Freedom of Information Act 2000

1. Freedom of Information Act 2000 Sarah Hanson Partner CMS Cameron McKenna LLP E-mail: Sarah.Hanson@cms-cmck.com Tel: +44 (0) 20 7367 2559

2. Freedom of Information Act 2000 • Fully in force from January 2005 • applies retrospectively • Applies to public authorities: • listed in Schedule 1; • designated by the Secretary of State; and • companies that are publicly owned • Act is regulated by the Information Commissioner

3. Public Authorities • Advisory bodies covered by FOI requests include: • Medicines and Healthcare products Regulatory Agency • Medicines Commission • Committee on Safety of Medicines • Advisory Board on registration of homeopathic products • British Pharmacopoeia Commission • Veterinary Products Committee

4. Codes of Practice • The “Access Code” • The “Records Management Code” • Operate alongside the Act • Responsibility of Secretary of State to keep codes current

5. Provision of Information • “Information” – recorded in any form • Publication scheme • Information must be disclosed if: • held by a public authority (except on behalf of another person); or • held by another person on behalf of the authority • Held at the time when request is received

6. Provision of Information cont. • No restriction on purpose of application • Request: • must be in writing (can be received by email) • state the name of applicant and address for correspondence • describe the information requested • Public authority must provide that information within 20 working days

7. Duty to Disclose • Paul Harper v Information Commissioner • Cannot claim no longer hold info because employees have “deleted” it from computers • P Quinn v the Information Commissioner • Where PA cannot locate info still regarded as “holding” it… • but may refuse disclosure on the grounds that cost in doing so would exceed appropriate limit

8. Clarification/Fee • Public authority may request further information where the request is not clear • Requests that cost under £450 are free (except for incidental costs, photocopying etc) • If over £450 can refuse to answer or elect to charge a fee for providing information within regulations set by Secretary of State • Fee to be paid in advance • Consultation of amended FOI fees regulations

9. Advice and assistance • Public authority must provide advice and assistance as far as reasonable to applicant • Access Code provides guidance on what is “reasonable”: • advised of progress • advising potential applicant of rights • assisting applicant to focus request • advising on alternative availability • Should try to give effect to applicant’s preference as to format in which information is provided • if not reasonably practicable,notify applicant of reasons

10. Exemptions • “Absolute exemptions” (info need not be disclosed) • “Qualified exemptions” (public interest test) • in all the circumstances does the public interest in maintaining exclusion outweigh the public interest in disclosing? • presumption: in the public interest to disclose • Exemption can apply to whole or parts of information

11. Exemption - Guidance • Likely to be in public interest if: • facilitates transparency / accountability of decisions • understand / challenge decisions affecting applicant • assist understanding / debate of issues of day • facilitate transparency / accountability of spending public money • bring to light information about public health and safety • Authority will take account of a number of factors: • fact that information is technical, complex and may be misunderstood may not be a reason to withhold disclosure; • whilst the fact that information may be misleading if it is incomplete could be a reason to withhold disclosure

12. ABSOLUTE Available by other means Security services Court records Parliamentary privilege Provided in confidence Prohibited from disclosure by law or regulation Personal data QUALIFIED Future publication National security/ defence etc. Law enforcement /proceedings Audit / Govt policy Royal household Prejudice effective conduct of public affairs Environmental / Health & Safety Legal prof privilege Commercial interests Personal data Exemptions

13. Refusal of a request • Where authority refuses request because of exemption, authority must: • within 20 days notify applicant that request refused • specify exemption relied on • state (if not apparent) why exemption applies • If authority refuses a request: • notification must include complaints policy (if any) and • explain right of applicant to apply to Information Commissioner for decision

14. Freedom of Information Act 2000 & the MHRA • Publication Scheme • Classes include: • organisational structures • corporate publications • guidance notes and application forms • vigilance schemes • RAMA database

15. Memorandum of Understanding • Common understanding of what will be disclosed, withheld, or disclosed only after consultation with third parties: • not legally binding; • application of public interest test may result in different outcome to those set out in the Memorandum; and • working document subject to review • Signatories: • MHRA (medicines division) • Veterinary Medicines Directorate • Association of British Pharmaceutical Industry • Proprietary Association of Great Britain

16. Traffic Light Document Part 2 of the Memorandum of Understanding sets out likely disclosure responses using a ‘traffic light’ system: G* = already published routinely G = disclosure on demand without consultation A = disclosure on demand after consultation with relevant third party (subject to editing out of commercial confidential information) R = anticipated that disclosure will not take place as information will be confidential, commercially sensitive or information which would otherwise be exempt from disclosure

