Posts Tagged “European Medicines Agency”

Primodos: Firms and govt face legal action over claims pregnancy drug ‘damaged babies’

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Primodos: Firms and govt face legal action over claims pregnancy drug ‘damaged babies’

Parents who say their babies were damaged by a pregnancy test drug have warned manufacturers and the government that they are preparing to take legal action. Lawyers representing more than 200 claimants have written letters accusing two drug companies and the UK regulators of being negligent and putting patients at risk. The drug Primodos was given to women in the 1960s and 70s. It was made up of two pills which would induce a period in women who were not pregnant. However, many families believe that if the mother was pregnant, it damaged or even killed their children in the womb. If successful the claim could be worth millions as the alleged victims all suffer with a variety of life-changing difficulties, including limb malformations, musculoskeletal abnormalities, heart defects and brain injuries. Some parents are also claiming still births were caused by the drug.

The proposed legal action follows a Sky News investigation in 2017 where we found documents in German archives showing manufacturers were warned by UK regulators that those using the drug had an increased risk of malformations – and that records from that study appeared to have been deliberately destroyed in order to frustrate any future legal action….

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Netherlands: Wemos’ project “Medicines That Matter” focuses on added therapeutic value

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Netherlands: Wemos’ project “Medicines That Matter” focuses on added therapeutic value

 

According to recent independent reviews, as many as 85-90% of new medicines provide little to no clinical advantage to patients. The result is enormous amounts of – often public – money being invested into delivering highly priced medicines of limited added therapeutic value (ATV), while the medicines that are truly needed are left out of development plans.

Confronting this challenge is Wemos, a Netherlands-based organisation committed to improving transparency around medicines pricing, promoting independent clinical research, and lobbying for medicines that meet unmet medical needs.

Health Europa spoke to global health advocate Ella Weggen to find out more about Wemos’ work.

What does Wemos believe is insufficient about the way new medicines are currently delivered onto the market?

We at Wemos believe that health is a human right and that access to adequate healthcare and to medicines is a part of that. We believe that the government has a responsibility to make sure that people get the medicines they need. But at present it appears that the government – certainly in the Netherlands but also in countries across the EU – doesn’t have control over the pricing of certain medicines, which means that a lot of new medicines are…

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Innovative approaches needed to overcome challenges with improving access to personalised medicines

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Innovative approaches needed to overcome challenges with improving access to personalised medicines

The new models that could help the industry encourage the adoption of personalised treatments

For health systems, personalised medicines can lead to decreased use of ineffective treatments, reduced hospitalisations and other costs associated with chronic conditions, and more efficient use of healthcare resources. But there are also a number of environmental and organisational challenges that currently prevent the effective uptake of personalised medicines and potentially hinder their development. A range of stakeholders including leading payers, policymakers and healthcare professionals have called for efforts to better understand these challenges to support target goals in patient access for new therapies while also maximising their positive impact on health systems in the UK and throughout the EU.

To better understand the factors that can affect access to personalised medicines, CRA recently completed an analysis (sponsored by EFPIA/EBE) focusing on new personalised immunotherapies and assessed the extent to which they are made available in the UK, Denmark, France, the Netherlands and Poland. These countries collectively represent a broad range in terms of geography, reimbursement mechanisms, approaches to health technology assessments (HTAs), treatment infrastructure and healthcare policies.

The analysis highlights a clear need for innovative strategies to address challenges and to prioritise personalised medicines within a…

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Lonely planet: why there is dwindling value in pharma travelling alone

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Lonely planet: why there is dwindling value in pharma travelling alone

Almost a decade ago, PwC predicted that by 2020, no pharmaceutical company would be able to ‘profit alone’. Success, it said, would require companies to join forces with other organisations and swim upstream into the health management space to preserve the value of its products.

Published in 2009, Pharma 2020: Challenging Business Models argued that pharma would need to collaborate with academic institutions, hospitals and technology companies, as well as providers of services such as nutrition, health screening, compliance and wellness to deliver meaningful value beyond medicine. With the 2020 milestone almost upon us, evidence suggests that the central prediction of the PwC report has proved to be correct. Pharma has recognised the need to change its traditional business model and explore more collaborative ways of working. But how far have we come? Close, but no cigar.

The rationale and drivers for change remain the same today as they were a decade ago. The cost of healthcare is soaring as populations age, with the growing burden of disease placing intolerable pressure on global health systems and economies. As governments explore new ways of finding efficiencies in the public purse, many are introducing value-based models that reimburse medicines based on the…

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Brexit uncertainty adds significant risk to EU medicines access

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Brexit uncertainty adds significant risk to EU medicines access

Next week, leaders of the 28 countries making up the European Union will meet in Brussels to try to hammer out the terms of Britain’s exit from the coalition, or Brexit. It will be one of the last chances to do so before the country departs on March 29, 2019.

Britain stunned the world in June 2016 when a slight but significant majority of voters elected to leave the EU. The decision has left many businesses, including pharmaceutical firms, rushing to prepare for the changes that Brexit will bring. “A vote to leave is the gamble of the century,” David Cameron, then British prime minister, wrote months ahead of the referendum. “And it would be our children’s futures on the table if we were to roll the dice.”

Belonging to the EU means being part of the single market, which allows people, goods, services, and money to move freely across member countries’ borders. The difficulty of disentangling these political and economic ties has led to more than a year and a half of messy negotiations, as politicians struggle to agree on how the future relationship between the UK and the EU should look. Options have ranged from what news media…

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Britain loses medicines contracts as EU body anticipates Brexit

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Britain loses medicines contracts as EU body anticipates Brexit

Britain’s leading role in evaluating new medicines for sale to patients across the EU has collapsed with no more work coming from Europe because of Brexit, it has emerged.

