Did MHRA Benefit From The Ban On Co-proxamol?

The request was successful.

Dear Medicines and Healthcare products Regulatory Agency,
Re your last response: -
I found your last response both tardy and entirely unsatisfactory and feel committed to apply for a new FOI request in order to finally receive the information I require.

My original complaint was submitted to MHRA on 3rd July 2017 and a response didn’t arrive until 11th December 2017.

1) Please could you supply copies of all the correspondence and dates of any telephone calls between ICO, PHSO, and MHRA between 3rd July and 11th December 2017 regarding my complaint?

Re: -
http://news.bbc.co.uk/1/hi/health/422182...
Painkiller scrapped over suicides. Last Updated: Monday, 31 January, 2005, 09:56 GMT
“There is no need for panic or concern” (Chairman of the CSM Professor Gordon Duff)

The drug has been linked with suicides.
A popular painkiller is being withdrawn from the UK market over concerns about links with suicide.
Co-proxamol, used by thousands for conditions such as back pain, will be phased out over the next year or two.

People do not need to come off the drug yet, and should discuss their treatment with their GP, said the Medicines and Healthcare products Regulatory Agency.

Charities criticised the move saying it left many patients with very few options of effective pain relief.
____________________

There were 1.75 million patients being forced to try the alternate analgesia during 2005 and up to four recommendations (steps) each patient had to complete. This would have equated to a maximum of seven million additional GP appointments! This resulted in hundreds of thousands of patients being forced off Co-proxamol without the opportunity of a discussion with their GP! (I was informed by telephone by the surgery’s Pharmacist).

2) Please could you supply copies of all the information MHRA and CSM sent out to GP’s and other health professionals regarding any prescribing recommendations during 2005?

____________________
Re: -
http://web.archive.org/web/2017080109142.......

Professor Gordon Duff Chairman Committee on-Safety of Medicines Contacted the FDA Directly on 31st January 2005 [Reference: CEMICMOl2005/2] ‘WITHDRAWAL OF CO-PROXAMOL PRODUCTS AND INTERIM UPDATED PRESCRIBING INFORMATION’

3) Please can you explain why CSM felt it necessary to inform the FDA on their ill-informed findings six months before it was debated in parliament?

____________________

Hansard https://publications.parliament.uk/pa/cm...

Re: -
13 Jul 2005: Column 941 [Para 3]
4) CSM had given five options for MHRA to consider, why did MHRA not disclose the other four options to Government during 2005?
____________________

5) Did MHRA inform Ministers in 2005 that CSM’s call for evidence had an extremely low response?
____________________

‘Public call for evidence on the risks and benefits of co-proxamol’
No patients were directly contacted by MHRA!
354 organisations were contacted by the MHRA, and just 52 responded!
15 replies were for the ban
13 replies were against the ban.
22 replies had no overall opinion about the ban
WITH A RESPONSE OF JUST 14.7%, THESE RESULTS WERE HARDLY FIT FOR RECOMENDING A BAN ON CO-PROXAMOL!
6a) Please could you supply any evidence that hundreds of thousands of patients wouldn’t suffer any ill effects from the start of the ban (1st January 2008)?

6b) Please could you supply copies of all documents pertaining to CSM’s‘Rigorous Review’ which would be of benefit to patients or reduce costs to the NHS?

6c) Please could you supply copies of all the correspondence with Government Ministers relating to the poor response to CSM’s ‘public call for evidence on the risks and benefits of co-proxamol’.
____________________

RE: - https://publications.parliament.uk/pa/cm...

17th Jan 2007: Column 341WH. [Para 2] Re: - “That paper lists a complete ban as only one of five options.” The Medicines and Healthcare products Regulatory Agency said that it decided in favour of a full ban because information and communication programmes had failed to alert prescribers and patients of the dangers of the drug. What the paper presented to the committee actually said was that the programmes had failed at national level as they had “been piecemeal activities rather than a concerted campaign using several vehicles simultaneously.”

7a) Please can you explain why MHRA chose the BAN option when suicide rates had been decreasing between 1999 and 2004? [Attachment 4]
7b) Please could supply all documents relating to MHRA’s decision to dismiss the other four options suggested by CSM?
____________________

[17 Jan 2007: Column 344WH Paragraphs 6 to 11] “Ministers and the MHRA would do well to take heed of what the president of the British Society for Rheumatology, Dr. Andrew Bamji” said on the matter……

Re: - “Schedule 3 status would also send a clear message that co-proxamol is not a first-line drug and that it should be used only after careful consideration of all the available alternatives.”

8a) Please could you supply copies of all correspondence between MHRA and Government Ministers regarding MHRA’s decision not to recommend controlled status for Co-proxamol?

