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12th April 2019
10th April 2019
Shortages of essential cancer medicines have a direct impact on patient care across Europe.
To ensure that this issue remains a top priority on the EU policy agenda, ESMO collaborated with the European Parliament to organise a cross-partisan event entitled “Shortages of Inexpensive, Essential Medicines: Calling for Tangible Political Commitments in the EU”.1
Shortages of inexpensive essential medicines have complex and multifactorial causes. In Europe, these often involve quality and manufacturing issues, including low profitability of inexpensive medicines and poor reporting mechanisms. In oncology, in particular, where there are often no alternatives to these medicines, shortages pose a threat to patient safety as they reduce adherence to therapy and limit the ability of physicians to provide effective treatment regimens.
Recognising that this issue cannot be addressed by any single country on its own, ESMO organised the meeting in Brussels to bring together Europe’s prominent stakeholders on the topic and drive concerted and collaborative action at EU level.
Vlad Voiculescu, Chair of the ESMO Patient Advocates Working Group as well as former Minister of Health of Romania, delivered the keynote speech at the event. A statement from the European Commission and a discussion with Member State representatives followed, with questions from the audience and an outlook on the next parliamentary legislature to conclude the working session. The meeting served also to launch a call to action1 with recommendations for the 2019-2024 legislative cycle.
Recommendations
ESMO President Josep Tabernero commented: “Shortages negatively impact both the health of European citizens and the sustainability of the healthcare systems. The situation is dramatically impacting on cancer patients, as the medicines affected by shortages have few proven effective alternatives or no alternative at all. That’s why ESMO is proposing a course of action with key steps to be taken in the near future.”
Among other measures, ESMO recommends that a common European definition of medicine shortages be created and that EU-level strategic plans and actions be introduced to respond to such shortages. The Society will also advocate that, as a first important step, an EU-wide study be developed on the issue and its overarching impact on the European Union.
“This is a public health emergency,” Tabernero emphasised. “The European Union has the competence to address market failures in this area, and ESMO can be a strong partner in developing practical solutions to prevent shortages going forward. I am confident that the discussions in Brussels will help to position inexpensive essential medicines as a key political priority for the EU legislature of the next five years.”
Reference
Healthcare professionals who qualified in the European Union (EU) can continue to practise in the UK after Brexit, even in a no-deal scenario, the Government has confirmed.
Legislation introduced by the Department of Health and Social Care (DHSC) last month (7 March) will allow healthcare professionals to continue to practise in the UK as they do now. It encouraged EU nationals working in the UK to apply for the EU Settlement Scheme.
All regulatory bodies for the health and social care sectors will accept the training EU nationals completed in their home countries, the DHSC said.
Those qualified in the European Economic Area (EEA) and Switzerland can register after Brexit takes place, even if the UK leaves without a deal, it added.
Employers will not need to change EU staff contracts even if the UK leaves without a deal, the DHSC said.
Health and social care secretary Matt Hancock said: ‘Every day across the health and social care system, our EU colleagues and friends make a difference to millions of lives, and this vital legislation means they will be able to continue work here, whatever the Brexit outcome.
‘My message to EU staff is clear – we all want you to feel valued and stay in the UK. Today’s announcement builds on our NHS long-term plan’s commitment to recruit and retain a world-class workforce over the long term.’
In a letter sent to health and social care staff last week (4 April), Mr Hancock reiterated the Government’s advice that pharmacies and patients should not stockpile medicines in anticipation of Brexit, although it is continuing to ask pharmaceutical companies to do so.
Mr Hancock said: ‘We know your focus is on maintaining high standards of care and strongly urge you and your colleagues not to over-order or over-prescribe medicines. Local stockpiling is unnecessary and could cause shortages which would put those that need medicines at risk.
‘We have well established routine procedures to deal with medicine shortages, from whatever cause…While we never provide guarantees, we are confident that, if everyone – including suppliers, freight companies, international partners and the health and care system – does what they need to do, the supply of medicines and medical products should be uninterrupted in the event of exiting the EU without a deal.’
This month, it emerged that 64% of primary care professionals predict that Brexit will make medicines shortages worse, according to the results of a survey by Hospital Pharmacy Europe’s parent company Cogora.
