Connect with us

Cancer

#WorldCancerDay highlights need for cost-effective approaches to new medicines

Published

on

World-Cancer-DayBy European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan

This week, on 4 February to be exact, sees World Cancer Day 2016, and it seems that, according to the World Health Organization, new cases of cancer globally are expected to increase by 70% over the next 20 years, from around 14 million to 25m.
Yet while the rain might seem to be tumbling down incessantly in Brussels, there will surely come a time when, in the metaphorical words of the song, we “can see clearly now, the rain has gone” - and not only in cancer, but also in diabetes and many other disease areas.
But, of course, there are cost issues and one ket area is to try to address them. Producing medicines has not become any cheaper. If anything, the opposite is true with development costs rising almost exponentially in recent decades.
Figures suggest that the average new medicine takes more than €1 billion and from ten-15 years to get from ‘bench to bedside’. At the same time, markets allowing for such heavy investments to be recouped are becoming much smaller – as a direct natural result of the increase in personalization of treatment.
So does the fact that it’s more expensive to produce medicines for fewer people necessarily mean that medicines are (or will be) unaffordable for health-care systems? The answer to this from the Brussels-based European Alliance for Personalised Medicine (EAPM) is 'no'. At least not necessarily.
EAPM believes that a key challenge for health care systems is to manage medicines spending – yet they must still also deliver on innovation. The Alliance has always maintained that, when and where it is possible to treat a patient to target using an older cheaper medicine, then it should be done.
One the other hand, if a patient needs a more modern treatment, access should be provided at reasonable prices that reflect both the added value and the volume across the market – with low volume treatments, naturally commanding a higher price. Getting this balance right will be tough, but will ensure that everyone wins.
This mantra has been taken up by others. Said Minister of Public Health for the Netherlands Edith Schippers: “Constraining costs to provide optimal care in the future is in our best interest, to work together with the industry, healthcare insurers, healthcare providers and the patient. This asks for clear roles and choices in the way that we arrange our pharmaceutical care. Nationally where possible and where needed also in Europe.
“Only in this way can we work towards a system that provides access to valuable medication for the need of the patients,” the minister added.
The Alliance, which brings together patients, medical professionals, health-care planners, scientists, industry and researchers, is working with the last EU Presidency Luxembourg and the current one, The Netherlands, on a variety of topics (including the former’s recently presented Council Conclusions on Personalised Medicine).
The stakeholder group believes that there has never been a better time to grasp the opportunities in cancer prevention using the latest discoveries in “omics” – including genomic science.
Due to these advances, for example, knowledge of common variants related to cancer risks has leaped from five to more than 450 and, genetically, scientists know a great deal more about what makes individuals susceptible.
Personalised medicine utilizes research, data and up-to-the-minute technology to provide better diagnostics and follow-up for citizens than is currently the case. It uses genetic information to discern whether a particular drug or regime will work for a particular patient and assists clinicians in deciding which treatment will be the most effective. It can also have a huge impact in a preventative sense.
Earlier diagnostics and earlier treatment have many benefits, among them fiscal, because while cost is a major issue – and there are key questions about the cost-effectiveness of new and even existing treatments – better diagnostics will ease the burden on health-care systems in two ways.
Firstly, it will allow a more preventative approach in that gene technology will flag up the likelihood of a particular individual developing a particular disease and provide a good idea of how it will develop, thereby encouraging early intervention.
Health Minister Schippers has not-coincidentally taken a line that EAPM has advocated during the last few years and, as recently as 29 January, in a letter to the Dutch Parliament, she wrote on the topic of ‘New medication quick access and acceptable prices’.
She explained: “Medication plays an important role in the quality of life of many Dutch citizens” adding that people recover faster thanks to medication, can keep working despite their disease and live independently.”
Concentrating on her own member state (although it is equally true for the rest of the EU-28) she gave the example that “More than a million people with diabetes can stay active in society, with the help of medication…More than four million Dutch citizens with blood pressure lowerers and cholesterol inhibitors, decrease their risk of heart and coronary diseases. But also people with cancer, complex diseases or rare diseases have a better quality of life thanks to better medication.”
Schippers pointed out that, in the past few years “we have tried to constrain the costs of medicines,” adding that the “responsibility of cost is with health care providers and insurers” and that the ‘preference policy’ is for generic instead of brand medicines.
She added that the costs of medication (in the Netherlands) have been around 9% of total health expenditure the last few years. This is not a relatively large sum, overall.
She also noted that patients want new medication while noting that some innovative medications are only suitable for a small group of people, while not working for others.
“These medications get insufficient chances in the current market admission system, leading to delayed access, or non, to patients,” the minister said.
As EAPM has stressed many times, this is clearly a Europe-wide problem. Schippers echoes statements made in the Luxembourg Council Conclusions when she says that it is essential to keep innovative medication accessible at acceptable prices, while acknowledging that, “if medicines don’t have an added value for health care, then it should be clear that we are not prepared to pay high prices”.
Luxembourg’s Health Minister Lydia Mutsch, speaking at a high-level conference during the Duchy’s Presidency, said: “The challenge to be addressed is to put into place a framework which allows to deliver the right treatment to the right patient at the right moment, in accordance with the principle of universal access to high quality health care.”
The conference also concluded that personalised medicine’s integration into clinical practice and daily care is proving difficult given the many barriers and challenges to timely access to targeted health care that still exist as of today.
World Cancer Day is a timely reminder that much work remains to be done to improve the lives of 500 million potential patient across Europe’s member states.