8b) Please could you inform me which Ministers responded, and supply all correspondence between Ministers and MHRA regarding a reconsideration of your decision to ban?
____________________

https://www.ncbi.nlm.nih.gov/pmc/article...
Re: -
“There is no robust evidence that efficacy of this combination product is superior to full strength paracetamol alone in either acute or chronic use.

Hanks Forbes report published during 1998 challenged this, stating it was very effective in ‘Palliative Care’.

India was the last country to ban Co- proxamol along with its production during 2013. It wasn’t a surprise when this resulted in the collapse of their palliative care system and the decision was overturned very quickly! Propoxyphene products are now back in production.

The situation in India corroborates beyond any doubt that the Hanks Forbes report was 100% correct on the efficacy of Co-proxamol!

9) Please could you supply all the information MHRA used which led you to dismiss this extremely relevant report?
____________________

Re: -
“It has not been possible to identify any patient group in whom the risk: benefit may be positive.
(Hansard) [17 Jan 2007: Column 341WH]

“However, an article in an issue of Pulse magazine from October last year—a copy of which was thrust under my nose by my brother, who happens to be a GP—had the headline “GPs demand U-turn on co-proxamol ban”. The magazine reported its own survey, which showed that 70 per cent of GPs and 94 per cent of rheumatologists demanded that the MHRA revisit its decision.

Although the spokesman for the MHRA accepted that there was “a small group of patients with a clinical need for co-proxamol as alternatives appear not to be effective or suitable,” he said that the licence for the drug would still be withdrawn in December 2007.

10) Please could you supply all the information MHRA considered before rejecting the views of the majority of GP’s and Rheumatologists in the ‘Pulse Report’, and your reasons why?

Re: -
Question and Answer Document Co-proxamol: Outcome of the review of risks and benefits

http://pad.res360.net/Content/Documents/...

Q1
What was the outcome of the review of the use of co-proxamol and request for information on risk: benefit? The CSM, the independent expert body which advises the government on medicines, has considered the responses to the public request for further information on the risks and benefits of co-proxamol. After careful consideration, the CSM has advised that co-proxamol should be withdrawn from the market on the grounds that the benefits of taking co-proxamol are not considered to outweigh the risks.

11) [Page 2 Paragraph 3 Above] States CSM offered five options, and it was MHRA who advised that co-proxamol should be withdrawn from the market. Please could you clarify?

Q2
If co-proxamol has been available for over 40 years, why has action only been taken now?
Co-proxamol has been marketed since the 1960's, and was firmly established as a treatment for mild to moderate pain before modern standards of clinical research. Current evidence is that previous advice in 1985 to strengthen warnings about co-proxamol overdose has not impacted on the problem.

12) Please could you supply any evidence that shows suicides weren’t reducing 1999 to 2004?

The UK suicide rates were already declining for Co-proxamol while the drug was classed as a POM prior to the ban. [Page 2 Q7 above] Suicide/Open reports had reduced from 298 in 1999 to just 204 in 2004 a 7% REDUCTION HAD BEEN ACHEIVED! Further reductions could have been guaranteed by simply changing the drug classification to ‘controlled’.

13) Please supply copies of all the documents MHRA reviewed when they concluded that “current evidence is that previous advice in 1985 to strengthen warnings about co- proxamol overdose has not impacted on the problem.” [Attachment 4] clearly shows a 7% reduction in Co-proxamol suicides prior to the ban being announced!
____________________

Since the announcement of the ban on Co-proxamol (2005) MHRA have issued an additional 298 Marketing Authorisations for three of the far more dangerous opiates; Oxycodone, Fentanyl, and Buprenorphine.

The number of patients admitted to Hospital for opioid poisoning have risen year on year since 2005 (the year the ban was announced) There were 4,891 admissions in 2005-06 reaching a peak of 12,254 in 2013, 7363 additional admissions!
As MHRA increased the number of Marketing Authorisations deaths in the UK from all of the additional analgesia has increased alarmingly since the MA’s for Co-proxamol were removed! [Attachment 2]
The UK government were forced to impose a ‘controlled status’ on Tramadol during June 2014 as a result of the ever increasing death toll!

In the attached image ‘FDA EXECUTIVE SUMMARY December 20th 2005’ which was available two years before the ban you can clearly see that Co-proxamol was a safe drug when compared with Oxycodone, and Tramadol? [Attachment 3]
____________________

RE: -
Co-proxamol by all CCGs https://openprescribing.net/measure/copr...

