Archive for the 'Europe News' Category

Patients Wade into the European Pricing Debate

An important third party is struggling to make its voice heard in European pharma discussions. Drug pricing is not just a matter of manufacturers battling with health ministries, insist groups representing the end-users of medicines — that is, the patients. Over and above the questions of costs and bureaucracy, the more important issues of equity and patients’ rights are at stake. And these, according to patient groups, are critically threatened by delays in access to treatment. Read more »

Cooperation in Global Regulation Sees Benefits

The European Medicines Agency announced on July 30, 2012, that its efforts to increase interaction and cooperation with regulatory authorities in Japan have paid off. In 2007, confidentiality agreements between the EU and Japan were established for a five-year period to allow for an exchange of information to enhance regulatory and scientific processes. According to EMA, the areas of orphan drugs, pediatrics, advanced therapies, pharmacogenomics, and nanomedicines have especially benefited from the collaboration. Read more »

UK Examines Earlier Access to Medicines

Stephanie Sutton Pharm Tech EuropeLast week, I looked at a consultation in the UK concerning access to unlicensed medicines. The 12-week consultation, launched by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), seeks opinions on giving physicians the option to prescribe seriously ill patients certain medicines that are still progressing through Phase II and Phase III clinical trials. The blog is available here.

The scheme forms a key part of the UK government’s Strategy for UK Life Sciences, which aims to support innovation and give the UK a leading role in life sciences globally. Included in this is a provision to provide patients with better access to innovative medicines. Read more »

UK Mulls Access to Unlicensed Medicines

Stephanie Sutton Pharm Tech EuropeThe UK’s Medicines and Healthcare products Regulatory Agency (MHRA) recently launched a 12-week public consultation for a national scheme that will look at the possibility of providing seriously ill patients with access to unlicensed medicines still in Phase III, or possibly even Phase II, clinical trials. Similar initiatives, mainly through extensions of clinical trials or managed-access programmes, are already in place in certain parts of the UK, as well as in the US and other countries, but these are often ad-hoc in nature and locally based. The proposed scheme would provide a national approach to providing early access to certain medicines in the UK.

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GSK’s Olympic Role

Stephanie Sutton Pharm Tech EuropeThere are many ways in which pharmaceutical companies can make a contribution to society beyond developing and manufacturing medicines. GlaxoSmithKline, based in the UK, has always been keen to position itself as a supporter of the British economy so it’s no surprise to see the pharma giant being patriotic once again as it touts its involvement in the Olympic Games, which will start in London in just under two-weeks time. Read more »

Pricing Controversy in Germany

Stephanie Sutton Pharm Tech EuropeGermany used to be a golden market for the pharma industry in Europe because the country allowed global pharmaceutical companies to set their own prices for new medicines. However, all good things must come to an end…

In Germany, healthcare reform (known as AMNOG – Arzneimittelmarkt-Neuordnungsgesetz) that came into effect in January 2011 introduced stringent new pricing measures that linked the price of a medicine to its perceived therapeutic benefit. Eighteen months from the reform and the full effects have been realised. Although successful in cutting costs (a primary goal of the legislation), the change has resulted in a number of global companies delaying or refusing to market their drugs in Germany. It’s a testament to the fact that Germany has historically been one of the first markets in Europe to receive innovative new drugs. Read more »

Bayer Force One

Efficient energy consumption has taken to the friendly skies with a little help from the sun—and pharma. The Solar Impulse, a Swiss solar-powered airplane, is attempting to make its longest flight—from Switzerland to Morocco with a layover in Spain—in a 48-hour intercontinental test flight piloted by project originators Bertrand Piccard and André Borschberg.

Bayer MaterialScience became an official partner of the project in 2010, according to a May 24, 2012, press release. Since then, more than two dozen scientists at the company’s laboratories in Leverkusen, Dormagen, and Krefeld-Uerdingen, Germany, have been tasked with brainstorming ideas for lightweight construction and energy efficiency.

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Parallel Trade Fuels UK Drug Shortages

Stephanie Sutton Pharm Tech EuropeA bill has recently been in discussion in the US that contains measures to strengthen the ways in which drug shortages are dealt with. The US FDA is also taking action by asking companies to alert them as to possible drug shortages so that it can prepare back ups. But what about other parts of the world?

Drug shortages are not unique to the US. The UK is also currently struggling with severe shortages of prescription medicines. In the US, many shortages have been attributed to plant closures or manufacturing problems, but in the UK the shortages are being caused for a different reason: parallel trade.

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EFPIA Moves Forward With Verification system

Stephanie Sutton Pharm Tech EuropeFor some time, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has been working on developing a European verification system to help combat falsified medicines. The system, the European Medicines Verification System (EMVS), now seems close to implementation as EFPIA has launched a tendering process to select potential vendors for the technology. Read more »

Vaccine Tied to Narcolepsy

Stephanie Sutton Pharm Tech EuropeThe 2009 swine flu pandemic (and panic) has been forgotten by most, but regulators, global health organisations and pharmaceutical companies are continuing post-pandemic activities, which include keeping an eye on new cases of the illness and monitoring the safety of pandemic vaccines.

This week, swine flu returned to headlines after two studies published in the Public Library of Science appeared to confirm a link between GlaxoSmithKline’s Pandemrix vaccine and cases of narcolepsy in children in Finland. Between 2002 and 2009, instances of narcolepsy were around 0.31 per 100,000 people. In 2010, this jumped to 5.3 cases per 100,000, which equates to a 17-fold increase. Read more »

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