Freedom of Information Act 2000Freedom of Information Act 2000

Sarah Hanson

PartnerCMS Cameron McKenna LLPE-mail: Sarah.Hanson@cms-cmck.com

Tel: +44 (0) 20 7367 2559

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Freedom of Information Act 2000Freedom 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

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Public AuthoritiesPublic 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

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Codes of PracticeCodes of Practice

The “Access Code”

The “Records Management Code”

Operate alongside the Act

Responsibility of Secretary of State to keep codes current

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Provision of InformationProvision 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

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Provision of Information cont.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

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Duty to DiscloseDuty 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

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Clarification/FeeClarification/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

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Advice and assistanceAdvice 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

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ExemptionsExemptions

“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

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Exemption - GuidanceExemption - 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

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ExemptionsExemptions

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

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Refusal of a requestRefusal 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

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Freedom of Information Act 2000 & the Freedom of Information Act 2000 & the MHRAMHRA

Publication Scheme Classes include:

– organisational structures– corporate publications– guidance notes and application forms– vigilance schemes– RAMA database

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Memorandum of UnderstandingMemorandum 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

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Traffic Light DocumentTraffic 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

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Draft MHRA & VMD GuidanceDraft 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”

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Exemptions to DisclosureExemptions 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

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Prejudice to Effective Conduct of Public Prejudice to Effective Conduct of Public Affairs (Qualified)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

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MHRA - MHRA - rofecoxibrofecoxib

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

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Health and Safety (Qualified)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

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MHRA - MHRA - rofecoxibrofecoxib

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

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MHRA – MHRA – rofecoxib – public interest testrofecoxib – public interest test

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

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Personal Data Exemption (Qualified and Personal Data Exemption (Qualified and Absolute) – s.40Absolute) – 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

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Information provided in confidence Information provided in confidence (Absolute) – s.41(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

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Newcastle upon Tyne NHS Trust – Newcastle upon Tyne NHS Trust – August 2006August 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

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Epsom & St Hellier NHS Trust – October Epsom & St Hellier NHS Trust – October 20062006

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

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Practical TipsPractical 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

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Commercial Interests (Qualified)Commercial Interests (Qualified) - s.43 - 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

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Is information “commercially sensitive”?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

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MHRA – January 2007MHRA – 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

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Tendering for Public Authority ContractsTendering 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

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Practical TipsPractical 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

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Information available by other means Information available by other means (Absolute) (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

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Information intended for future Information intended for future publication (Qualified)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

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Pesticides Safety DirectoratePesticides 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

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PSD - Information intended for future PSD - Information intended for future publication – public interest testpublication – public interest test

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

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Practical TipsPractical 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

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Legal Professional Privilege (Qualified)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

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Public Interest Considerations – Public Interest Considerations – Guidance issued by ICGuidance 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

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MHRA – January 2007MHRA – 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

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MHRA – January 2007 contMHRA – 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

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Practical TipsPractical 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

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Review ProcessReview 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

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SanctionsSanctions

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

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European Medicines AgencyEuropean 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

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DangersDangers

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

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ProtectionProtection

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

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Useful WebsitesUseful Websites

www.ico.gov.uk www.foi.gov.uk

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Thank you for your attention

Sarah Hanson

PartnerCMS Cameron McKenna LLPE-mail: Sarah.Hanson@cms-cmck.com

Tel: +44 (0) 20 7367 2559