HOW THE MEDICINES CONTROL AGENCY RESPONDED (30 April 1998) TO QUESTIONS FROM SOCIAL AUDIT (7 & 10 MARCH, 1998) - WITH QUESTIONS & ANSWERS DETAILED, ONE BY ONE. QUESTIONS IN ITALICS, RESPONSES NOT.

I am writing with a number of queries arising from the MCA's submission of 9th February to the Select Committee on Public Administration, and please will you treat them as formal requests under the Code. I am also sending a copy of this letter to the Clerk of the Committee, if only to illustrate what the MCA sometimes has to put up with in dealing with Code requests.

1. Further to Peter Dunlevy's letters of 19 March and 6 April, I am now able to reply to your letters of 7 and 10 March and have followed the order in which you set your points out. I am sorry this reply has taken longer than we would wish. However, we needed to seek the views of others and research our records on some of the matters you raised which, as explained in Peter Dunlevy's letter of 6 April, did not in our view strictly constitute requests for information under the Code of Practice. I am similarly copying this letter to Dr Paul Seaward, Clerk to the Select Committee on Public Administration.

2. As a general observation, I agree that your letters do illustrate, as you suggest, the type of requests we receive under the Code. It also goes some small way to validate our view that we will face more complex requests for information in the future. You may also wish to note that whilst we handled fewer than 20 Code requests in the whole of 1997, we have reached 25 in the first quarter of 1998.

You told the Committee that: "The MCA already releases a great deal of information to the public, including information on adverse drug reactions." You specifically represented this as an illustration of the Agency's policy "to make as much information available as possible within the terms of the Code of Practice on Access to Government Information." Would you not accept that that this fundamental change of policy was the direct result of a series of complaints and requests for information under the Code, made by Social Audit and Health Which? and that the MCA went to great lengths to resist them?

To recap: our initial request was made in January 1996, but it took until February 1997 for you to confirm that "We are changing our practice and our internal standard operating procedures accordingly, with immediate effect." The thick correspondence between us confirms it was a real slog from start to finish. It seems neither fair nor straightforward to suggest this gives any real evidence of a policy "to make as much information available as possible within the terms of the Code…" The outcome certainly represents improvement, but the whole process was clearly driven by a need for damage limitation, not by any underlying determination to disclose.

3 . You asked if the MCA accepts that it fundamentally changed its policy on releasing ADR data to the public as a direct result of a series of complaints and requests for information under the Code from Health Which? and Social Audit Ltd between 1996 and 1997. Perhaps I can address this by giving some background as I see it, though we have not researched in depth the entire history nor the contribution made by yourself and Health Which? to this development.

4. It has long been the MCA's practice to provide, from the UK spontaneous ADR scheme, anonymised aggregated ADR data (reports from doctors, and more recently some pharmacists, of suspected adverse reactions to prescribed medicines) on request. Such data have been available for many years. They were initially available to health professionals and to companies who held a licence for the relevant drug. There were exceptions, and you have previously told me that you have requested and received these data from us since 1984. Gradually, the MCA has extended availability over the years. In March 1995, the Agency broadened the policy to the extent that, with certain limitations, such data were available to anyone on request.

The main exception to this development were lawyers since the MCA considered at that time that making data available to them could damage the scheme and would be contrary to undertakings given to the doctors in respect of the purposes for which the data would be used.

5. In 1996, you questioned and complained about this policy as you outlined in your letter. In the light of your complaint, the MCA conducted a review of the position, and extended its policy from February 1997, so that ADR data would be available to all members of the public, including lawyers.

6. The Agency took this step primarily on the basis of the outcome of that review though, clearly, the events preceding it and your contribution were important factors in promoting this change. We needed to be sure that by extending availability, we would not jeopardise either the continued operation and further development of the scheme nor the trust of practitioners who provide this information in good faith for ADR purposes. As far as I am aware, this policy development has not jeopardised the ADR scheme, though I am not convinced that it was quite the fundamental change you have suggested.

7. You say that it is unfair of the MCA in my reply to the Select Committee to claim its policy on release of ADR data as evidence of a policy to make available as much information as possible within the terms of the Code of Practice. I am concerned that you think this is so, though I appreciate that the pace of change on this particular initiative may not have been as fast as you personally would have wished. We now make ADR information available to anyone on request. We are continuing to review our policies on access to information in advance of FOI legislation as outlined in our reply to the Select Committee and in the light of comments from the public consultation on the White Paper.

