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4 March 2014Big Pharma

Life Sciences Law Forum: disclosure of clinical data a key concern

A key concern for lawyers and in-house counsels practising in the pharmaceutical industry is the disclosure of clinical data, according to the co-chairs of DLA Piper's Global Life Sciences sector, Bonella Ramsay and John Dougherty.

Speaking at Practical Law's 2nd Annual Life Sciences Law Forum, they said the issue had been brought to public attention by Ben Goldacre's 2012 book Bad Pharma, and that the European Medicines Agency will publish its policy on the disclosure of clinical data later this month.

However, Ramsay wondered whether the resources to deal with such disclosure is available, and said that as the information is disclosed at a global level, a national approach to regulating it “just won't wash”. We must “take a global, joined-up approach”, she said.

Moreover, considering the volume of IP in the new wave of clinical data and who would want to use the information – doctors, patients and rival pharmaceutical companies – Dougherty said that while in theory it will advance medicine, whether the new transparency will restore trust is another question.

Dougherty and Ramsay identified trust as the second key challenge for 2014 alongside transparency. A number of bodies in the US and Europe have signed in, or are due to sign in, codes on transparency and disclosure this year, they said.

For example, the US Toolkit for Physician Financial Transparency Reports or “Sunshine Act”, which will require manufacturers of drugs, medical devices and biologicals that participate in US federal health care programmes to report any payments or items of value that are given to physicians and teaching hospitals, is due to come into force in September 2014.

The European Federation of Pharmaceutical Industries and Associations' equivalent code on disclosure was adopted last year.

However, a survey of in-house counsels on the most pressing legal issues in the life sciences industry revealed that the top issue of all for them was compliance, Ramsay and Dougherty said. It was followed by technology transfer, with patents and government investigations in joint third position.

Asked about the key issues that will change the sector in the next three to five years, the counsels ranked market access first, the trend towards transparency second and personalised medicine third, with biosimilars and social media also appearing within the responses.

Compliance and government investigations are the key areas “keeping general counsels up at night”, Dougherty said.

As for the future, Ramsay said that after a period of consolidation, more convergence is likely, especially with the emergence of personalised medicine, where business and regulatory models do not yet exist.

“We'll be bringing drugs out with a diagnostic,” she said, where patients can monitor their condition using converged technologies. How do royalty models fit when you have that kind of convergence?  As these are converged issues, lawyers should converge their practices, she said.

Practical Law's 2nd Annual Life Sciences Law Forum runs in London from March 4 to 5.

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