Mr J Perrott
20 Greenacre Court
Lancaster
LA1 4LE
Date: 4th February 2011
Dear Mr Perrott
Subject: Formal Complaint (our ref: CC0067)
Reference: Formal Complaint regarding Dr June Raine and responses to questions and issues concerning Ativan and generic lorazepam licences.
I am writing now in full response to your letter dated 11/01/2011 concerning a complaint about Dr June Raine’s handling of your enquiries and questions concerning Ativan, generic Lorazepam licences and their record management.
The main elements of your complaint are as follows:
1. Dr Raine provided you with inaccurate information concerning the MHRA’s record management and although referred to searches done for specific files, no such documentation has been disclosed and questions concerning what was found remain unanswered.
2. In relation to the licensing of generic lorazepam licences the MHRA have stated on different occasions two different directives: Directive 65/65/EC (article 4.8a) and Directive 2001/83/EC used in the approval of licences.
3. Dr Raine concealed the fact that the MHRA routinely destroys important safety material and this brings into question any generic drug’s safety by referring back to safety information impossible.
I have now reviewed the background to this issue, and also looked at relevant correspondence. The result of my investigation is as follows:
Record Keeping
1. The MHRA has had its own records management policy since at least 1993 – prior to that it was subject to Department of Health retention and destruction policies. At the time of your original request last July, Dr Raine was correct in explaining the Agency’s policy on records management and that as standard practice, all documents relating to a licence application would be reviewed 5 years after it had been cancelled or withdrawn with a view to destroying the paperwork. Also, being bound by Public Records Act, records are not kept forever unless they are likely to be of subsequent public interest, in which case they are transferred to The National Archive (TNA) for release after 30 years. She also stated that we did not hold any records of Ativan prior to 1981.
2. Over the past year, the Agency reviewed its records management policy. A revised policy was formally approved by the Agency’s Executive Board in September 2010 and has since been implemented. The revision of the policy came about because of a number of factors, including a decision by the Information Commissioner in 2009. This decision was linked to the Agency’s inherited legacy records. As you can imagine, methods of recording archived material and personnel managing those records have changed over the years since the late 1960s and early 70s when medicines were still regulated as part of the Department of Health. Some of the records are held on spreadsheets but only from around the 1980s, prior to that we have had to rely on some very old paperwork. Some of this is disintegrating as Dr Raine has said and the handwritten notes are not always clear. The paper records are often poorly indexed compared to today’s records, whilst some records are marked as having been destroyed, there is often no date attached, and it is becoming less reliable in searching for very old data. In addition, where very old data boxes have been found, sometimes some of the contents are missing where assessors in past years have requested the data and then not returned it to the archive. There was also a significant amount of paperwork retained in the archive which was more than 30 years old and which we are not allowed, under the Public Records Acts, to retain. We have had much more robust arrangements in place for managing paper archived material for a number of years now, including the recording of destruction dates, so this is not a continuing problem. (The paper archive is no longer being added to since the implementation of the Agency’s new IT system, Sentinel, some years ago now.)
3. The new policy has the approval of TNA, and was developed in the light of how products are monitored and updated once they are on the market. The Agency’s Executive Board (EB) agreed that data would only be retained for 15 years in future, regardless of whether or not the products were still on the market. For all other documentation relating to all work across the Agency the dates for retention range from 1 year to 15 years depending on the nature of the records and the business need. There are exceptions to the rules and these include all committee papers, which are retained by the Agency for 25 years and which are all being transferred, in due course, to TNA once they reach 30 years. There they will be available for public viewing. There are other exceptions for retaining records longer and decisions on these are made on a case by case basis. These may include specific drug safety data and other issues of importance that will be retained for longer specified periods and reviewed with a view to whether or not they should be retained for the public interest and thus eventually referred to TNA.
4. In the meantime work has continued to implement the new policy and archived material that comes within the relevant dates for destruction, and which cannot be identified as needing to be retained for longer, is included in the destruction programme underway. The EB accepted that, in some cases, this might mean that certain documentation which exceptionally might have been retained for longer may fall within the destruction exercise because it cannot be identified. Our Minister is aware of this risk but this exercise will bring our archive to a standard that is better fit for purpose and comes within the terms of the Public Records Acts.