Why it matters: The licence for co-proxamol (paracetamol 325mg, dextropropoxyphene HCl 32.5mg) was withdrawn, due to a lack of evidence of additional benefit compared with full-dose paracetamol and concerns about toxicity in overdose. Although co-proxamol has been unlicensed since 2007, and the number of prescriptions has significantly dwindled since then, it is still available as an unlicensed product for those patients who have found it difficult to have a suitable alternative analgesic.
However, the price for co-proxamol has increased significantly recently, with some suppliers charging £300 for 100 tablets. We estimate that the NHS will spend £9m a year on approximately 56 thousand prescriptions, compared with £10m in 2004 for 7.2 million prescriptions.
• This has resulted in 7.44 million patients in the UK without the best pain relief!
• Has left the NHS eight million pounds worse off due to the prescription price rises.
• There are additional higher costs for the alternate inferior medications to consider, and the additional prescriptions GP's have had to issue to counter the horrendous side effects patients have had to suffer. There are also the additional 7363 Hospital admissions for opioid poisoning between 2005 and 2013!
____________________
RE: -
During August 2016 I began to realise there may be a different reason or motive for MHRA to ban Co-proxamol so on 15th August 2016 I applied for a FOI request (Ref: FOI 16/451). ‘Loss of Co-proxamol Leads To A Life Of Relentless Side Effects, And Substandard Pain Relief!’
A further request was submitted on 28th August 2016 (Ref: FOI 16/459)
I clarified my request on 6th October 2016. You responded on 17th October 2016, and I requested an internal review on 20th October. This was acknowledged with a different reference number (Ref: FOI 16/546).
I received your response to the internal review on 14th November 2016.
Following a response from ICO a further FOI was requested ‘Refined Request Re: - FOI 16/451 / 16/459 / 16/546 on 10th March 2017
I received your response on 9th February 2017 (FOI 17/046)
A further FOI was requested on 9th August 2017 ‘Increasing Use of Dangerous Opiates’
Internal review requested 8th September 2017
After reviewing all the information I had received through my FOI requests I felt confident that I would be able to calculate a reasonable ‘guestimate’ on the financial gain for MHRA.

MHRA Total Gains up to 2015 Additional MA's issued for Oxycodone, Fentanyl, and Buprenorphine [Attachment 5]
____________________
It appears that MHRA are EIGHT MILLION POUNDS BETTER OFF following the additional 298 MA’s you have issued since 2005 for Oxycodone, Fentanyl, and Buprenorphine!

14) Please could you supply any evidence that would contradict my guestimate?

Yours faithfully,

James Kelly

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 18/197

Dear Mr James Kelly,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 23 April 2018.

I confirm that your request is being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.

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Dear MHRA Customer Services,
Ref: FOI 18/197
Please can you inform me why this request has been delayed?

Yours sincerely,

James Kelly

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

FOI 18/197

Dear Mr Kelly,
       
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FOI 18/197

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FOI 18/197

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FOI 18/197

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Dear Medicines and Healthcare products Regulatory Agency,

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request an internal review of Medicines and Healthcare products Regulatory Agency's handling of my FOI request 'Did MHRA Benefit From The Ban On Co-proxamol?'.

You will be fully aware I have been in contact with various departments In the DOH, NHS, and MHRA since June 2008. Much of the information you have supplied in your latest response was already known to me. I will send a PDF file separately later showing the situation from the patents perspective. [Co-proxamol A Patients Point of View]

There are always two sides to every situation this is my response to your response to my FOI Request: -

1) Copies of all the correspondence and dates of any telephone calls between ICO, PHSO, and MHRA between 3rd July and 11th December 2017 regarding my complaint?

I find it difficult to believe that you failed to respond to my official complaint dated 03rd July 2017 by late November.

Within weeks of my contact with PHSO a response from MHRA was received on 11th Dec 2017.
(I don’t think this was just a coincidence, and your response was totally irrelevant to the complaint)!

Why was my complaint ignored for five Months?

2) Copies of all the information MHRA and CSM sent out to GP’s and other health professionals regarding any prescribing recommendations during 2005?

The only document I could find on the internet was CSM Letter to GP’s 31/01/2005. [Page 5 Four Steps]
https://assets.publishing.service.gov.uk...

Was this the only Document?

This document MHRA and CSM recommended that patients should discuss their treatment with their healthcare professional as published at the website given above. All information that was sent to GPs and other health professionals is published on the internet.

There were 1.75 million patients being forced to try the alternate analgesia during 2005 and 2006, they were forced to participate in the four recommendations set out in the ‘CSM letter to Doctors: -

Class I – Acute pain either as acute self-limiting episode or on a background of chronic pain: e.g. soft tissue injuries, post-operative pain, osteoarthritis, low back pain, dysmenorrhoea.

Step 1: Paracetamol Step 2: Substitute ibuprofen Step 3: Add Paracetamol to Ibuprofen Step 4: Continue paracetamol and replace ibuprofen with an alternative NSAID

This equated to a maximum of seven million additional GP appointments! This resulted in hundreds of thousands of patients being forced off Co-proxamol without the opportunity of a discussion with their GP! (I was informed by telephone by the surgery’s Pharmacist).