Breast cancer

EU health chief: Access to gynaecological cancer treatment differs widely across EU

Published

on

There is a large inequality in 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.

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 block.

Inequalities across the bloc

However, access to cancer detection and treatment currently differs widely across the bloc. 

Antonella Cardone, director of the European cancer patient coalition (ECPC), said screening programs lead to a remarkable reduction in incidence and mortality but “there are major disparities in screening between the different EU member states”.

This means many women are not being diagnosed early enough when the disease is still treatable and “often curable”.

The highest incidence among all women cancers is breast cancer, which accounts for 88% of cancer cases among women. 

But the access to screening that helps early detection of cancer for people at risk ranges from 6% to 90% among member states. Screening for cervical cancer for people at risk ranges from 25% to 80% in the EU.

“These statistics represent […] early detection, which leads to early treatment, and life saved. Or late detection, which often leads to life lost,” said Kyriakides. 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.”

In addition to this, new European guidelines for breast cancer screening diagnosis are being finalised and will be launched at the end of June.

After several years, guidelines on colorectal and cervical cancer should be also released. 

They should “result in better screening and diagnosis, better information and awareness for women and better training for health workers”, Kyriakides said.

Treatment, as well as detection, is also unequal between member states. 

For example, survival rates following treatment for breast cancer vary by 20% among EU countries. 

“I am determined that all patients have the same opportunities for care, no matter where they live in the European Union. The cancer plan aims to support this goal,” Kyriakides said, adding that “psychological, social, nutritional, sexual counselling and rehabilitation programs” will be offered to patients.

More to be done to tackle women cancer

Detection and treatment are not the only parts of the plan that specifically focus on women. 

Human papillomavirus is another target. It causes cervical cancer, which is the second most common cancer among women aged 15 to 39.

The goal, Kyriakides said, “is to eliminate cervical cancer caused by the human papillomaviruses by vaccinating at least 90% of the EU target population of girls by 2030″. 

Romana Jerković, the Croatian socialist MEP and a member of the intergroup on cancer, said that although cervical cancer is preventable with immunisation “vaccination rates against the human papillomavirus are worryingly low in some European countries. It is about time that the member states wrap up their efforts and ensure that their target population is vaccinated”.

Kyriakides added that the plan also addresses “challenges faced by cancer survivors”. 