5. In relation to the Agency’s search for documentation, searches have been made within the paper archive and the electronic filing system. We have informed you that we hold no records prior to 1981. This is correct although we did find a handwritten reference in a very old index record that Ativan had been through the Committee on Safety of Drugs (CSD) in 1974. We no longer hold the records for the CSD for this time and so are unable to determine at what meeting this would have been considered, but the CSD records, papers, agendas and minutes are now held in TNA. Some of these records – where they are over 30 years old – have already been released for public viewing at TNA along with records of other medicines advisory committee meetings. These include the Committee on the Review of Medicines (CRM) which ran from 1975 – 1978 and which reviewed all products on the market (including Ativan I understand) when the Medicines Act came into force. You may be able to find records of the original consideration of Ativan in these files. I believe the files series at the NA are BN117 for the CRM and MH171 for the CSD.
6. Further searches have been made for more information, for example any documentation within the Agency relating to the benzodiazepine litigation but the Agency was not directly involved in that case and no files were found. Had any further records been found, the Agency would have informed you. There is no evidence that I can find that documentation that you have asked for has been found and withheld from you.
Licensing of generic lorazepam – Directives
7. Dr Raine’s e-mail to you of 12th January clarifies the two Directives which you mention, explaining that the Directive 65/65/EC reference was used before it was superseded by the 2001/83/EC Directive. Depending on when applications were made, they would have been made under either one or the other. I trust that this has now clarified this particular issue.
Timeliness of responses
8. I understand that your last enquiry of 9th December has now been answered in an e-mail dated 12th January 2011. This was 24 working days – four of which included the Christmas Bank Holidays. We would generally aim for 20 working days for replies to correspondence in line with the period for Freedom of Information requirements. You have not detailed any other specific enquiries that have received late replies but we should, at the least let you know if there is likely to be a delay beyond 20 working days in making a response.
Concealing information
9. You assert that Dr Raine has concealed the fact that the MHRA routinely destroys important safety document and that there is no record of what is destroyed and when. As a public body subject to the Public Records Act, we are obliged to have a disposition schedule in place for the routine disposal -either through destruction or extended retention- for all records reaching the end of their useful life, as determined by legal, regulatory or business need. We are unable to retain records forever. However, the Agency does not routinely destroy important safety documents. The policy we have is designed to protect important safety information and other documents whilst destroying, at a reasonable time, all remaining documentation and records we have. We are also required to identify records that would be of the public interest and ensure the transfer of these records to TNA for future retention once they reach 30 years. All of the medicines advisory committee papers will eventually be available for public scrutiny in TNA and the committee papers relating to the period when Ativan would have been considered by the CRM and the CSD should both now be available for you to view there. The committee papers are considered an important record for seeing the more important issues that have been considered in this area of regulation over the years.
10. The Agency would never deliberately and routinely destroy important records. Many of the records relating to the work of regulating medicines go back to the late 1960s and early 1970s. The Department of Health was responsible for medicines regulation until 1991 when the Medicines Control Agency was created. We became the MHRA in 2003 when we merged with the Medical Devices Agency. Record keeping methods have changed significantly over the years and been recorded and handled in many different ways during that time. It is inevitable that there will be some gaps in knowledge, particularly for the much older records, and whilst this is regrettable it is, unfortunately, a limitation we have to live with.
Conclusion
11. I do not uphold your complaint that Dr Raine gave you incorrect information regarding the Agency’s records management policy for the reasons given in paragraph 2 above.
12. The issue concerning the two different Directives being used for licensing generic products has now, I believe, been clarified in Dr Raine’s e-mail to you of 12th January 2011.
13. We aim in most instances to respond to correspondence within 20 working days. We should alert correspondents if we are unlikely to be able to meet that deadline.
14. I cannot uphold your assertion that Dr Raine “concealed ..that the MHRA routinely destroys important information”. As explained in paragraph 9 and 10 above, the Agency takes its responsibilities for records management extremely seriously. Unfortunately our ability to track accurately the whereabouts of all the information ever received in relation to applications is limited by the state and accuracy of our legacy archive and indexing systems which span over 60 years of technology.
15. Finally, you e-mailed me on 22nd January regarding a question to Dr Raine to which you had a response on 12th January. You had asked previously how 26 generic licences had been granted between 1981 and 1993 as they were issued prior to Dir 2001/83/EC allowing ‘bridging’?’. She has answered that they were granted under Dir 65/65/EC. She did not deliberately intend to confuse you in her previous answer but had accidentally and automatically referred to the latest Directive for abridged applications. It was a simple error for which I apologise on her behalf.
I trust that you feel that your complaint has been seriously dealt with and your concerns adequately addressed. Should this not be the case however you should write to me again and ask for a review to be carried out by either our Chief Executive or the Independent Complaints Adviser.
Yours sincerely
Sue Jones
Central Complaints Manager
Head of Corporate Policy Unit
MHRA