Did MHRA Honestly Believe That Seven Million Additional GP Appointments Would Be Available?

3) Please can you explain why CSM felt it necessary to inform the FDA on their ill-informed findings six months before it was debated in parliament?

The FDA dismissed this warning on two occasions prior to its final removal on Nov 19th 2010. FDA finally succumbed to the pressures from ‘Public Citizen’ by a very small majority of 14 to 12. This petition relied heavily on the lies and misinformation supplied by MHRA, and EMA.

FDA stated the situation in the UK was completely different to the USA as DXP had always been a controlled drug and this wasn’t’ the case in the UK! (I have no doubt it should have been)

Why did MHRA Not follow the advice from MP Howard Stoat during the Parliamentary debate (17th January 2007)? “A more sensible way forward, as my hon. Friend said, is to make co-proxamol a controlled drug under schedule 3 of the Misuse of Drugs Act 1971. The advantage of doing that is that the potential risks involved in prescribing would be flagged up, but GPs could still prescribe the drug when necessary, and it would be clearly acknowledged in doctors' minds that extra precautions and closer monitoring of patients would be advisable.

Schedule 3 status would also send a clear message that co-proxamol is not a first-line drug and that it should be used only after careful consideration of all the available alternatives it.” would also give pharmacists the opportunity to reinforce guidance to patients who are on the drug and to ensure that they fully understand the risks and benefits of taking it.

Why has MHRA never explained why Schedule 3 status was not an option? Schedule 3 status was forced on Tramadol during June 2014 when the deaths from Tramadol poisoning (240) had reached the same level as Co-proxamol in 2005 (242).

4) CSM had given five options for MHRA to consider, why did MHRA not disclose the other four options to Government during 2005?

[Hansard 17 Jan 2007: Column 341WH]

I have a copy of the paper considered by the Committee on Safety of Medicines in reaching its decision; an individual requested one under freedom of information legislation. That paper lists a complete ban as only one of five options. The Medicines and Healthcare products Regulatory Agency said that it decided in favour of a full ban because information and communication programmes had failed to alert prescribers and patients of the dangers of the drug. What the paper presented to the committee actually said was that the programmes had failed at national level as they had “been piecemeal activities rather than a concerted campaign using several vehicles simultaneously.”

The paper goes further in its conclusions, saying that “It is possible on pharmacokinetic grounds that co-proxamol may only have a full therapeutic effect with chronic dosing. There may therefore be some justification for co-proxamol remaining a therapeutic option for the management of chronic pain.”
Another conclusion in the paper, on the clinical effectiveness of co-proxamol, was based on the contention that there were no robust data to prove that. Co-proxamol is an old drug that has been around since the 1950s. It has never been subject to testing to find out exactly how it works, as is done on modern drugs. Such testing has not been carried out even today. There are no robust data, because there are no data.
The conclusion drawn could quite easily have been the opposite—that there were no robust data, and that that proved that the drug was not effective. There are no robust data proving that full-strength paracetamol is as effective as co-proxamol either. From my experience, it most certainly is not.
Despite my extensive searching on the internet I can’t locate this CSM document which contains the other four options
If this document is now archived I think you should have supplied the document or a link to it.

5) Did MHRA inform Ministers in 2005 that CSM’s call for evidence had an extremely low response?

As The Government of the day appeared to have a poor understanding of the term ‘Due Diligence’ Does MHRA think a response of just 14.7% to CSM’s ‘call for evidence’ was sufficient evidence to call for a complete ban on Co-proxamol?

8b) Please could you inform me which Ministers responded, and supply all correspondence between Ministers and MHRA regarding a reconsideration of your decision to ban? We are unable to identify any correspondence between ministers and the MHRA on this subject from our electronic archives. The market authorisation Holders were able to appeal to the decision and CSM took on board their responses to CSM’s concerns. Therefore, the decision was reconsidered, however the concerns of CSM were not addressed, and therefore the decision to withdraw Coproxamol licences was retained. The historical documentation concerning all decisions are attached.

In a previous response I received from MHRA the names of the ‘Market Authorisation Holders’ who appealed the decision had been redacted.

Why did MHRA feel that this was necessary?

Your response
Confidential information is redacted from the documents under FOI Act section 41 – Personal Information - – information is exempt if it contains personal data which would identify a living person. Confidential information is also redacted from the documents under FOI Act section 43 – commercial interests - this exempts information where disclosure would be likely to prejudice the commercial interests of any person. It also includes a specific exemption for trade secrets.

I feel sure the ‘Market Authorisation Holders’ would have welcomed their names being published as it appears that MHRA have removed their MA’s for no good reason and they have suffered unnecessary financial losses!

