Your Right to Know - Freedom of Information

ABPI Response to the Government White Paper

Introduction

The pharmaceutical industry is one of the most highly regulated industries. Virtually every aspect of the discovery, development, marketing approval, post marketing surveillance and sales of a medicine is regulated.

The pharmaceutical industry welcomes moves to greater transparency and greater access to official records and information. The industry has demonstrated its commitment to greater patient access to information by the introduction of its own scheme under which companies will provide more detailed information to enquirers about medicines ("Know More About Your Medicines").

The commitment to greater transparency, however, is balanced with the need to protect certain types of information which may compromise the safety of an individual or premises, and the need to protect commercially sensitive information.

The industry believes that experience in other jurisdictions, in particular in the US, as well as in the EU, demonstrates that it is possible to find an appropriate balance between freedom of access to information, and non-disclosure of information which may be damaging to individual or commercial interests.

In considering the principles set out in "Your Right to Know", we have reviewed the rules applied in other jurisdictions and believe that comparable standards can be adopted in the UK. The application of such principles to individual types of information is reviewed in detail below.

Principles with regard to access to information held by government relevant to pharmaceutical companies

1. The UK should not move to a system of access to information which discloses more than would normally be disclosed in the US or elsewhere in the EU.
2. Data which may lead to any invasion of individual or personal privacy should not be disclosed.
   This may include information in clinical trial reports submitted to the Medicines Control Agency. This is also particularly important with regard to information which identifies individuals who work in laboratory animal research facilities or are responsible for those facilities.
3. Commercial confidentiality should be preserved. We agree that trade secrets, intellectual property, data which would vitiate exclusivity provisions, or data which could affect share prices should not be disclosed. (See Annex A).
4. Certain types of information may be commercially sensitive within certain timeframes or in relation to a given context.
   This time or context sensitive information should be retained as confidential until such time as it is appropriate to release it. An example of this includes the early disclosure of clinical trial findings or research undertaken by a company, which may be market sensitive information.
   Similarly, premature disclosure of the opinions of the Committee on Safety of Medicines or the licensing authority with regard to regulatory action concerning a medicine can be market sensitive. Such information, for example with regard to adverse reaction report findings - pharmacovigilance - may unnecessarily alarm members of the general public unless it has been subject to appropriate evaluation and review. It should only be released in an appropriate manner, such that unnecessary public alarm is not generated.
5. Information supplied in confidence under present statutory confidentiality provisions should remain confidential. The provisions in section 3.11.6 of the White Paper are welcome in this regard.

Examples of types of information handled by regulatory authorities relevant to the pharmaceutical industry

1. Information relating to clinical trials
   Information concerning the conduct of clinical trials is submitted to the Medicines Control Agency and to Ethics Committees in confidence. Both the fact that trials are taking place, and also any data relevant to findings in trials should be regarded as confidential, and not subject to any disclosure.
   No investigational data are disclosable to the public under US Freedom of Information Act (FOIA) provisions prior to approval of the product. Indeed, the FDA will not disclose the existence of an Investigational New Drug application unless the sponsor has previously disclosed such information.
   Such information is of significant advantage to competitors and is often market sensitive.
2. Investigational research in laboratory animals during discovery or development of new medicines
   Information that studies are taking place, and the nature of the studies, is competitive information and is market sensitive.
3. Submissions to the Medicines Control Agency
   Substantial amounts of confidential data are submitted to the Medicines Control Agency in support of an application for a new market authorisation for a medicine.
   In the US, once a product is approved, summaries of safety and effectiveness data submitted with or incorporated in the application can be disclosed. This is normally provided in the form of "Summary Basis of Approval" (SBA) which is a summary document prepared either by the applicant or by the FDA reviewer. Trade secret or confidential commercial information as defined under the US FOIA is not generally disclosable, for example information about manufacturing methods or processes.
   The situation is similar in the EU centralised procedure. The European Medicines Evaluation Agency prepares a European Public Assessment Report which is similar to the US Summary Basis of Approval in that it provides an overview of safety and efficacy data and does not disclose confidential commercial information.
4. Regulatory assessments, communications and information concerning decision making
   MCA assessors prepare assessment reports and other documentary information based on the confidential dossier from the applicant for a marketing authorisation for a new medicine. This information may be for internal use or for submission to the Committee on Safety of Medicines or another Section 4 Committee. Assessment reports are normally provided to applicants after the deliberations of the assessor and/or relevant Section 4 Committee are completed.
   Similar assessment reports provide the basis for preparation of a European Public Assessment Report in the EU and can be used as the basis for a similar summary basis of approval document in the UK.
   Industry is not in favour of disclosure of correspondence or other material normally used to support the normal business of the Medicines Control Agency. Any requests for disclosure of such information should be the subject of consultation with the applicant who may be affected by disclosure of such information. This is particularly the case where premature disclosure may affect share prices, compromise intellectual property or data exclusivity, or mislead the public causing unnecessary public disquiet.
5. Compliance information
   The Medicines Control Agency (and other authorities such as the Home Office) may gather information in the course of normal compliance and enforcement action. Whilst the industry would in no way wish to hide any information concerning poor or inappropriate practices, nevertheless it is urged that public disclosure of information derived from the compliance activities of the relevant inspectorates is only available to the public at the conclusion of an investigation. This, again, is consistent with current practice in the USA where any information during compliance investigations is not disclosable.
   Similar provisions should be applied to other compliance activities, for example good laboratory practice inspection, good clinical practice inspection and also arrangements surrounding product recall, the generation and issue of "Dear Doctor" letters and other compliance activities with regard to trading practices. In case of uncertainty, the applicant/company concerned should be consulted and given an opportunity to comment prior to disclosure.