“We aim to launch the ‘better life for cancer patients’ initiatives, including the creation of a virtual European cancer patient digital centre. This will support the exchange of patient data, and monitoring of survivors’ health conditions,” she said. 

Jerković also highlighted the importance of digitalisation and better data management. 

“Better and faster exchange of the data and the information can be life-saving factors in someone’s treatment,” she said, adding that European health data space will play a huge role in cancer patients’ health data access. 

sra Urkmez, the previous co-chair of The European Network of Gynaecological Cancer Advocacy Groups (ENGAGe), warned that although Europe’s Beating Cancer Plan addresses the issues well, “it’s easier said than done”. She highlighted the importance of staying united “when it comes to such goals”.

Europe’s Beating Cancer Plan will have €4 billion of funding, including €1.25bn from the future EU4Health programme.

Continue Reading

Cancer

EAPM: Stronger together against cancer and with good data sharing

Published

on

Good morning, one and all, and welcome to the European Alliance for Personalised Medicine (EAPM) update – there is much positivity concerning the battle against cancer and the consultation on the health data sharing plan, so some refreshing good news after all the recent COVID-related despondency, writes EAPM Executive Director Dr. Denis Horgan.

Porto Declaration on Cancer Research

The Porto Declaration on Cancer Research was launched during the European Cancer Research Summit 2021, held on 3 May at the Portuguese Institute of Oncology (IPO) in Porto under the Portuguese Presidency of the Council of the European Union.

The declaration presented by Portuguese Minister Manuel Heitor is the result of the work done by several researchers, scientific and clinical leaders and political decision-makers, who have reinforced the need to broaden Europe's Beating Cancer Plan over recent months, particularly through extending and reinforcing the European network of Comprehensive Cancer Centres (CCCs), based on the reinforcement of three types of research infrastructure:

Translational research infrastructure
Clinical and prevention trial infrastructure
Outcomes research infrastructure

These infrastructure components are increasingly being deemed critical to prevention, early detection, diagnosis, treatment, monitoring disease treatment and patient support and assistance. National participation in the European network of Comprehensive Cancer Centres is led in Portugal by the “Porto Comprehensive Cancer Centre”, based in the Porto IPO, in partnership with its associated laboratory, i3S, which recently received funding of around EUR 15 million for new equipment under the North Regional Operational Programme.

The Porto Declaration on Cancer Research strengthens the commitment of the Trio Presidency of the Council of the European Union (Germany, Portugal and Slovenia) to significantly reduce cancer mortality by 2030, with a goal of 75% of cancer patients in Europe surviving for at least 10 years. Ensuring this goal across Europe means reinforcing the development of a continuum of research activities, from basic to clinical research, including the reinforcement of the European network of Comprehensive Cancer Centres and the three research infrastructure components mentioned above, as well as active participation by the patients and their associations in order to mitigate social and economic inequalities.

The Porto Declaration on Cancer Research thus calls on all European citizens and their Member States to stimulate the synergies in the areas of regional, national and European funding so that cancer research infrastructure access will be easier and fairer.

Speaking at the Cancer Research Summit on 3 May, Health Commissioner Stella Kyriakides said that it’s key the Commission’s Cancer Plan “works hand in hand” with the Horizon Europe Mission on Cancer in order to “ensure coherence between research goals and policy objectives.”  screening program was suspended five years ago due to low turnout and needs to be upgraded, she explained. 

Consultation on health data sharing plan opened by Commission

On 3 May, the Commission 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.″

Innovative solutions and digital technologies including artificial intelligence (AI), can transform healthcare systems. They make them more sustainable and improve people's health. The development of these technologies requires secure access by researchers and innovators to substantial amounts of health data.

This public consultation focuses on:

the access to and use of health data for healthcare provision, research and innovation, policy-making and regulatory decision;

fostering a genuine single market for digital health services and products, including innovative ones.