Your responses to all my remaining questions appear to be no more than fudge when you consider the facts: -

Co-proxamol is effective in chronic pain!

https://www.ncbi.nlm.nih.gov/pmc/article...

Hanks Forbes report published during 1998 challenged this, stating Co-proxamol was very effective in ‘Palliative Care’.

If it was proved that it was effective for end of life pain, it would be an exceptionally effective drug for arthritic pain! (Which it was)

The situation in India during 2013 corroborates beyond any doubt that the Hanks Forbes report was 100% correct on the efficacy of Co-proxamol, and MHRA was completely wrong!

India was the last country to ban Co- proxamol and its production during 2013. It wasn’t a surprise when this resulted in the collapse of their palliative care system and the decision was overturned very quickly!

Co-proxamol was the most effective analgesic in the UK for over 50 years prior to 2005! It has been available for import from India since February 2017 for an approximate cost of £3.00! If the drug was imported it would become the most effective, safest, and cheapest analgesic available for the NHS!

Dextropropoxyphene combination - Price List of 94 Brands Price List Updated on February 2nd 2017
https://www.medindia.net/drug-price/dext...

It has not been possible to identify any patient group….. Another Blatant Lie!

https://publications.parliament.uk/pa/cm...

(Hansard) 17 Jan 2007: Column 341WH— “However, an article in an issue of Pulse magazine from October last year—a copy of which was thrust under my nose by my brother, who happens to be a GP—had the headline “GPs demand U-turn on co-proxamol ban”. The magazine reported its own survey, which showed that 70 per cent of GPs and 94 per cent of rheumatologists demanded that the MHRA revisit its decision.

Although the spokesman for the MHRA accepted that there was “a small group of patients with a clinical need for co-proxamol as alternatives appear not to be effective or suitable,” he said that the licence for the drug would still be withdrawn in December 2007.

MHRA chose to ignore all the relevant advice supplied in the two ‘Parliamentary Debates’ presented by MP Anne Begg!

Caroline Flint: I know that in the past my hon. Friend has asked questions about the prescription of alternatives to co-proxamol. At that time, the Minister of State, Department of Health, my right hon. Friend the Member for Doncaster, Central (Ms Winterton), said that the guidance provided refers to a number of alternatives that can be used. The chief medical officer has communicated that to health care professionals, too. In particular, we have provided advice on the withdrawal of co-proxamol and the alternatives that should be considered. *Despite the withdrawal, we have an inbuilt flexibility to continue to prescribe in certain circumstances for people for whom co-proxamol seems to be the only answer.

* THERE WASN’T ANY INBUILT FLEXIBILITY FOR THE HUNDREDS OF THOUSANDS OF PATIENTS WHOSE GP’s WOULDN’T DEFY THEIR UNION OR INSURERS AND REFUSED TO CONTINUE PRESCRIBING SINCE 1st JANUARY 2008! (I CONSIDER MY SELF EXTREMELY LUCKY AS I WAS CLASSED AS A ‘NAMED PATIENT’ FOLLOWING A TWO YEAR PEIOD WITHOUT THE DRUG DURING 2005 – 2008) My prescription was finally removed on 11/11/2015!

[ GIVE DETAILS ABOUT YOUR COMPLAINT HERE ]

A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/d...

Yours faithfully,

James Kelly

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 18/324
       
Dear Mr Kelly,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
       
Thank you for your enquiry which we received on 8 June 2018.
       
I confirm that your request is being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.
       
Kind Regards,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [email address]
Stay connected: mhra.gov.uk/stayconnected

show quoted sections

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

1 Attachment

FOI 18/324
 
Dear Mr Kelly,
 
Thank you for your email.
 
Please find attached the response to your FOI request below.
 
Kind Regards,
 
Customer Services
Communications division
Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [1][MHRA request email]
Stay connected: mhra.gov.uk/stayconnected
 

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

1 Attachment

FOI 18/197

Dear Mr Kelly,

Thank you for your email.

Please find attached the response to your Internal review.

Kind Regards,

Customer Services
Communications division
Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected: mhra.gov.uk/stayconnected

show quoted sections

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

3 Attachments

Dear Mr Kelly,

 

Please see the attached letter which explains our review of the data
previously provided to you in relation to FOI 18/197 which has resulted in
us removing the redactions relating to the details of the marketing
authorisation holders. Given the size of these documents, the updated
files are being sent within three emails which should be labelled in the
subject box.

 

Kind regards

 

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London  E14 4PU

Telephone: 020 3080 6000
Email: [1][MHRA request email]
[2]Stay connected

 

show quoted sections

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

1 Attachment

Dear Mr Kelly,

 

Please find attached 2 of 3 email.