17. Draft MHRA & VMD Guidance • June 2007 MHRA & VMD prepared: • “Guidance on the disclosure of types of Human and Veterinary Medicines Information held by the Human and Veterinary Regulatory Authorities” • Due to replace MOU which: • “had not adequately reflected the greater spirit of openness and commitment to disclosure”

18. Exemptions to Disclosure • The most relevant exemptions to disclosure are: • information provided in confidence • prejudice to commercial interests • personal information • information intended for future publication • investigation and proceedings conducted by public authorities

19. Prejudice to Effective Conduct of Public Affairs (Qualified) • Information held by a public authority exempt where reasonable opinion of qualified person: • would / likely to inhibit: • free and frank provision of advice, or • free and frank exchange of views for the purposes of deliberation, or • would otherwise prejudice or likely to prejudice effective conduct of public authority

20. MHRA - rofecoxib • Request for information re safety and efficacy of a medicine • Including reviews/analyses/reports and results of clinical trials • MHRA disclosed some information however cited the “prejudice to effective conduct of public affairs” exemption (amongst others) with respect to the rest of the information • Minister responsible believed exemption had been properly applied

21. Health and Safety (Qualified) • Information is exempt where disclosure would, or would be likely to: • endanger the physical or mental health of any individual, or • endanger the safety of any individual • May apply to documents submitted by MHRA by a company that (directly or indirectly) link named individuals with animal experimentation

22. MHRA - rofecoxib • In case above MHRA also argued that the health and safety of individuals at risk from animal rights activists • those directly and indirectly involved • also employees at named organisations may be at risk • Public interest test considered and favoured maintaining the exemption

23. Favouring disclosure: Regulation of medicines matter of significant public interest Increase scrutiny, openness and transparency Only a few animal rights activists would carry out violence Against disclosure: Increase risk of violence / intimidation Connected persons at risk Public interest is in ensuring MHRA has acted within its rules and regulations not in knowing individual names MHRA – rofecoxib – public interest test

24. Personal Data Exemption (Qualified and Absolute) – s.40 • Where applicant is the data subject access is governed by DPA 1998 • Where applicant is not the data subject and where disclosure would: • contravene data protection principles = absolute exemption • cause damage or distress = qualified exemption

25. Information provided in confidence (Absolute) – s.41 • Exemption applies if information obtained by authority from any person and disclosure constitutes an actionable breach of confidence • Confidentiality provision in contract can be implied if not explicit • Nature of information important not its label – can change over time

26. Newcastle upon Tyne NHS Trust – August 2006 • Refusal to disclose external report prepared following criticism of expert evidence • Report was obtained from “any other person” in that it was obtained from the independent panel of experts • IC considered whether the report would have the “necessary quality of confidence” • Information: • could not be said to be trivial; • was not in the public domain; and • subject to a confidentiality clause • ‘Prior written approval” of advisors needed – unanimously declined • Held that release of information would be an actionable breach

27. Epsom & St Hellier NHS Trust – October 2006 • Mother requested ‘all information concerning my daughter’ including health records • Medical records had the necessary quality of confidence – implicitly created by nature of doctor/patient relationship • If breach would affect the conscience of the defendant then information could be restrained even where it would not damage the confider • Duty of confidence can survive the death of the person • Act designed to be applicant blind so will not take into account unique circumstances of case • Held exemption applied to medical records and “chunks” of the legal file

28. Practical Tips • Take steps to protect information when it is submitted • redact personal data • keep confidential and non-confidential material separate • Set out circumstances where and reasons why the information is confidential, and for how long • Personal Data / Confidential Information willl not remain so indefinitely • Protective markings: however, serve only a primary indication and cannot always be relied upon

29. Commercial Interests (Qualified) - s.43 • Trade secrets exempt • “competitive edge” • economic value from not being generally known • Would / would be likely to prejudice commercial interest of any person (including public authority) • real and significant risk of prejudice • does not apply to ‘historical records’ – more than 30 years old

30. Is information “commercially sensitive”? • Guidance by IC sets out questions to be considered: • Used for the purpose of a trade? • Obvious / made clear that releasing would cause harm / benefit competitor? • Is knowledge restricted to a limited group? • How easy for competitors to discover / reproduce information? • Will apply where disclosure would have a significant impact on revenue/ability to secure finance • not if would simply cause embarrassment

31. MHRA – January 2007 • Subject access request made for document concerning allegations made in request of the quality of analysis performed by a specified individual • Relevant document split into two sections – diary of investigation and results of the investigation • Qualified exemption – need to show that release would harm someone’s commercial interest and that exemption outweighs public interest • Commercial interest exemption • must be a “significant risk” of prejudice • passage of time helped to demonstrate low risk of prejudice • Held that public interest in disclosure outweighed that against disclosure