The creation of a European Health Data Space is one the key priorities of this Commission in the area of health. The purpose of the EHDS is to promote health-data exchange and support research on new preventive strategies, as well as on treatments, medicines, medical devices and outcomes. In the Communication on the European Strategy for Data, the Commission announced its objective to deliver concrete results in the area of health data and to understand the potential generated by developments in digital technologies. The collection, access, storage, use and re-use of data in healthcare present specific challenges that need to be addressed.

This requires a regulatory framework that best serves individuals' interests and rights, especially as regards the processing of sensitive personal health data. In this context, the Commission adopted its Data Governance Act proposal (2020) with conditions regarding access to data, and provisions to foster trust in voluntary data sharing. Facilitating better access to, and exchange of, health data is essential to ensure increased accessibility, availability and affordability of healthcare. It will stimulate innovation in health and care for better treatment and outcomes, and encourage innovative solutions that make use of digital technologies, including AI.

Health commissioner offers sweeping ambitions for pharma reform and health committee publishes draft response to pharma strategy

No patient in Europe should have to go without medicines that he or she needs due to money or other obstacles, Health Commissioner Stella Kyriakides has said. 

Speaking at an event organized by the European Commission and the Portuguese EU presidency, Kyriakides pledged that EU’s pharmaceutical strategy will tackle the core issues that make medicines unavailable to those who need them. 

The strategy will culminate with a legislative proposal, planned for 2022, revising the EU’s basic pharma rules, which will open the door to the overhaul. 

Kyriakides’ willingness to tear up the current rules may make drugmakers nervous, since they rely on perks like market exclusivity to protect their bottom line. The 2022 reform will take into account “the relationship with intellectual property rights to address aspects that impede the competitive functioning of markets,” she noted. “The failures of markets should not be the failures of our health systems.”

The European Parliament’s Committee on the Environment, Public Health and Food Safety has published a draft response to the Commission’s Pharmaceutical Strategy. The draft report is authored by Spanish MEP Dolors Montserrat from the European People’s Party who is rapporteur for the pharmaceutical strategy. The document calls on the Commission to push ahead with a number of priorities that it identified in the pharmaceutical strategy, which it published in November. Among the demands made in the draft is a call on the Commission “to incorporate new criteria into the system of incentives for research into and the development of new medicines for unmet therapeutic needs.” It also asks the Commission to review incentives and improve price transparency.

EU pharma vulnerabilities

The executive arm of the European Union on Wednesday (5 May) moved to reduce the bloc's dependence on foreign supplies of products in key fields such as pharmaceuticals and digital technology. The initiative forms part of an updated industrial strategy aimed at strengthening the EU's single market, and was presented alongside a proposal for new regulations to tackle distortions caused by foreign subsidies in the bloc.

The European Commission's new industrial strategy is an update from one made in March 2020, before the World Health Organization declared COVID-19 a pandemic. Coronavirus has wreaked havoc in the 27-member EU, making itaware that over-reliance on imports for key components such as those required in drug production and semiconductors could disrupt entire sectors.

"We are updating our industrial strategy, applying the knowledge we have accumulated during the pandemic, drawing on lessons learned and the available evidence," European Commission Executive Vice President Valdis Dombrovskis told a news conference on Wednesday. He said that three key factors have influenced the thinking on the new strategy. The pandemic has highlighted some fragilities in the single market when exposed to particular types of disruption. There has been a growing trend in many jurisdictions to analyze vulnerabilities in key strategic value chains. And the business case for the EU's green and digital transition has become even stronger, Dombrovskis said.

Europe depends on third countries, primarily China and India, in its pharmaceutical supply chains, according to a Commission staff working document.

WHO’s emergencies programme ‘can't deal with multiple crises’

The coronavirus pandemic has revealed that the World Health Organization’s health emergencies programme is “inadequately equipped to deal with a global pandemic while simultaneously responding to other emergencies”, with chronic under-funding and under-staffing leaving it overstretched in some areas, a new report has found.