 

Kind Regards

 

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London  E14 4PU

Telephone: 020 3080 6000
Email: [1][MHRA request email]
[2]Stay connected

 

show quoted sections

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

4 Attachments

Dear Mr Kelly,

 

Please find attached 3 of 3 email.

 

Kind Regards

 

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London  E14 4PU

Telephone: 020 3080 6000
Email: [1][MHRA request email]
[2]Stay connected

 

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James Kelly left an annotation ()

All questions finally answered during June 2019 following the ICO Decision Notice issued 23 May 2019

Reference: FS50796228
1
Freedom of Information Act 2000 (FOIA)
Decision notice
Date: 23 May 2019
Public Authority: Medicines and Healthcare Products
Regulatory Agency
Address: 10 South Colonnade
Canary Wharf
London
E14 4PU
Complainant: James Kelly
Address: KJRJim@aol.com
Decision (including any steps ordered)
1. The complainant has requested information from the Medicines and Healthcare Products Regulatory Agency (MHRA) about the importation of Co-proxamol. The MHRA disclosed the information under parts 1 and 2 of the request and also some of the information under part 3 but applied section 41 (Information provided in confidence) and 43 (Commercial interest) of the FOIA to withhold the names of the licenced importers.
2. The Commissioner’s decision is that the MHRA has not sufficiently demonstrated that section 41 or 43 of the FOIA is engaged in relation to the information that has been withheld under part 3 of the request.
3. The Commissioner requires the public authority to take the following steps to ensure compliance with the legislation.
 Disclose the names of the licensed importers of Co-proxamol.
4. The public authority must take these steps within 35 calendar days of the date of this Decision Notice. Failure to comply may result in the Commissioner making written certification of this fact to the High Court pursuant to section 54 of the Act and may be dealt with as a contempt of court.
Reference: FS50796228
2
Request and response
5. On 19 August 2018, the complainant wrote to MHRA and requested information in the following terms:
“1) How many countries supplied Co-proxamol to the UK from 1st January 2007 to the date of this request?
2) The name and country of the companies who manufactured and supplied Co-proxamol to the UK from 1st January 2007 to the date of this request?
3) The number and names of all licensed UK importers of Co-proxamol from 1st November 2015 to the date of this request?”
6. On 4 September 2018 the MHRA responded. In regard to part 1 of the request, it said it had applied section 43 of the FOIA to withhold this information. In regard to parts 2 and 3 of the request, it said it had disclosed the information in the attachment accompanying the response.
7. On 12 October 2018 the MHRA conducted a review and wrote to the complainant maintaining its position. The review however refers to section 43 of the FOIA being applied to withhold the information under part 3 and not part 1 of the request.
Scope of the case
8. On 24 October 2018 the complainant contacted the Commissioner to complain about the way his request for information had been handled.
9. During the course of the Commissioner’s investigation the MHRA has confirmed that it has disclosed all the information requested under parts 1 and 2 of the request. It has since also released the number of licenced importers of Co-proxamol requested under part 3 of the request, and has applied section 41 and 43 of the FOIA to withhold the names of the licenced importers.
Reference: FS50796228
3
10. The Commissioner has considered whether the MHRA has correctly applied section 41 and/or 43 of the FOIA to withhold the names of the licenced importers of Co-proxamol under part 3 of the request.
Reasons for decision
Section 41 of the FOIA – Information provided in confidence
11. Section 41 of the FOIA provides that information is exempt from disclosure if it was provided to a public authority by another person and disclosing it would be an ‘actionable’ breach of confidence (e.g., the aggrieved party would have the right to take the authority to court as a result of the disclosure).
Was the information provided by another person?
12. The MHRA has explained that under the Human Medicines Regulations 2012 (the Regulations) unlicensed medicines (Co-proxamol) being purchased to be supplied to another person (clinics, Trusts etc) must be imported via a licenced importer that holds a Wholesale Dealers Licence. It said that the withheld information was obtained by it because Schedule 4 of the Regulations requires importers to complete a notification form giving prescribed particulars, including; the importer’s name, medicine, manufacturer (supplier), manufacturing country etc when notifying the MHRA of an intended import for a client in the UK. The Commissioner is satisfied that the information was therefore provided by another person.
Would disclosure constitute an actionable breach of confidence?
13. In considering whether disclosure of information constitutes an actionable breach of confidence the Commissioner will consider the following:
 whether the information has the necessary quality of confidence;
• whether the information was imparted in circumstances importing
an obligation of confidence; and
• whether disclosure would be an unauthorised use of the
information to the detriment of the confider.
Reference: FS50796228
4
Does the information have the necessary quality of confidence?
14. Information will have the necessary quality of confidence if it is more than trivial and if it is not otherwise accessible.
15. The Commissioner notes the complainant’s view that since becoming an unlicensed medicine the price of Co-proxamol has risen in recent years and is concerned about the cost implications on the NHS meaning that it can no longer afford to prescribe the medication to patients. The Commissioner has reviewed the withheld information and notes it is only held by the MHRA because of the requirement of Schedule 4 of the Regulations. She has seen no evidence that the withheld information has been put in the public domain. The Commissioner has therefore determined that the information is not trivial and is satisfied that it would only be accessible by the MHRA.
