On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
Health Secretary defies order to disclose advice on National Health Service reform risks
The Department of Health appealed against the decision of the Information Commissioner that it was obliged to disclose a transition risk register, arguing that the information was exempt from disclosure because it relates to the formulation or development of government policy (s.35(1)(a) FOIA 2000). On hearing the appeal, the Tribunal reiterated that s.35(1)(a) was a qualified exemption subject to a public interest test. It had a broad construction, and the government was entitled to a "safe space" in order to consider policy options. However, the Tribunal held that the need for a "safe space" would change during the life of a Bill. For example, while the policy was being formulated, at a time of intensive consultation, the need for a "safe space" would be at its highest. Once the policy was announced, the need would diminish. However, while it was being debated in Parliament, (and therefore there could be need for the government to develop further policy), it should be possible for the government to dip in and out of the "safe space" to allow options to be considered.
In this instance, the Tribunal held that the request had been refused at a time when consultation had ceased and policy seemed to be fixed. Therefore the need for a "safe space" was lessened. Given the very high public interest in understanding the risks involved in such wide-ranging and politically controversial reforms to the NHS, it was held that at the time of the request, the public interest in maintaining the exemption did not outweigh the public interest in disclosure.
This restrictive approach to the exemption for information relating to the formulation government policy indicates significant weakness in an exemption that is frequently relied upon by the Government, and may present further opportunities for considerable political mischief. While transparency is to be welcomed, many have expressed fears that this decision could reduce the quality and frankness of policy advice given to ministers, and could discourage civil servants from putting that advice in writing. It will be interesting to see whether these concerns are borne out and whether Mr Lansley's decision to invoke the veto — used only four times since the Freedom of Information Act was passed in 2000 — will be followed by others in the face of future requests.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017