The report, penned by the Independent Oversight and Advisory Committee for the WHO’s health emergencies programme, covers May 2020 to April 2021 and will be presented at the World Health Assembly later this month. The committee is chaired by Felicity Harvey, a visiting professor at Imperial College London’s Institute of Global Health Innovation.

The programme had to leverage the entire organization during the pandemic and strengthen partnerships with member countries and expert groups to overcome those challenges, the panel found.

The report made specific mention of the Access to COVID-19 Tools Accelerator, of which COVAX is part of, noting that it has “struggled with shortfalls of political will and global solidarity, limited production capacity of vaccines and insufficient financial investment.”

Digital Green Certificate

The EU’s so-called COVID passport – the Digital Green Certificate – to travel freely during the pandemic should be ready for use from the end of June, according to Justice Commissioner Didier Reynders. At the Committee on Civil Liberties, Justice and Home Affairs (LIBE) of the European Parliament on Tuesday (4 May), Reynders said that the certificate will be in use before the summer. “We want to ensure that all EU citizens receive the same treatment when member states lift restrictions on free movement for holders of vaccines, recovery or test certificates,” he said. Last month, the European Commission presented its proposal for the certificate, which will provide proof that a person has been vaccinated against COVID-19, has natural immunity from it, or has a recent negative test result.

On 26 March, the European Parliament launched an accelerated procedure to fast-track the certificate’s approval, and the Parliament and the Member States are currently negotiating the practical details. In principle, however, the individual member states decide which consequences are attached to the document. These could include, for example, free access to the territory without mandatory quarantine.

And that is all from EAPM for this week – stay safe, stay well, have an excellent weekend, and see you next week.

Continue Reading

Cancer

EAPM: Fears of new waves raised as lockdowns ease

Published

on

Good morning, health colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update – with lockdowns easing across Europe, but fears of second or even third waves being raised globally, there is much to discuss in the health arena, writes EAPM Executive Director Denis Horgan.

COVID-19 in India

In India, a second COVID wave is wreaking havoc. Data suggests that this wave is proving to be more infectious and deadlier in some states, although India's death rate from the virus is still relatively low. But the county's healthcare system is crumbling amid the surge in cases - doctors say it's hard for them to "see the light at the end of the tunnel this time". Sharp rise in cases The rise in case numbers has been exponential in the second wave. On 18 June last year, India recorded 11,000 cases and in the next 60 days, it added 35,000 new cases on average every day. On 10 February, at the start of the second wave, India confirmed 11,000 cases - and in the next 50 days, the daily average was around 22,000 cases. But in the following 10 days, cases rose sharply with the daily average reaching 89,800. Chart showing cases in first and second wave Presentational white space Experts say this rapid increase shows that the second wave is spreading much faster across the country. Dr A Fathahudeen, who is part of Kerala state's Covid taskforce, said the rise was not entirely unexpected given that India let its guard down when daily infections in January fell to fewer than 20,000 from a peak of over 90,000 in September.

UK coronavirus: Boris Johnson warns of third wave

Pills taken at home to prevent severe Covid-19 infection could be available by the autumn, Boris Johnson said as he warned that a third wave of cases could hit the UK. The Prime Minister announced the creation of an “antivirals task force” charged with developing early-stage treatments for the disease. At a Downing Street press conference, he said that the UK’s “vaccination programme has demonstrated what the UK can achieve when we bring together our brightest minds”. It came as Mr Johnson acknowledged soaring cases overseas and warnings from scientists that there will be another wave this year. However, he said that he saw nothing that would cause the UK to "deviate" from its opening up schedule, and that we must "learn to live with the disease as we live with other diseases".