Was the information imparted in circumstances importing an obligation of confidence?
16. Even if information is to be regarded as confidential, a breach of confidence will not be actionable if it was not communicated in circumstances that created an obligation of confidence. An obligation of confidence may be expressed explicitly or implicitly.
17. The information was obtained from the importers by the MHRA as a
requirement of the Regulations. The MHRA says its primary aim is to safeguard public health and information provided under statuary provisions which further those aims should not be used for other purposes. The Commissioner is satisfied that the names of the importers can be said to be have been imparted in circumstances importing an implied obligation of confidence, since the information is not trivial, has only been obtained in order to fulfil the MHRA’s statutory duty in relation medicine regulation and would only be accessible by the MHRA.
Detriment to the confider
17. Developments in case law have established that information about individual’s private and personal life can be protected by the law of confidence, even if disclosure would not result in any tangible loss to the confider. If the requested information is commercial in nature then the disclosure will only constitute a breach of confidence if it would have a
Reference: FS50796228
5
detrimental impact on the confider. The authority will be expected to put forward an explicit case for detriment. Usually the detriment to the confider in such cases will be a detriment to the confider’s commercial interests.1
18. The MHRA said that disclosing the withheld information could prejudice the commercial interest of the importers by allowing competitors to gain an advantage in the market resulting in claims being made by the importers against the MHRA. It says that a valuable business asset of importers is their database of customers, suppliers, manufacturers and information about their products. Disclosing the withheld information would enable competitors to link importers to contracts with specific suppliers and by doing this competitors could ascertain what the importers ‘are doing’ and where they are obtaining their supplies.
19. It said that competitors could use this information to go directly to the importers sources and construct deals with suppliers to compete with, undercut and/or disrupt importers. The MHRA said it had previously been made aware of the ‘sensitivities’ of importers about disclosing data relating to their products/suppliers, this has resulted in the MHRA’s quarterly reports no longer identifying what products are being imported by specific importers and products only being identified by their generic and not by brand names. In regard to the complainant’s view about the withheld information informing public debate about the cost of Co-proxamol, the MHRA explained that 2.2 and 2.3 of the MHRA’s Guidance Note 14 makes it clear that the responsibility for the prescription lies with the medical specialist and only the special clinical needs of the patient are taken into account. It said that the cost of the medication is not taken into account when prescribing and the pricing is not in the MHRA’s functions.
20. The Commissioner notes that the name of the unlicensed medicine (Co-proxamol) is stated in the request. She also notes that the MHRA has already disclosed the names of the importer’s suppliers (manufacturers) and the manufacturing countries in response to part 2 of the request. She also notes that conducting a basic internet search of both the importers and suppliers company names locates their company information / websites that mention their pharmaceutical supply services. This information is already in the public domain for any of its competitors to obtain. In the absence of the importers identity, the importers customers and competitors can still use the information already disclosed to contact the importers suppliers directly.
1 https://ico.org.uk/media/for-organisatio...
Reference: FS50796228
6
21. The Commissioner acknowledges the MHRA’s comments about how the information could be used by competitors, she is not however convinced that disclosing the importers names without other specific commercial information about existing importer/supplier relationships, e.g. contracts, price lists, etc that competitors could use to meaningfully inform and impact negotiations will result in competition or disruption to the importers or enable competitors to undercut them.
22. She also notes that information about the identity of the importer’s customers (clinics, Trusts etc) has not been requested, and cannot see how the withheld information could be used by competitors (even if they managed to form relationships with the same suppliers, they do not have access to the importer’s client base) to undercut importers. She also understands that the requirements of the Regulations mean that the importers customers cannot import medicines directly themselves (they must use a licenced importer).
23. The Commissioner further notes that the MHRA has failed to confirm whether any of the importers that raised previous sensitivities about products/suppliers being disclosed are the same as those listed in the withheld information (in regard to Co-proxamol) and what those specific ‘sensitivities’ are, instead it only said it no longer identifies products imported by specific (not all) importers in its quarterly reports. She also notes the requirements set out in 2.2 and 2.3 of Guidance Note 14 and the MHRA’s comments that only the special clinical needs of the patient and not the cost of medicines should be taken into account when prescribing medicines.
24. The Commissioner therefore considers that the MHRA has not provided any tangible evidence that disclosure of the withheld information will cause detriment to the importers’ commercial interests and that the exemption at section 41 of the FOIA has not been engaged. She will now go on to consider the application of section 43 of the FOIA.