The problems that we and others have always faced with the MCA/CSM, when seeking disclosure, have been thickly underlined by the CSM Chairman's recent and remarkable confirmation that he personally thinks there is far too much secrecy in the system:

"A small part of individual [license] applications might be regarded as commercially confidential but the major proportion could, with little loss to anyone, be made publicly available. Similarly, I see no objection to Committee's papers being publicly available".

Bearing in mind that, on leaving office, the previous Chairman of the CSM also complained quite emphatically about the secrecy2, these questions arise, and I would be grateful for your response to them:

[a] Would it be safe to assume that the MCA also accepts that most of the commercial confidentiality is unnecessary? Can you please confirm, at least, that there is no fundamental difference of opinion on this between the MCA and CSM?

[b] Would it not have helped the Select Committee to indicate either that the CSM Chairman's views were generally shared, or that there was some significant divergence of opinion here?

8. You cited the views of Professor Rawlins, the current Chairman of the Committee on Safety of Medicines (CSM) - which advises Ministers on questions of the safety, efficacy and quality of human medicines and encourages ADR data collection and analysis - on commercial disclosure of information. You have in fact quoted from a letter Professor Rawlins originally wrote to you in July 1987. He recently agreed in his letter to you of 19 January 1998 that you could cite this again at a meeting at the Ying's Fund at which you both spoke but stressed that this was his personal opinion and not necessarily that of the CSM.

9. I cannot therefore agree that this represents, as you imply, a fundamental difference of opinion between the MCA and CSM, nor, as you suggest, that we should have indicated such possible differences in our reply to the Select Committee. The CSM is considering the Government's proposals for freedom of information, and is perfectly entitled to formulate its own views on how the principles of FOI can be taken forward in relation to its duties.

10. You asked whether the MCA accepts most commercial confidentiality is unnecessary. Our position on this is that we work within the terms of the Code of Practice and will, in due course, operate within the terms of FOI legislation when that takes effect. As I have already indicated, Ministers have asked us to see what more we can do to make information available in the interim and we believe we can make further progress here.

What explanation can you give for the Scrip report (14-01-98) that the MCA would be "trying for exemption" - ie seeking to join the list of agencies exempted from the proposed FOI Act? It was an extraordinary statement to read (and Scrip is usually a reliable source), all the more so in the light of the MCA's comments to the Select Committee.

11. You asked for our explanation of the statement in Scrip World Pharmaceutical News (14 January 1998) to the effect that the MCA was "trying for exemption" from the FOI White Paper. As it has never been our policy to seek such an exemption, I regret I can offer no such explanation and would suggest you contact the journal if you wish to pursue this further.

12. My reply of 9 February to the Select Committee sets out our position on the White Paper. It is therefore of some concern that your letter of 7 March should seek to cast doubt on what I told the Committee. Perhaps you are unaware of the MCA statement broadcast on 4 March on the BBC Radio 4 programme "You and Yours" following an interview with you on medicines information in which you had repeated the allegation. For the record, this statement, which remains our view was:

"The MCA emphatically denies applying for any kind of exemption from freedom of information legislation. This is a misleading story without foundation. The Medicines Control Agency already makes a lot of information publicly available, and as a Government Agency, will fully implement any legislation when enacted."

3. Under Q5, you give your best estimate of the numbers of requests the Agency might handle after passage of a Freedom of Information Act. I don't doubt your numbers, and I do realise how hard it would be to come up with anything at all precise, but please could you let me have copies of:

[a] Any facts and analysis underlying the Agency's estimate;

[b] Any related calculation, made before 9th February, estimating the numbers or proportion of FOI requests that would be likely to originate from pharmaceutical companies (including their agents), rather than from private individuals or other seekers after truth.

[c] Any estimates the MCA presently has of the proportion of business-related, and all other, FOI requests handled by the US Food and Drug Administration.

[d] Any other data which might cause the MCA to doubt that the great majority of FOI requests it is likely to handle will originate from pharmaceutical companies.