32. Tendering for Public Authority Contracts • All communication during tendering process may be subject to disclosure • Info that would be sensitive during tendering process may no longer be so once contracts are signed • Public Interest favouring disclosure: • Increased understanding of decision making process. • May encourage competition • Increased transparency and accountability of spending of public money

33. Practical Tips • Clearly identify what info is commercially sensitive and for what period it will remain so • Annex sensitive info in a schedule / appendix to main document • Don’t make blanket claims of “commercially sensitive” • Agree all confidential information to be returned once no longer required by public authority • Use confidentiality clauses where appropriate

34. Information available by other means (Absolute) • Information must be “reasonably accessible” to public by other means • even if only available on payment of a fee • Includes information available under a publication scheme

35. Information intended for future publication (Qualified) • Must be reasonable to withhold information until that date • Intention to publish must be firm e.g. where info already prepared for publication • The date of publication need not be determined • Drafts may be covered where final version is intended for publication • Also applies to info held by a public authority that another person intends to publish

36. Pesticides Safety Directorate • Request for lists of safety studies carried out on two named pesticide ingredients • Notifiers submit to PSD prescribed info - PSD then generates draft report to be placed on EFSA website within 6 weeks • full report is later placed on website – may be several years later • Complainant requested this info in advance of its publication on website • Held – reasonable to withhold disclosure

37. Public Interest favouring disclosure Delay was over and above 6 weeks Earlier disclosure would facilitate work Public Interest against disclosure Undermine the approval process Info was not yet available to EFSA PSD - Information intended for future publication – public interest test

38. Practical Tips • The sooner the time for intended publication the more likely the exemption is to be upheld • Provide list of planned publications e.g. on website • Provide a timetable containing intended dates of publication

39. Legal Professional Privilege (Qualified) • All communication with professional legal advisor is confidential and will not be revealed without consent • no need to demonstrate potential for ‘prejudice’ • even trivial information may be covered by exemption • Qualified exemption – therefore necessary to consider public interest test

40. Public Interest Considerations – Guidance issued by IC • Timing of disclosure • Has litigation ended or is ongoing / threatened? • Policy Advice • Public interest in promoting public debate and increasing accountability • Access to justice and right to fair trial • Strong arguments against disclosure where access to justice may be prejudiced

41. MHRA – January 2007 • Complainant requested: • all info between September 01 and March 02 relating to an individual and MCA, and • in full all info regarding the formal report • MHRA: • under first request, provided 10 documents with personal data redacted • withheld all further documents requested citing legal professional privilege exemption • Held – exemption applied

42. MHRA – January 2007 cont • Going against established principle of confidentiality would discourage clients from seeking legal advice • Exemption is essential for the proper administration of justice • free and frank exchanges facilitate information sharing leading to better advice • Ability to seek legal advice without fear of future disclosure results in improved quality of decision making

43. Practical Tips Where in-house counsel giving advice: • Try to separate legal and non-legal matters • Try to separate within matters information that can be disclosed from information that cannot

44. Review Process If information is withheld: • Internal review by senior agency official not previously involved with the request • Such internal review procedure shall be detailed in the refusal notice • Information Commissioner will review where no / insufficient internal review

45. Sanctions • IC assesses good practice, compliance with Act and Codes of Practice • Failure to conform to codes of practice - “Practice recommendation” • Failure to comply with obligations under FOIA - “Enforcement notice” • Following investigation by IC - “Decision notice” identifies steps required or compliance • If IC requires further information to facilitate investigation - “Information notice” • IC can certify to court non-compliance with “notices” - contempt of court

46. European Medicines Agency • Public access to information held by EU institutions and agencies is governed by Regulation (EC) No 1049/2001 • Broadly similar to provisions in FOIA • Aims to promote citizen participation in decision making process and increase legitimacy and accountability • Applies to all documents held by an EU institution (or Agency created by an EU Institution) • Similar exemptions as under FOI Act - also utilises ‘Public Interest’ Test • EU institutions must consult third party where unclear whether exemption applies

47. Dangers • Competitors/press can use FOI Act to obtain information • Accidental disclosure of confidential / personal information • Avoid sanctions for non-compliance by seeking advice from IC on unclear matters

48. Protection • Educate staff • Mark submissions ‘Private & Confidential’ • Submit documents in two versions where possible • Written acknowledgement from MHRA • Do not ignore a notification from the MHRA

49. Useful Websites • www.ico.gov.uk • www.foi.gov.uk

50. Thank you for your attention Sarah Hanson Partner CMS Cameron McKenna LLP E-mail: Sarah.Hanson@cms-cmck.com Tel: +44 (0) 20 7367 2559