On October 12, FDA published guidance for sponsors, investigators, and IRBs titled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” The guidance outlines FDA’s expectations for clinical research that is subject to both the FDA’s human subject protection regulations and DHHS’ recently revised Common Rule, which takes effect in January
Category Archives: Freedom of Information
Subscribe to Freedom of Information RSS FeedCMS proposes requiring drug prices in TV ads
On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer (DTC) advertisements for prescription drugs covered by Medicare or Medicaid to include the Wholesale Acquisition Cost (WAC). This proposed rule resembles a rejected Senate amendment to the FY-2019 Labor-HHS-Education appropriations bill (analyzed here) that would
Closing the stable door after another horse has bolted: The Information Rights Tribunal confirms the persuasiveness of other public authority decisions on disclosure of similar commercially confidential information
The First-tier Tribunal (Information Rights) (“FtT“) has published an interesting decision on the disclosure of commercially confidential information. In John Eustace v The Information Commissioner, Southampton City Council (the “Council“) was ordered to disclose commercial information relating to the revenue stream it received from bus stop advertising, in part because other local authorities had been
Open Government National Action Plan aims to increase transparency in government over the course of 2016-2018
Following a Conservative manifesto commitment in 2015 to increase transparency in government, the Cabinet Office has published the UK Open Government National Action Plan 2016-2018. This is the third National Action Plan (“NAP“) since the United Kingdom co-founded the Open Government Partnership in 2011, which now includes 69 countries. The new NAP makes 13 commitments
The Independent Commission on Freedom of Information issues call for evidence
The Independent Commission on Freedom of Information has recently issued a call for evidence as part of a review which may herald comprehensive changes to the Freedom of Information Act 2000 (“FOIA“). The Commission, established amid concerns that the current regime does not adequately protect sensitive information (see our previous blog post), will consider how
Cabinet Office Announces Commission to Review Freedom of Information Legislation
The Cabinet Office has recently announced that a cross-party commission is to look into the Freedom of Information Act 2000 (“FOIA”) in light of apparent concerns that sensitive information is not being sufficiently protected. FOIA was introduced under the last Labour Government, coming fully into force on 1 January 2005, and allows a private citizen
What will be the impact of the new EU Data Protection Regulation on the UK’s Freedom of Information Act?
The future of the s. 40 exemption Undoubtedly one of the more mind-bending exemptions to apply under the Freedom of Information Act 2000 (FOIA) is the exemption for personal information (s.40) (although sections 30 and 36 are also up there!). This is partly due to s. 40’s close link with the Data Protection Act 1998
FOIA: new research exemption comes into force
On 1 October, a new exemption (the “New Exemption“) relating to continuing programmes of research came into force under the Freedom of Information Act 2000 (“FOIA“). Its intention is to protect information pertaining to on-going research from premature disclosure. Section 22A FOIA – inserted by the Intellectual Property Act 2014 (“IPA“) – provides that information
Off the record: Supreme Court sides with Charity Commission in FOIA appeal
The Supreme Court has ruled that the absolute exemption contained in s.32(2) of the Freedom of Information Act 2000 (“FOIA“) continues to apply to information obtained or created by a person conducting an inquiry even after the termination of that inquiry. The decision was not without dissent, however, with the minority of the Court considering
A right royal mess: Court of Appeal quashes FOIA veto for first time
In a judgment handed down yesterday, the Court of Appeal has – for the first time – quashed a decision of the Attorney General (“AG“) to veto an Upper Tribunal (“UT“) order that documents be disclosed under the Freedom of Information Act 2000 (“FOIA“).
Government policy on transparency comes back to haunt the Cabinet Office
In February 2010, the then Labour Government announced its intention to reduce the period in which Cabinet Office papers were considered confidential from 30 years to 20 years. It therefore included an appropriate amendment to the Public Records Act 1958 in the Constitutional Reform and Governance Act 2010. This was one of the last policies
Disclosure of employment equality data “necessary” under Data Protection Act
A Scottish council has been required to provide data indicating whether it pays traditionally “male” jobs more than traditionally “female” roles, after the Supreme Court rejected its argument that Data Protection legislation prevented disclosure. The case provides clarification on what is meant by the requirement that disclosure, and other forms of data processing, be “necessary”
High Court concerned by executive veto, but Black Spider remains in the shadows
The High Court has expressed concern over the “constitutional aberration” that allows the government to block disclosure under the Freedom of Information Act, but upheld the application of this veto to the so-called “Black Spider” letters sent by Prince Charles to various government departments. The case is interesting both for its position within the wider
Information Alchemy: amendments to the Re-use Directive offer up new commercial opportunities
On 26 June 2013, the EU adopted Directive 2013/37/EU which amends existing Directive 2003/98/EC on the re-use of public sector information (the “Re-use Directive“), creating a harmonised regime for the re-use of public sector information (“PSI“) by private businesses and individuals across Member States. Among other things, the amendments will: create a right to the
Freedom of Information in the private sector?
The Confederation of British Industry (“CBI“) has revealed that it is developing “transparency guidelines” that will apply to private companies that provide services to the NHS (the “Guidelines“). The CBI’s public service strategy board, which includes managers and directors from some of the UK’s most high-profile outsourcing firms, will be responsible for drawing up the
Review of issues for 2013
The following is a summary of some of the key issues Congress and the Administration will be debating in 2013. Please contact us with any questions. We are happy to provide further analysis as well as insight into other areas of interest. Agriculture: Tom Vilsack is expected to stay on as Secretary of Agriculture. The
Moving FOIA forward: the Government gives its view
In July, as described on this blog, the Justice Committee published a post-legislative report on the operation of the Freedom of Information Act (“FOIA“). Last Friday, the Government published its response.
Refusing disclosure of Prince Charles’ letters; further use of the Ministerial veto
In September, on this blog, we questioned whether use of the Ministerial veto under s.53 of the Freedom of Information Act 2000 (“FOIA“) to prevent disclosure of information subject to FOIA requests was becoming increasingly routine. A month later, we can report that the veto has been used again, this time to prevent disclosure of
DWP in FOIA disclosure
The Information Commissioner (the “Commissioner“) has again rejected an attempt to rely on the commercial prejudice exemption, highlighting the risks which private companies should consider when engaging with the public sector as a result of the Freedom of Information Act (“FOIA“). It also demonstrates the need for private companies to liaise closely with public authorities
FOIA finally receives some support
The Justice Committee has this week published its report on the Freedom of Information Act (“FOIA“),[1] with the media leaping on its criticism of Tony Blair’s failure to provide it with oral evidence. Contrary to Mr Blair’s suggestion in his book that FOIA has proved to be “antithetical to sensible government“, the Committee concludes that FOIA
DC Circuit FOIA Ruling Extends Unique Non-Disclosure Rights of Intelligence Agencies To Alleged Collaboration With Google
By Todd R. Overman, Daniel Greenspahn, and David Robbins On May 11, 2012, the U.S. Court of Appeals for the District of Columbia Circuit ruled that the National Security Agency (NSA) properly refused to confirm or deny whether records exist regarding the alleged cyber-security collaboration between NSA and Google in response to a Freedom of
Health Secretary defies order to disclose advice on National Health Service reform risks
In defiance of the First-tier Tribunal’s decision that the Department of Health should disclose a transition risk register advising on the risks of implementing the proposed reforms of the NHS, Andrew Lansley, the Health Secretary, has invoked a rarely-used ministerial veto and refused to publish the register. In doing so, Mr Lansley stated that while