only a portion of the EU’s population has received COVID-19 vaccines, meaning that the virus is still active and “testing alone doesn’t do the trick” for Europeans to travel freely, SchengenVisaInfo.com reports.
“We should keep in mind that the proof of a full-course vaccination, prior infection or lack of current infection as defined by a PCR [test], which are the three elements that are included in the certificate, have very different levels of certainty regarding the risk of the individual,” Ammon added.
The European Council and Parliament recently reached the agreement to establish the EU Digital COVID-19 Certificate, which will serve as evidence to prove if the holder has been vaccinated against the virus, has recovered from the disease in the recent months or tested negative for COVID-19 within the timeframe set by the EU destination country. These three are expected to be individual certificates and ease citizens movement across Europe.
MDR transition period ends
As of 26 May — after being delayed from 2020 — the Medical Device Regulation’s (MDR) transition period ended. Serge Bernasconi, MedTech Europe’s CEO, said he planned to open a half bottle of champagne to mark the occasion. “You will not see the full effect of the new regulation on May 26,” Bernasconi said, underscoring the fact that many legacy devices were recertified so as to remain on the market until 2024. “It’s only half a bottle of champagne,” Bernassconi said, “because I continue to believe there is still a lot to be done to make the system really operational.”
“Please don’t believe or think that this critical date is like an end — that’s what worries me the most,” Bernasconi said. “Please do not divert resources away from [the MDR], while at the same time, please pay enormous attention to what’s happening for IVDs. People might not see it, because there’s this huge medical device thing in front — but this thing is coming.”
Parliament committee endorses COVID certificates deal
The Civil Liberties Committee has endorsed the EU digital Covid Certificate package with 52 votes in favour, 13 votes against and 3 abstentions (EU citizens) and with 53 votes in favour, 10 votes against and five abstentions (third country nationals). The EU Digital Covid Certificate will be issued by national authorities and be available in either digital or paper format.
A common EU framework will allow member states to issue certificates that will be interoperable, compatible, secure and verifiable across the EU. More information here. LIBE Chairman of the Civil Liberties Committee and rapporteur Juan Fernando López Aguilar (S&D, ES) said:
“The Parliament started negotiations with very ambitious objectives in mind and has managed to achieve a good compromise through painstaking negotiations. The text voted today will ensure that freedom of movement will be safely restored across the EU as we continue to fight this pandemic, with due respect for the right of our citizens to non-discrimination and data protection.”
Update from the 74th World Health Assembly
A new resolution urges member states to raise the priority given to the prevention, diagnosis and control of diabetes as well as prevention and management of risk factors such as obesity. It recommends action in a number of areas including: the development of pathways for achieving targets for the prevention and control of diabetes, including access to insulin; the promotion of convergence and harmonization of regulatory requirements for insulin and other medicines and health products for the treatment of diabetes; and assessment of the feasibility and potential value of establishing a web-based tool to share information relevant to the transparency of markets for diabetes medicines and health products. Delegates asked WHO to develop recommendations and provide support for strengthening diabetes monitoring and surveillance within national noncommunicable disease programmes and to consider potential targets. WHO was also asked to make recommendations on the prevention and management of obesity and on policies for diabetes prevention and control More than 420 million people are living with diabetes, a number that is expected to rise to 578 million by 2030. One in two adults living with diabetes type 2 are undiagnosed. Globally, 100 years after the discovery of insulin, half of the people with type 2 diabetes who need insulin are not receiving it.
Vaccine for children aged 12 to 15 expected to get green light from European Medicines Agency
The first COVID-19 vaccine for children aged 12 to 15 is expected to be given approval by the European Medicines Agency (EMA) today (28 May). The vaccine, made by Pfizer BioNTech, has already been given the green light by the FDA in the United States. The EMA will hold a top-committee meeting tomorrow to give its final assessment on the vaccine. The National Immunisation Advisory Committee (Niac) will examine evidence around the vaccine before recommending whether or not it should be rolled out here.
It could mean the jab is offered to secondary school students before the start of the next academic year. Read More Fishing crews stage port protest to highlight problems facing industry It comes as it emerged the cyber attack on the HSE has delayed vaccination appointments for some people at high risk of COVID-19 due to underlying illness.
Those aged 16 to 64, whose GP is not involved in administering the vaccine, were due to be referred by their doctors instead of registering for their vaccination jab on an online portal. However, because of the cyber attack this has been put on hold and the current portal is only open to people over 45. The HSE is attempting to put an alternative system in place for this group.
And that is all from EAPM – stay safe and well and have an excellent weekend, see you next week.
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