PharmExec Blog

60 Years of Pharma Regulation in Europe

European regulation of pharmaceuticals has, since the foundation of the European Union around 60 years ago, been a story of medicines being controlled in a collaboration between regulators at the EU and national levels.

In recent years, this collaboration has been extended to involve not just the regulators themselves but also other stakeholders such as large, medium and small pharmaceutical companies, prescribers and patients.

A major objective of the European pharmaceutical legislation, particularly at the EU level, has been to support the competiveness of the European pharmaceutical industry. This aim has become more urgent with the industry coming under pressure from globalization. \

In this special Pharmaceutical Technology Europe feature, Sean Milmo looks at the key events and controversies in European drug regulation over the last 60 years.

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Biosimilar Development in Europe: Ten Years On

The European Union established the first legal regulatory guidelines for biosimilars in 2005. The first biosimilar, Omnitrope, a version of somatropin, was approved in April 2006. To date, the EU has approved 19 applications in total (two were withdrawn after authorization so 17 are now marketed) and continues to update its guidelines, general and product-specific, in the light of its experience.  

In this special Pharmaceutical Technology Europe feature, Fiona Greer looks at what the future holds for biosimilars in Europe.

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Primary Care Diabetes Prescriptions Cost UK Over £2 Million a Day

Prescriptions to manage diabetes in primary care in the UK cost the NHS an average of £2.2 million ($3.7 m) every day in 2013-14, according to a report from the Health and Social Care Information Centre (HSCIC).

The report, Prescribing for Diabetes, also shows the Net Ingredient Cost (NIC)  for managing diabetes was £803.1 million ($1,347 m) in 2013–14. This is a 5.1 per cent increase from £764.1 million in 2012–13 (£2.1 million per day on average) and a 56.3 per cent increase on £2005-06 (£1.4 million per day on average). Read More »

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More Than Half of US Approved Drugs Developed by Collaborating Companies

According to the Tufts Center for the Study of Drug Development R&D Management Report, more than half of all new drugs approved in the US between 2000 and 2011 were developed by companies that collaborated in one form or another with other entities. The report is based on insights gathered at an executive roundtable of biopharma R&D leaders. Other points included that risk-sharing partnerships are most likely to succeed when governed by a charter that ensures executive engagement, clearly delineates roles and tasks for each organization and key individuals, and defines success metrics and quality measures

Read the full story here.

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Brown University’s Executive Masters in Healthcare Leadership: A Mission to Transform

Mid-career students at Brown University’s new Executive Masters in Healthcare Leadership program are challenging the status quo with workplace projects focused on one thing: removing the organizational silos that slow innovations in the delivery and financing of healthcare.

As the US healthcare system stumbles toward a new consensus built around the “triple aim” of increased access, improved quality, and lower cost, the push is on for new ideas that can test the boundaries of current practice. The Affordable Care Act (ACA) creates a range of incentives to promote this goal, which has added to the momentum around novel reform approaches. Business management schools have jumped with gusto into the fray, providing much of the intellectual heft for integrative, outcomes-oriented programs that stress patient wellness and require medicines to do more than just treat disease.

One institution, Brown University, has gone a step further than many of its counterparts, with a new 16-month Executive Master of Healthcare Leadership (EMHL) program dedicated to empowering mid-career health professionals with the diverse interests, skills and capabilities to challenge that status quo and “transform” healthcare as we now know it.

For more on this article, click on this month’s issue of Pharm Exec.

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