13. You asked for information behind the MCA's "best estimate" of the number of requests we might handle. I would repeat that our reply to the Select Committee said that we cannot estimate the likely number of FOI requests accurately but suggested that it was not unreasonable to assume we shall be dealing with hundreds and possibly thousands of requests each year. I attach copies of FDA data on FOI for the year to December 1996 and also data for the 9 months to September 1997. These give details of the proportion of business-related and all other FOI requests handled by the FDA for which you asked. The FDA has now switched its annual reporting cycle from a calendar to a fiscal year (October - September) and will not be producing comparable data or charts for all of 1997 (though the total number of their FOI requests was 42,416 to 31 December).

14. Our reply set out some of the difficulties and other factors in estimating numbers but, using the FDA data, the following helps illustrate our estimate. Assuming:-

- the UK population (59m) is about 22% of the USA (270m);
- about 23% of the FDNs 1996 FOI requests relate to human medicines
   (we understand that within the category "drugs" only a small number
   of their FOI requests related to animal medicines - reference in the charts
   to "EIRS" means Establishment Inspection Reports);
- that this has remained consistent since 1975; and
- that requests in the UK peak sooner than in the USA:
Year 1 13,000 requests * 22% * 23% = UK equivalent of around 650 requests
Year 5 50,000 requests * 22% * 23% = UK equivalent of around 2,500 requests.

15. We estimated the average direct cost of the FDA dealing with an FOI request in 1996 as $190 by dividing $8.85 million by 46,656 requests. Using an exchange rate of 1 = $1.65, this average cost was equivalent to 115.

16. We estimated the FDA's average staff time of approximately 5 hours for an FOI request by multiplying the staff years x 40 hours x 48 weeks for the years 1993 to 1996 and dividing by the number of annual requests.

17. We have made no calculation of the number of requests likely to originate from pharmaceutical companies or their agents. However, we have noted current FDA data which show that in 1996, 39% of all their requests were from industry and 29% from FOI specialist service companies. We understand that the same proportions are applicable to requests for information about medicines. The corresponding figures for the first 9 months of 1997 were 34% and 28% respectively.

18. We have compared these data with our Code of Practice requests in the 12 months to 31 March 1998. Of 38 requests, 3 (8%) have come from pharmaceutical companies. We do, of course, receive many thousands of other requests each year which are not handled under the Code. Otherwise, we have made no assumptions about the source of the majority of FOI requests we will receive.

Apropos of this, it seemed rather coy to tell the Committee that the MCA's income "is principally derived from receipts for the services we provide", even if you did mentioned the MCA's Trading Fund status. As the Agency's income comes overwhelmingly from the pharmaceutical industry, via fees paid for the scrutiny of product license applications, would it not have been appropriate to refer in your submission to the Committee to:

[a] any implications for the Agency of having to find extra funding for the administration of FOI, and whether it could legitimately and readily do so by increasing license fees?

[b] whether the MCA's views on this were influenced by the expectation that the large majority of FOI requests might originate from (or on behalf of) pharmaceutical companies themselves?

[c] whether it would be appropriate and/or legitimate to recover costs from pharmaceutical industry requesters (including their agents), given that they already fund virtually the whole regulatory system via license fees?

19. I have noted your comments about costs and charges under FOI. I believe the answers to all your questions lie in the proposals set out in the White Paper at paras 2.28 - 2.34. Charges would primarily be based on the type, rather than the source, of the request though the White Paper also sought views on the desirability and viability of a tiered charging system with higher charges for commercial and other corporate FOI enquirers. There will also be "gateways" (paras. 2.23 - 2.27) to encourage responsible use of the Act and deter unreasonable and frivolous requests.

20. One of the basic assumptions is that the bulk of the costs of FOI will be borne by the public authorities themselves. In addition, public authorities will be able to set their own FOI fees and charging structures within certain parameters and these will be subject to oversight from the Information Commissioner.

21. As with any Government initiative, we will seek to implement FOI efficiently and effectively within the overall resources available to us at that time, taking account of our business priorities and plans, including the duties which we are required to fulfil under FOI.

Finally, the MCA submission to the Committee refers to the need to protect "commercial confidentiality … such as intellectual property, sensitive information about product methods and techniques". In this connection, please would you let me have copies of any definitions or guidance relating to the meaning and interpretations of these terms that the MCA relies on, including all such references in current SOPs? May I also please request copies of any discussion relating to commercial confidentiality, recorded in (extracts of) Minutes of meetings of the CSM, over the past five years?