France launches digital health pass for air travel

France has launched an experimental digital health pass this week, becoming the first European country to allow air travel for those who have a negative coronavirus test or those who have recovered. The feature called notebook was introduced Monday (19 April) on the government’s TousAntiCovid app - allowing users to upload antigen or PCR tests by scanning a QR code on the test result form. A negative test result can be used for limited air travel to Corsica on Air France and Air Corsica flights and to overseas territories beginning at the end of May. Authorities are discussing the possibility of allowing the app to be used for entries to mass public events like music concerts, festivals, trade shows, but have ruled out its use for entry to "bars or restaurants," according to a report in Le Monde. “This system is more secure as there is no scope for fake paper certificates. It’s simple and can be easily shown at the airport,” Minister of State for Digital and Telecommunications Cedric O told France 3 news.

Commission probes biotech 'killer acquisition' thanks to new rule guidance

The European Commission has used new guidance on a key merger rule against so-called “killer acquisitions” to look into biotech company Illumina’s $7 billion deal to acquire cancer-test startup Grail. The takeover fell below the thresholds which normally trigger a merger investigation at the EU level. But Brussels was able to launch a probe at the request of France — subsequently joined by Belgium, Greece, Iceland, the Netherlands, and Norway — given the potential impact of the takeover on the market for cancer detection tests, the Commission said in a statement. The referral was possible thanks to new guidance from Brussels on a provision in EU merger rules, Article 22. According to the new reading, published on March 26, national regulators can ask Brussels to vet potentially harmful mergers that fall below the regulatory thresholds for a review. “A referral of this transaction is appropriate because Grail’s competitive significance is not reflected in its turnover,” the Commission explained. France’s competition authority, which first referred the deal to Brussels, took pride of having been the first to trigger the new tool. “This development has been called for by the authority for several years,” the French watchdog said in a statement.

The catch in Europe's 'green certificates' plan: COVID testing costs

New measures to allow Europeans to travel more easily this summer come with a hidden cost, say MEPs, who warn that the high-price tag of necessary coronavirus tests infringes on unvaccinated people’s right to free movement. The European Commission’s proposal for a so-called “digital green certificate” is intended to allow Europeans to move around more easily and safely despite the pandemic, and give a boost to the travel industry and tourism-reliant countries. The certificate, which will be issued free of charge, will indicate whether a person has been vaccinated, tested negative or recovered from the coronavirus. In theory, this ensures that unvaccinated people are not discriminated against. But coronavirus tests are expensive. That — in addition to quarantine measures demanded by some countries — creates an additional barrier to travel for unvaccinated people, said Dutch MEP Sophie in ‘t Veld.

Europe’s slow vaccine rollout means that most European adults are still waiting to receive their jabs, while high rates of vaccine skepticism in some countries suggest many may opt not to get vaccinated at all. “Many people can’t, or don’t want to, get a jab,” in ‘t Veld said in an interview. “Such a green certificate on the basis of a test must be a real alternative.” For that to be the case, tests have to be within reach for everyone, “and currently that’s simply not the case,” she added. The price for a PCR test varies wildly across Europe: France and Denmark offer tests free of charge, while a test costs 19,500 forints (€54) in Hungary and 520 złoty (€115) at Warsaw’s Chopin Airport.

According to data from travel association ABTA, Belgians are charged between €47 and €135, while Italians pay €63 on average and Portugal charges €75. It’s money travelers must be able to cough up several times, as countries often require two tests upon arrival, sometimes on top of a pre-departure test. In the Netherlands, tests cost between €70 and €140 — an “insurmountable obstacle” for many, especially for larger families or people who regularly commute across borders, such as truckers, according to in ‘t Veld. A divorced father who wants to visit his child in another country reached out to her, she said, because he couldn’t afford the tests. The difference in prices between countries also goes against EU treaties, which dictate that citizens should not be discriminated against on the basis of their nationality and that the single market should be free of disproportionate obstacles, in ‘t Veld said. The Dutch lawmaker, a member of the liberal Renew Europe group in the Parliament, has called on the Commission to put forward an emergency legislative proposal to cap the price of testing and suggested that EU citizens should have access to a number of free tests to allow them “to travel at least once during the holiday period”.

