The European Medicines Agency has announced a three-month public consultation on a draft policy on the publication and access to clinical-trial data. Comments should be made using the submission form and sent no later than 30 September 2013 to firstname.lastname@example.org.
The Agency has committed to the proactive publication of data from clinical trials submitted in support of a marketing-authorisation application, once the decision-making process has ended.
In its draft policy, the Agency has defined three categories of clinical-trial data corresponding to different levels of access.
- Category 1: ‘commercially confidential information’, including, for example, the details of theinvestigational medicinal product itself, some in vitro studies or bioanalytical data characterising the product.
- Category 2: ‘open access’, such as any clinical-trial data, information or documents that do not contain patients’ personal data. This information will be downloadable from the Agency’s website, at the time of publication of the European public assessment report (EPAR) for positive decisions, negative decisions or withdrawals.
- Category 3: ‘controlled access’, covering clinical-trial data, information or documents containing patients’ personal data. These include individual patient data sets, individual patient line-listings, individual case report forms, and documentation explaining the structure and content of data sets. Data will need to be adequately de-identified according to a recommended minimum standard. Further, access to these data will only be granted after the requester has fulfilled a number of requirements, including the signing of a data-sharing agreement.
The Agency expects the policy to come into force on 1 January 2014. However, its implementation will be impacted by the outcome of two other closely related events:
A decision by Europe’s drug regulator to release detailed data on drugs once a medicine is approved could discourage critical investment in crisis-hit Europe, Sanofi’s chief executive said to news agency Reuters.
Chris Viehbacher, who took over as president of the European Federation of Pharmaceutical Industries and Associations (Efpia) on Monday, said companies would invest in regions where they felt welcome.
“If you, on the other hand, say, ‘you guys are bad actors, we want to cut your prices, we want to take your confidential data and share it with any one of your competitors’, you don’t get the same feeling of encouragement,” he told reporters.
His comments coincide with publication of a draft policy from the European Medicines Agency (EMA) that would see the regulator proactively release detailed clinical trial data on newly approved drugs from 2014. The controversy over clinical data transparency compounds a situation where drugmakers are already reluctant to invest in Europe because of a wave of austerity-driven cuts in drug prices.
As an interesting contrast, David-Alexandre Gros, Chief Strategy Officer of Sanofi, said at an FT conference in December 2012 that “the pharmaceutical industry should have nothing to fear about publishing raw data from clinical trials”
The House of Commons Science & Technology Select Committee is currently taking its third session of oral evidence for its inquiry into clinical trials and transparency.
Previous sessions have demonstrated subtle differences in the positions of the main groups of stakeholders, particularly regarding what data it is feasible to release due to concerns around commercial confidentiality and informed consent that did not mention the possibility of data release. Another common theme has been that, whatever happens in the UK, it can only be effective if it is part of a broader (pan-European or, ideally, global) consensus on appropriate sharing of data.
Speaking at this session are:
- Professor Karol Sikora, Medical Director, Cancer Partners UK and Dean, University of Buckingham Medical School
- Simon Denegri, NIHR National Director for Public Participation and Engagement in Research and Chair, INVOLVE
- Tracey Brown, Managing Director, Sense About Science
- Dr Helen Jamison, Deputy Director, Science Media Centre
- Sir Kent Woods, Chief Executive, Medicines and Healthcare Products Regulatory Agency
- Dr Janet Wisely, Chief Executive, Health Research Authority
- Bill Davidson, Acting Deputy Director and Head of Research Standards and Support
- Peter Knight, Deputy Director, Head of Research Information and Intelligence, Department of Health
You can watch streaming video from the session, or watch the a recording of the whole session here. A transcript will be published in due course, and a summary of the most important points will be reported here on ClinDev.
The European Medicines Agency has halted disclosure of study documents relating to legal action currently being taken by AbbVie and Intermune, following interim rulings by the General Court of the EU. The EMA is considering whether to appeal the interim decisions and will continue with its policy to grant access to documents relating to other studies, considering requests on a case-by-case basis in the light of the Court Orders.
The companies are challenging the EMA’s decisions to grant access to non-clinical and clinical information (including clinical study reports) submitted by companies as part of marketing-authorisation applications in accordance with its 2010 access-to-documents policy. The EMA welcomes the opportunity for legal clarification of the concept of commercially confidential information.
Since November 2010, the Agency has released over 1.9 million pages in response to such requests. This is the first time that the policy has been legally challenged. Since the two pharmaceutical companies filed these legal actions, the EMA has received more than 30 statements of support from various stakeholders, including the European Ombudsman and national competent authorities.
The interim ruling has been welcomed by PhRMA but branded ” a disgrace” by Ben Goldacre, writing on AllTrials.net.
In an interview with BBC India Business Report, the head of Novartis in India, Ranjit Shahani, suggested that pharma R&D investment in India will cease following the Supreme Court decision not to grant the Swiss pharma company a patent for its oncology drug Glivec. He explained that Novartis was “disappointed” by the court’s decision, and stressed that 95% of Indian patients prescribed Glivec receive it free of charge.
In the context of the interview, it is not clear whether Mr Shahani’s comments are a formal statement of Novartis’ intent to stop all R&D in India immediately (there is no mention of this on the Novartis website), or a more general “sea change” in industry sentiment towards the country, with several big pharma companies losing out recent court cases around intellectual property.
Click here to watch the full interview on the BBC website.
The decision today by India’s Supreme Court to deny Novartis a patent for its cancer drug Glivec® (imatinib mesylate) has been welcomed by Indian patient activists and generics manufacturers. However, it causes concern for the Swiss pharma company, along with Pfizer, Bayer and Roche, who are currently challenging patent decisions in India for their drugs Sutent, Nexavar and Pegasys respectively. The implications for pharma investment in R&D in India will also be worrying for the growing India CRO sector.
The Supreme Court ruled that the patent application was an example of “evergreening” – making a small alteration to an existing drug in order to gain additional patent protection. The compound is based on a drug originally patented in 1993, and its patent in the USA was granted an extension to expire in 2015. Ranjit Shahani, Vice Chairman and Managing Director, Novartis India Limited, stated that “Novartis has never been granted an original patent for Glivec in India” and that the company “provides Glivec free of charge to 95% of patients prescribed the drug in India, currently more than 16,000 patients”.
The ruling also raises questions around global pharma’s willingness to invest in India, which has a massive population although many of them cannot afford conventional drug prices. Issues around protection of Intellectual Property have dogged India for many years, with pharma patenting only being introduced in 2005. Novartis has previously said it needs legal certainty if it is to plan further investment in drug research in India, and other companies will doubtless be considering this when distributing their global R&D investment.