Stepping up efforts to prevent transmission of hepatitis C among people who inject drugs, could reduce future infections by 43% globally, according to a study by researchers at the University of Bristol published in the Lancet Gastroenterology and Hepatology.1
Hepatitis C is a virus that is passed on through blood exposure and results in liver disease. It is estimated that over 70 million people are infected with the hepatitis C virus worldwide and that around 400,00 people with hepatitis C die each year due to related conditions such as cirrhosis of the liver and liver cancer.
People who inject drugs are at high risk of becoming infected with the virus through the sharing of needles, syringes and other injecting drug equipment. While the percentage of people with hepatitis C is estimated to be less than one per cent in most countries, the percentage of people who inject drugs with hepatitis C tends to be over 30%.
The researchers used mathematical modelling to estimate how much the sharing of equipment for injecting drug use contributes to the hepatitis C epidemics for 88 countries, which account for 85% of the world’s population.
They estimated that, if hepatitis C transmission due to the risk associated with injecting drug use was removed, around 43% of all infections up to 2030 would be prevented globally.
Seventy-nine per cent of hepatitis C infections could be prevented in high-income countries and 38 per cent of infections in low- and middle-income countries. These estimates range from two per cent in Nigeria to 100% in several countries, including Iceland and Finland, with estimates of 98 per cent for the UK and 77% for the USA – rising to 85% when assuming an increasing epidemic of injecting.
Before blood screening was introduced in the early 1990s, contaminated blood transfusions were thought to be the main route of hepatitis C transmission. However, this is no longer the case in many countries, particularly high-income settings such as the UK and the USA. Hepatitis C is also transmitted through the re-use of unsterilised medical equipment, which is much more common in many low- and middle-income countries.
In the last decade new direct acting antiviral treatments for hepatitis C have become available, which cure nearly all individuals with hepatitis C infections. Subsequently, the World Health Organization has set targets to eliminate hepatitis as a public health problem by 2030.
Adam Trickey, from the NIHR Health Protection Research Unit in Evaluation of Interventions at the University of Bristol and lead author of the study, said: “As blood screening has improved, and there is less use of unsterilised medical equipment, a higher proportion of hepatitis C infections occur among people who inject drugs through the sharing of drug injecting equipment. This research highlights the importance of combating the hepatitis C epidemic among people who inject drugs, especially for meeting the World Health Organization’s 2030 elimination targets.”
Professor Peter Vickerman, from the NIHR Health Protection Research Unit in Evaluation of Interventions at the University of Bristol, who co-led the study, said: “Interventions already exist to reduce the transmission of hepatitis C among people who inject drugs, including methadone maintenance treatment, the provision of clean needles and syringes, and treating hepatitis C infections with direct acting antivirals. However, in most countries, these interventions are not widely used. Without significantly reducing hepatitis C virus transmission among people who inject drugs the World Health Organization’s elimination targets cannot be met.”
Reference
European health insurance cards (EHIC) may no longer be valid in the event of a no-deal Brexit, the Department of Health and Social Care has said.
Depending on arrangements made with EU member states and European Free Trade Area states (which includes Norway, Iceland, Liechtenstein and Switzerland), UK-issued EHIC cards may not be valid if a no-deal scenario goes ahead.
The DHSC updated its healthcare advice last month for UK travellers, stating that the Government is working to maintain the current healthcare arrangements in a deal or no-deal scenario until 31 December 2020.
This means that the Government will continue to cover healthcare for current or former UK residents who are visiting, living or working in the EU, but this depends on EU member states agreeing to extend the current arrangements until the end of 2020.
However, the NHS website has stated that if on April 12, the UK leaves the EU without a deal, then UK citizens visiting within the EU, the European Economic Area (EEA), and Switzerland will have to buy travel insurance to cover healthcare.
The NHS has published guidance for accessing healthcare in each EEA country, depending on the chosen country’s health system.
A spokesperson for the DHSC said: “The Department of Health and Social Care has been working closely with EU member states and EFTA states to protect existing healthcare arrangements for these and other groups.
“As we have always advised – UK nationals traveling abroad anywhere should always get compressive travel insurance, regardless of EU Exit or not.