In ‘t Veld is not alone in seeing an issue with expensive testing. Greens MEP Tineke Strik said earlier this week that her group would put forward amendments to the green certificate proposal to ensure testing is free of charge. The Parliament is expected to nail down its position on the green certificates later this month, and in ‘t Veld is hoping to drum up support for a separate resolution — calling for Commission action on test prices — to be adopted at the same time. So far, the Commission’s response has been lukewarm. Making tests free of charge or capping their price “would constitute a serious interference in member states’ competence in the field of public health,” Commissioner for Justice Didier Reynders said Tuesday at a hearing of the Parliament’s industry committee. Such a proposal “would have to be carefully analyzed for its legality and feasibility,” he added. In ‘t Veld argues there’s “more than enough” of a legal basis for the Commission to step in, as the price of tests constitutes a “very clear obstacle to free movement” in the EU and the single market. She pointed at similar interventions to regulate credit card fees and bank transfer costs. “It’s as if this Commission is the lapdog of the member countries. They don’t dare to do anything without getting the green light from countries first,” she said.

Brexit to hit supplies of cancer, epilepsy and diabetes medicines to Northern Ireland, government warned

Brexit will prevent vital medicines to treat cancer, epilepsy and diabetes from reaching Northern Ireland, drug experts are warning. Firms making non-branded drugs are already starting to withdraw them because of costly new red tape, ministers are being told – threatening to cut the treatments available. The British Generic Manufacturers Association said planned new products being pulled before the rule changes come in next January included “treatments for epilepsy diabetes, and cancer”. “We need an urgent solution today,” said Mark Samuels, the trade body’s chief executive, adding: “If we don’t have a solution immediately, they will feel it in January.”

The threat has blown up because, at the end of a 12-month ‘grace period’, medicines made in Great Britain will require separate licences for use in Northern Ireland, as well as different safety inspections and other checks. The barrier is the latest to be put in the spotlight by the Northern Ireland Protocol, the 2019 treaty signed by Boris Johnson which has created a trade border in the Irish Sea. The new red tape emptied supermarket shelves in January, leading to the UK unilaterally shelving further checks – and a legal action launched by Brussels.

Johnson & Johnson to resume deliveries of COVID-19 vaccine to EU

Pharmaceutical company Johnson & Johnson is to resume deliveries of its one-shot COVID-19 vaccine to the European Union after the European Medicines Agency (EMA) confirmed its benefits outweighed the risks of blood clots as a very rare side effect. The vaccine leaflet is to be updated to include information on the diagnosis and treatment after the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) reviewed eight reported cases of unusual blood clots combined with low platelets among over seven million people who received the jab in the United States. It is likely to be several days before the National Immunisation Advisory Committee (Niac) will issue advice on the use of the Johnson & Johnson vaccine and the potential for spacing out between doses. Addressing an Oireachtas committee after the EMA announcement, Niac chairwoman Prof Karina Butler said it was awaiting further data from the European agency which may impact decisions on restricting access to specific age groups for some vaccines, and from the UK on dose intervals. This would be studied, along with projections on supplies of other vaccines and the potential impact of any decision on the wider programme, before recommendations were made to Government. On Monday (19 April), the National Public Health Emergency Team said it would not change its advice on extending the interval between doses of the Pfizer and Moderna vaccines until there was clarity on the Johnson & Johnson shot. Asked about the matter on Tuesday (20 April), Prof Butler said spacing out shots allowed to get “some vaccine into more people”, but that it could also favour the emergence of variants, and had to be balanced as it “will necessarily lengthen the time to get everybody fully vaccinated”.

And that is everything for now from EAPM – thank you for your company, stay safe and well, see you soon.

Continue Reading
Advertisement

Twitter

Facebook

Advertisement

Trending