The decision by the European Medicines Agency to cut Britain out of its contracts seven months ahead of Brexit is a devastating blow to British pharmaceutical companies already reeling from the loss of the EMA’s HQ in London and with it 900 jobs.

All drugs sold in Europe have to go through a lengthy EMA authorisation process before use by health services, and the Medicines & Healthcare products Regulatory Agency (MHRA) in Britain has built up a leading role in this work, with 20-30% of all assessments in the EU.

The MHRA won just two contracts this year and the EMA said that that work was now off limits. “We couldn’t even allocate the work now for new drugs because the expert has to be available throughout the evaluation period and sometimes that can take a year,” said a spokeswoman.

In a devastating second blow, existing contracts with the MHRA are also being reallocated to bloc members.

Martin McKee, the professor of European health at the London School of Hygiene and…

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A third of EU’s drug regulator’s staff quit ahead of Brexit

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A third of EU’s drug regulator’s staff quit ahead of Brexit

London — About a third of employees at the EU’s drug regulator are expected to quit as it leaves Britain because of Brexit, prompting the agency to temporarily scale back operations to focus on essential public-health activities.

Staff who aren’t relocating to Amsterdam with the European Medicines Agency (EMA) have already started to leave, a trend that’s set to accelerate, the regulator said in a statement on Wednesday. The agency expects to lose almost a third of its staff, more than it anticipated, with 135 short-term contractors no longer able to work due to labour laws in the Netherlands.

The staff losses due to Brexit are disrupting work at the agency, which is the EU’s equivalent of the US Food and Drug Administration and oversees medication safety for about 500-million people. With a workforce of about 900, the EMA is making a major move at a time when it’s beginning to evaluate more complex products, such as therapies to correct gene defects.

Along with the staff loss of about 30%, the EMA warned of a “a high degree of uncertainty regarding mid-term staff retention”. The agency’s announcement confirms warnings that executive director Guido Rasi gave in a June interview with…

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Developments for the European Medicines Agency

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Developments for the European Medicines Agency

On Tuesday night, MPs in Westminster adopted an amendment to the Trade Bill which indicates support for the United Kingdom remaining in the regulatory framework of the European Medicines Agency (EMA)

Clause 17 of the Trade Bill was proposed by Phillip Lee MP and 305 MPs voted in favour to 301. Last month, Phillip Lee MP resigned from the government in response to how he felt Brexit was being handled.

The vote concerned remaining in the EMA and ensuring regulatory cooperation continues as part of the European medicines regulatory network. The EMA is an agency of the EU which ensures the protection of public and animal health in EU member states and countries which are in the European Economic Area (EEA).

The EMA has various responsibilities including enabling the development of and access to medicines in the EU and guaranteeing the safety of these medicines.

This amendment is a positive indication that the current pace of regulation will continue. We hope that this means that brain tumour patients will still be able to access new medicines which emerge. With fewer treatments available for rare diseases, it is essential that the UK remains collaborative with its EU partners in the search…

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Ministry recalls medicine in Dubai

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Ministry recalls medicine in Dubai

The Ministry of Health and Prevention, MOHAP, has issued a circular ordering the recall of some anti-hypertensive medicines containing the active ingredient, Valsartan, manufactured by Chinese company Zhejiang Huahai Pharmaceutical after the detection of impurities in the active ingredient.

“This recall is a precautionary measure taken by the ministry following the report issued by the European Medicines Agency indicating the detection of a contamination of the active ingredient with N-Nitrosodimethylamine, NDMA, a chemical that might lead to cancer. Valsartan is a medicine used for the treatment of hypertension to prevent related cardiovascular complications,” the ministry said in a statement.

According to the ministry, the circular was released and addressed to all directors of the medical districts, directors of public and private hospitals, doctors, pharmacists and assistant pharmacists, and directors of government and private pharmacies. The recall was issued after the ministry’s senior officials reviewed Ministerial Resolution No. 366 of 2010 governing the withdrawal, suspension, or prevention of distribution of pharmaceutical and medical products to protect public health.

The circular includes a list of affected products that have been registered with the drug department of MOHAP. The recall order was sent to authorised agents and distributors of the recalled products with…

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Hidden conflicts? Pharma payments to FDA advisers after drug approvals spark ethical concerns

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Hidden conflicts? Pharma payments to FDA advisers after drug approvals spark ethical concerns

On a sweltering July day in 2010, seven medical researchers and one patient advocate gathered in a plush Marriott hotel in College Park, Maryland, to review a promising drug designed to prevent heart attacks and strokes by limiting blood clotting. The panel is one of dozens of advisory committees that vote each year on whether the Food and Drug Administration (FDA) should approve a therapy for the U.S. market. That day, panel members heard presentations on the drug’s preclinical and clinical data from agency staff and AstraZeneca in Cambridge, U.K., its maker and one of the world’s largest pharmaceutical companies. The occasion sparked little drama. In the cool refuge of the conference room, advisers politely questioned company scientists and complimented their work. By day’s end, the panel voted seven to one to approve. FDA, as usual, later signed off. The drug, ticagrelor, marketed under the name Brilinta, sold rapidly, emerging as a billion-dollar blockbuster. It cuts risk of death from vascular causes, heart attacks, and strokes modestly more than its chief competitor—and currently costs 25 times as much.

FDA, headquartered in Silver Spring, Maryland, uses a well-established system to identify possible conflicts of interest before such advisory panels meet. Before…

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