I would be very surprised (and reassured) if the MCA/CSM's concerns did primarily relate to the need to maintain confidentiality for those classes of information where disclosure is not the norm. I would think the MCA might get good support from consumer interests if it sought mainly to restrict disclosure relating to production technologies (not normally disclosed) - as opposed to the results of clinical and other tests relating to drug safety and efficacy. With this class of information, disclosure is the norm, even if there is an overwhelming bias towards publication of positive results, (with potentially dire consequences for the health and safety of some patients)

22. You say that our reply to the Select Committee refers to the need to protect commercial confidentiality. Perhaps I may recap what was said: "Commercial confidentiality generally will be an important concern for the pharmaceutical industry who we expect will wish to ensure their legitimate interests - such as intellectual property, sensitive information about production methods and techniques - are properly safeguarded."

23. This was not an attempt on our part to define the term but to offer our view of what we expected to be the position of the pharmaceutical industry in response to the White Paper's proposals. We must similarly take account of the views of others, such as consumer groups, as we explained in our reply to the Committee. I would perhaps add that we recognise the sensitivities this issue raises and would repeat that we are keen to receive the views of a range of interested parties on how we can best work with them to address concerns they may have in the context of preparing for FOI.

24. You asked for copies of all definitions of the term commercial confidentiality within MCA Standard Operating Procedures and I am grateful for your further clarification of this request. I am not aware of a single definition which applies across the Agency. This is not surprising since, if we are asked to release information under the Code of Practice which has been supplied as commercially confidential, our policy is to check whether it remains so and, if it does, then decide whether or not to release it. However, we cannot do this for every enquiry we receive. Thus, the types of information which are currently covered by this term within the MCA's Information Centre are given in the attached guidance notes on enquiries (No. 26), external enquiries (No. 27) and commercial confidentiality (No. 28). We are considering, as part of our ongoing review, whether some of these types of information should now be considered for release and we will make further announcements in due course. Please note that part of one paragraph has been deleted from No. 27 (under Exemption 4(e) of Part II of the Code of Practice) as this relates to an internal security matter for MCA and its staff. Disclosure of this information would risk prejudicing staff safety. If you wish to ask for a review of this decision, you should write to Dr Keith Jones at the above address in the first instance. After that, if you remain unhappy, you may refer the matter to the Ombudsman.

25. Within our Licensing Division, pre-licensing information is treated as commercially confidential. I am not aware of guidance within our Post-Licensing Divisions which defines this term further. We estimate that to scrutinise the records in Inspection and Enforcement Division for this information would take 21 hours. The first hour is free, followed by a charge of 20 per hour, making a total of 400. I must point out that I cannot guarantee that these records will contain any such information or definition. However, if you would like us to go ahead with this work, please send a cheque or postal order made payable to the Medicines Control Agency quoting reference OG 98/18 and this letter to the Cashier, Room 1615 at the above address. If you wish to ask for a review of this charge, please write in the first instance to Dr Jones. After that, if you remain unhappy, you may refer the matter to the Ombudsman.

26. You asked for copies of any discussions relating to commercial confidentiality recorded in the minutes of CSM over the past 5 years. I am seeking the views of CSM on the underlying issues in this request, as the minutes of all meetings are treated as strictly confidential and not for publication. I will write again as soon as I can.

I am sorry to trouble you again, but there are two or three other matters I wanted to raise in connection with the MCA submission to the Select Committee on Public Administration. The first relates to item 10 in the Committee questionnaire, and to your response: "MCA policy is for only a senior official - for example a member of the MCA Board not involved in the original decision - or the Department of Health's Policy Management Unit (PMU) to conduct appeals against a refusal to disclose information."

The implication here is that appeals against non-disclosure would routinely be handled by someone other than the person who was the subject of the complaint arising from non-disclosure. This does not appear to have happened in my case, but have I missed something?

Briefly, I wrote to Dr Keith Jones, with a formal Code request, on 16th January. He replied on 6th February, and asked me to contact him if I had any queries. He also indicated I should write to him if "unhappy" about his decision. I was, and wrote on 11th February to say so.