Section 43 of the FOIA – Prejudice to commercial interests
25. Section 43 of the FOIA provides that if the disclosure of information would prejudice the commercial interests of any person including the public authority who holds the information, then the information is exempt from disclosure. This is a prejudice-based exemption and is subject to the public interest test.
Reference: FS50796228
7
26. In order for section 43(2) to be engaged the Commissioner considers that three criteria must be met. First, the actual harm that the public authority alleges would, or would be likely, to occur if the withheld information was disclosed has to relate to the applicable interests within the relevant exemption.
27. Second, the public authority must be able to demonstrate that some causal relationship exists between the potential disclosure of the information being withheld and the prejudice which the exemption is designed to protect. Furthermore, the resultant prejudice that is alleged must be real, actual or of substance.
28. Third, it is necessary to establish whether the level of likelihood of prejudice being relied upon by the public authority is met – eg disclosure ‘would be likely’ to result in prejudice or disclosure ‘would’ result in prejudice. In relation to the lower threshold, the Commissioner considers that the chance of prejudice occurring must be more than a hypothetical possibility; rather there must be a real and significant risk. With regard to the higher threshold, in the Commissioner’s view this places a stronger evidential burden on the public authority. The anticipated prejudice must be more likely than not.
29. The MHRA has confirmed that in its view disclosing the names of the importers to the public would (as opposed to would be likely to) prejudice the importers commercial interests.
30. It has then referred the Commissioner to its previous arguments used in support of its application of section 41, namely that disclosure would enable competitors to link the importers to contracts with specific suppliers and in doing so enable them to ascertain ‘what the importers are doing’ and where they are obtaining their supplies. This information would then be used to undercut and/or disrupt importers. In the MHRA’s view disclosing the information would therefore be likely to significantly impact the importers ability to effectively compete with its competitors in the medicines supply market.
31. The Commissioner is of the same view as detailed in paragraphs 21 -23 (above) with regard to section 41, she is not convinced that disclosing the importers names without other specific commercial information about importer/supplier relationships e.g., contracts, price lists, etc that competitors could use to meaningfully inform and impact negotiations will result in competition or disruption to the importers or enable competitors to undercut them. She understands that information about the identity of the importer’s customers (clinics, Trusts etc) has not been requested, and cannot see how the withheld information could be used by competitors (even if they formed relationships with the same
Reference: FS50796228
8
suppliers, they do not have access to the importer’s client base) to undercut importers. She is also mindful that in the absence of the importers names, the identity of the suppliers has already been disclosed and that company information about both the importers and suppliers pharmaceutical supply services is otherwise already available on the internet (on their websites). This information can therefore be used by the importers customers and competitors to contact the suppliers directly in respect of the supply of unlicensed medicines. She also understands that the requirements of the Regulations mean that the importers customers cannot in fact import medicines directly themselves and must use a licenced importer that holds a wholesale dealers licence. She also notes that the MHRA has failed to confirm whether any of the importers that raised previous sensitivities about products/suppliers being disclosed are the same as those listed in the withheld information (in regard to Co-proxamol) and what those specific ‘sensitivities’ are, instead it only said it no longer identifies products imported by specific (not all) importers in its quarterly reports.
32. The Commissioner considers in order for the exemption to be engaged, it must be shown that the disclosure of specific information will result in specific prejudice to one of the parties. In demonstrating prejudice, an explicit link needs to be made between specific elements of withheld information and specific prejudice which disclosure of these elements would cause.
33. The arguments provided do not demonstrate that prejudice to the commercial interests of any party would occur. Therefore the engagement of the exemption falls at the first stage.
34. The Commissioner has concluded that the MHRA has not demonstrated to the required standard that it had correctly engaged the exemption at section 43(2) of the FOIA. Consequently it is not necessary for the Commissioner to consider the public interest test in this case.
Reference: FS50796228
9
Right of appeal
29. Either party has the right to appeal against this Decision Notice to the First-tier Tribunal (Information Rights). Information about the appeals process may be obtained from:
First-tier Tribunal (Information Rights)
GRC & GRP Tribunals,
PO Box 9300,
LEICESTER,
LE1 8DJ
Tel: 0300 1234504
Fax: 0870 739 5836
Email: GRC@hmcts.gsi.gov.uk
Website: www.justice.gov.uk/tribunals/general-reg...
30. If you wish to appeal against a Decision Notice, you can obtain information on how to appeal along with the relevant forms from the Information Tribunal website.
31. Any Notice of Appeal should be served on the Tribunal within 28 (calendar) days of the date on which this Decision Notice is sent.
Andrew White
Group Manager
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

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