Issues raised in the White Paper

• Para 2.2.5 - scope of application of the Freedom of Information Act
  Comments above focus primarily on government departments and their executive agencies. Industry believe that similar principles should apply to the National Health Service and other organisations involved in statutory functions. Similarly all applicants for information, particularly belonging to public or private bodies should be subject to similar provisions.
• Para 2.33 - fees and charging systems for information searching under Freedom of Information
  The industry accepts that charging fees for information searching under Freedom of Information is reasonable. Experience in the US suggests that commercial and corporate users make 95% of applications under the US Freedom of Information Act but question whether a two-tiered charging approach is viable.
• Para 3.1.4 - key specified interests
  We agree with the seven proposed key specified interests concerning disclosure. We have commented above on the interpretation of some of those specified interests. We support the need to recognise the importance of protection of commercial confidentiality, particularly with regard to trade secrets, all intellectual property and any information which is market sensitive and could affect share prices.
• Para 5.1.9 - third party rights of appeal
  We believe that it would be helpful to establish a mechanism to allow third parties to appeal against decisions to release information which they believe would cause substantial harm to their interests. Such a mechanism should enable rapid resolution of any differences of view between applicants for information, those who hold or own the information and those who may be affected by disclosure of the information. Such rights of appeal should be transparent, and operate efficiently.

Annex A - Freedom of information in relation to innovation

1. Intellectual Property/Trade Secrets

Intellectual property takes various forms but can be broadly divided into two categories. Firstly, there is that type of intellectual property which is essentially created by statute (whether directly or by means of some form of registration process), for example copyright, design right, patents, trade or service marks and registered designs. In the context of FOI, the essential validity of such intellectual property may not be compromised by disclosure but any intellectual property rights in third party material disclosed must be recognised. For example, if a third party copyright work were disclosed in response to a request under FOI, a warning may be necessary to prevent further copying etc. in breach of copyright.

The second type of intellectual property comprises confidential information or know-how, which may include technical information as well as business intelligence such as customer lists/marketing plans etc. ("trade secrets"). This form of intellectual property depends for its existence, validity and value on the fact of its limited availability, ie. confidentiality. It is therefore essential that FOI legislation is framed so as to provide protection for such information, where disclosure could compromise it irrevocably and therefore cause substantial harm to the third party which originally provided it.

From the pharmaceutical industry perspective, examples of this type of information would include:

• manufacturing methods or processes
• production, sales, distribution and similar data
• the results of tests or trials to the extent that they have not (yet) formed part of a patent application or a marketing authorisation application or been otherwise published (see further below)
• compliance procedures and issues prior to resolution/conclusio

2. Data Exclusivity

In the UK, the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (SI 1994/3144) implemented the relevant EU legislation, Article 4.8 (a)(iii) of Directive 65/65/EEC (as amended). In line with the majority of the major pharmaceutical producing Member States in the EU, the data exclusivity period for all licensed medicinal products was fixed at 10 years from marketing authorisation.

It is imperative that none of the intellectual property rights (including the right to data exclusivity) referred to above are compromised under FOI and we would therefore ask that all of them are taken fully into account in the context of any information which is proposed to be disclosed by the Medicines Control Agency or similar bodies, particularly in relation to information supplied in the process of obtaining a marketing authorisation.