Apart from a cryptic remark "in the first instance" - which I suppose could mean that Dr Jones would pass on my complaint to another reviewer - there was no indication I could get the decision independently reviewed, but every indication I would not.

Could someone please let me know what is going on and, if the matter is now in the hands of an independent reviewer, who the reviewer is and how they were selected?

27. I wrote to you on 25 March with information about Dr Munro who is conducting your appeal against a decision earlier this year of the MCA not to disclose information to you. Dr Munro is the Head of the MCA's Inspection and Enforcement Division and a member of the MCA Board. He had no dealings with the original decision. I will reply on the outcome of that review as soon as I can.

Could you also please send me a copy of the document used by senior MCA staff when conducting reviews, the PMU Internal Review Guidelines on handling appeals?

28. A copy of the Department of Health's Policy Management Unit's Guidelines for conducting internal reviews of decisions to withhold information under the Code of Practice is attached.

I also note from the MCA response to Q10 that the Agency received requests for two such appeals in 1997. May I please ask if either of these two appeals involved Social Audit?

29. Neither appeal against a refusal to disclose information in 1997 concerned Social Audit Ltd. However, in 1998, we have received one appeal and one complaint from you concerning two separate decisions we have made not to release information.

Secondly, I want to question the Agency response to Q 11, in which you discuss the development of the MCA website. Please could you tell me if the developments you mention to the Select Committee are essentially the same as those described as follows, in the National Inventory Project:

Full title: Medicines Control Agency World Wide Web
Summary: The construction of Internet world wide web pages giving information about the Medicines Control Agency to the general public and industry via the CCTA's Open Government server.
Objectives: Publicity
Benefits: Uptake of services
Technical aspects: Web space of CCTA server
Expected cost: Unavailable
Target Groups: Health Care Providers, Private Sector
Partners: CCTA

Assuming this is a description of the project you mentioned to the Select Committee, I hope they decide to make further enquiries, given the principal objective is "publicity", the costs unknown, and benefits so ill-defined. What does "uptake of services" really mean, beyond a count of website 'hits'?

For my part, I would appreciate an explanation of why the "target groups" are described as "Health Care Providers, Private Sector" when the purpose is said to be to give "information about the MCA to the general public and industry".

I would also like to suggest the MCA seriously considers opening up part its website for public discussion - ie inviting public comment, also publishing all comments so as to promote discussion. I am sure this would help to check, test and stimulate the MCA's work. You may know that the Dr. David Clark, Chancellor of the Duchy of Lancaster, recently used the Internet very constructively in this way, even involving himself in Q&A sessions on the White Paper on Freedom of Information, via the UK Citizens' Online Democracy website.

I am again sending this letter, with copies of the correspondence mentioned, to the Clerk to the Select Committee on Public Administration. In the meantime, thank you for your consideration, and I look forward to hearing from you.

30. You asked about the MCA Website entry on the National Inventory Project (NIP) database which is managed by the Central Computer and Telecommunications Agency (CCTA) (The Government Centre for Information Systems). Its aim is to provide an inventory of information sources as well as some technical details about projects so that other organisations thinking of setting up a project themselves can find out if anyone else has done anything similar. Anyone may ask CCTA for their information project to be included in the database.

31. We provided NIP with the particular entry you quote. This was intended to describe what was primarily a pilot site to establish a presence on the Web, to make information about the MCA and what it does available to a wider audience (hence the "publicity" entry) and to demonstrate its potential as an electronic publishing medium. Subsequently, the objectives of our site have developed to include both general and more specifically targeted information (e.g. our site now includes the regular safety bulletin Current Problems in Pharmacovigilance, "Dear Doctor" Letters, information about monitoring of new drugs on the market and drug withdrawal notices.) These are targeted at health care professionals and the pharmaceutical industry, though clearly the general public and other interests such as academics and the media may also find the information it contains useful. Now that we are well past the initial pilot phase, I quite agree that the particular MCA entry is out of date and we shall be providing CCTA with a revised text shortly. I fully expect our site to continue to develop in the years ahead.

32. Thank you for your suggestion of an on-line discussion site. At present we have no plans to introduce one to our website but will consider this further as policy on access to information develops.

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