“All UK nationals who are planning to reside in, travel to, work or study in the EU or European Free Trade Area (EFTA) states (Iceland, Norway, Liechtenstein and Switzerland) are strongly advised to check the country-specific guidance on GOV.UK and NHS.UK about healthcare arrangements if the UK leaves the EU without a deal.”
This story was first published by our sister publication Pulse.
The European Commission has approved Lynparza (olaparib) as a monotherapy for the treatment of adult patients with germline BRCA1/2-mutations (gBRCAm), and who have human epidermal growth factor receptor 2 (HER2)-negative locally-advanced or metastatic breast cancer.
Under the licensed indication, patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless they were unsuitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.
Dave Fredrickson, Executive Vice President, Oncology, said: “With this approval, Lynparza provides patients throughout the EU with a targeted and oral chemotherapy-free treatment option for a difficult-to-treat cancer. It also reinforces the importance of testing for biomarkers including BRCA, hormone receptor and HER2 expression, helping physicians to make the most informed treatment decisions for patients.”
Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: “In the OlympiAD trial, which supported this approval, Lynparza demonstrated a meaningful improvement in progression-free survival compared to chemotherapy in patients with germline BRCA-mutated metastatic breast cancer. We look forward to making this new option available across the EU, where we hope it will improve outcomes for many patients.”
The approval was based on data from the randomised, open-label, Phase III OlympiAD trial which tested Lynparza vs. physician’s choice of chemotherapy (capecitabine, eribulin, or vinorelbine). In the trial, Lynparza provided patients with a statistically-significant median progression-free survival improvement of 2.8 months (7.0 months for Lynparza vs. 4.2 months for chemotherapy). Patients taking Lynparza experienced an objective response rate (ORR) of 52%, which was double the ORR for those in the chemotherapy arm (23%).
This is the third indication for Lynparza in the EU, and AstraZeneca and MSD are working together to deliver Lynparza as quickly as possible to more patients across multiple settings. Lynparza has a broad clinical development programme, including the ongoing Phase III OlympiA which is testing Lynparza as an adjuvant treatment in patients with gBRCAm HER2-negative breast cancer.
9th April 2019
NHS England has said it is going to “formally request” that the Government bans GPs from prescribing homeopathy.
In 2017, NHS England published guidance to stop prescriptions for 18 low clinical priority treatments including homeopathy given the lack of “clear or robust evidence”.
In addition to existing guidelines, NHS England has now said it will ‘formally’ request that the Department of Heath and Social Care (DHSC) blacklists homeopathy to make sure available funding is better used.
If the DHSC goes along with NHS England’s recommendation, then homeopathy would no longer legally be prescribed in primary care settings.
An NHS England spokesperson said: “The NHS has issued guidance making it clear to GPs that homeopathy should not be prescribed, and to give further legal force to this we will now be formally requesting that the DHSC blacklists it so that funds cannot be wasted in this way.”
A DHSC spokesperson said: “We expect GPs to prescribe treatments for the clinical benefit of their patients. In line with the clinical evidence on the effectiveness of homeopathy, NHS England issued guidance to prescribers on the use of various items of low clinical value, which has resulted in a decline of homeopathic prescribing in primary care of 52%.
“We will consider NHS England’s request and respond in due course but we would expect doctors to be following these guidelines already.”
There is already a blacklist of drugs that GPs may not prescribe, which appears under Schedule 1 of the 2004 GMS contract.
The list, which includes drugs that experts agreed had no clinical or therapeutic advantage over other cheaper drugs, was first set up in 1985 and no new items have been added since 2004.
Last year, the High Court rejected a legal challenge brought in by the British Homeopathic Association to overturn NHS England plans to no longer routinely fund homeopathy.
NHS England welcomed the court victory, with chief executive Simon Stevens calling the legal challenge ‘costly and spurious’ and stating that homeopathy is a ‘misuse of scarce NHS funds’.
This came after research found that over 2,700 homeopathy prescriptions were issued by GP practices between December 2016 and May 2017, costing a total of £36,532.
Meanwhile, researchers revealed that GPs are writing one million fewer prescriptions for low-priority treatments but that price hikes have led to a rise in the overall spending.
This story was first published by our sister publication Pulse
8th April 2019
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