Increasing Use Of Dangerous Opiates

The request was partially successful.

Dear Medicines and Healthcare products Regulatory Agency,

I would be grateful if you could suply the following information. How many MA’s were held for: -
1. Fentanyl,
2. Fentanyl Citrate,
3. Buprenorphine
4. Naloxone
When the phased withdrawal for Co-proxamol was first announced in January 2005?

How many MA’s were held in January 2017?

How many MA’s for the drugs listed have been cancelled or withdrawn during the period 2005 and 2017?

What was the monetary Gain to MHRA between January 2005 and 2017 resulting from the additional number of MA's issued for these drugs?

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 17/356
        
Dear James Kelly,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
        
Thank you for your enquiry which we received on 9 August 2017.
       
We 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 Customer Services, Medicines and Healthcare products Regulatory Agency

Dear Mr Kelly,
       
Thank you for your FOI request.

Please can you explain the phrase ‘monetary gain’ so that we can assist
with your enquiry.

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][email address]
Stay connected: [2]mhra.gov.uk/stayconnected

 

 

 

 

Dear MHRA Customer Services,
Re: - ‘Monetary Gain’
The difference between the numbers of MA’s held in January 2005 subtracted from the Number of MA’s held in January 2017 for the drugs that are mentioned.
How much money has MHRA gained from the additional MA’s issued during this period?

Yours sincerely,

James Kelly

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,
 
Thank you for your enquiry to the Medicines and Healthcare products
Regulatory Agency. This automated response confirms that we have received
your email and that it will be dealt with as quickly as possible.
 
You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer. We endeavour to
respond to requests within the Department of Health’s target response time
of 18 working days, or 20 working days if your request is a Freedom of
Information request.
 
Our website contains a wealth of information which may assist with your
enquiry. Some of our popular pages are:
 
Clinical trials of medicines and Clinical investigation for a medical
device:
 
[1]https://www.gov.uk/medicines-medical-dev...
       
Manufacturer’s and wholesale dealer’s licences:

[2]https://www.gov.uk/apply-for-manufacture...
 
Registration of medical devices, opticians and dental laboratories:

[3]https://www.gov.uk/register-as-a-manufac...
 
Reporting a problem with a medicine or medical device:

[4]https://www.gov.uk/report-problem-medici...
 
Deciding if your product is a medicine or a medical device:

[5]https://www.gov.uk/decide-if-your-produc...
 
Reporting a counterfeit medical product:
 
[6]https://yellowcard.mhra.gov.uk/counterfe...
 
We are continuously looking to make improvements to the service offered by
our Customer Services team, so if you have any feedback please don’t
hesitate to get in touch with us either on the number below or by
completing the form at the link below:
[7]https://www.surveymonkey.com/s/MHRACusto...
 
If you have not heard from us after 18 working days then please contact us
on 020 3080 6000.
 
Kind regards
 
The Customer Services Team
Communications division
Medicines and Healthcare products Regulatory Agency
 
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [8][MHRA request email]
 
Please note this is an automated reply; please do not respond to this
message.
 
 

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Dear Mr Kelly
 
Thank you for your information request, dated 9 August and clarified on 15
August, where you asked for the numbers of marketing authorisations (MAs)
for specific substances and the monetary gain from any newly granted MAs
for these substances.
 
I can confirm that the MHRA can provide some of the information that you
have requested. The information we can provide is concerning the number of
MAs at certain dates, as follows:
 

* FENTANYL (including fentanyl citrate):  92 MAs currently granted at 1
Jan 2017; 19 at 1 Jan 2005; 9 cancelled after 1/1/05

 

* BUPRENORPHINE:  103 MAs currently granted at 1 Jan 2017, 18 at 1 Jan
2005; 12 cancelled after 1/1/05

 

* NALOXONE:  35 MAs currently granted at 1 Jan 2017, 11 at 1 Jan 2005;
14 cancelled after 1/1/05

 
The question regarding 'monetary gain' is exempt under Section 12 of the
Freedom of Information Act (unreasonable use of resources) and we cannot
process your request any further on that question.
 
Section 12 of the Act allows public authorities to refuse requests where
the cost of dealing with them would exceed the appropriate limit, which
for central government is set at £600. This represents the estimated cost
of one person spending 24 working hours in determining whether the
department holds the information, locating, retrieving and extracting the
information. We consider that Section 12 applies in this instance because
of the complexity of fees and the number of licences involved. We are not
able to provide an estimated figure, nor is it ‘information held’ by the
agency as defined in the Act. Please note that substantially similar
requests made within 60 working days of an original request can be
aggregated into one for the purposes of calculating a cost limit, meaning
that Section 12 could still apply.
We would also like to clarify that when using the term ‘monetary gain’, it
should be noted that the MHRA operates as a Trading Fund and as such our
surplus income is strictly controlled and audited. The following text from
Her Majesty’s Treasury explains the legal background and our current
limits:
 

 1. Section 4(1) of the Government Trading Funds Act 1973 (“the 1973 Act”)
provides that a trading fund established under the Act shall be under
the control and management of the responsible Minister and, in the
discharge of his function in relation to the fund, it shall be his
duty:

        a. to manage the funded operations so that the revenue of the
fund:
                (i) consists principally of receipts in respect of goods
or services provided in the course of the funded operations; and
                (ii) is not less than sufficient, taking one year with
another, to meet outgoings which are properly chargeable to revenue
account; and b. to achieve such further financial objectives as the  
        Treasury may from time to time, by minute laid before the House of
Commons, indicate as having been determined by the responsible Minister
(with Treasury concurrence) to be desirable of        achievement.
 

 2. The Trading Fund for the Medicines and Healthcare Products Regulatory
Agency was established on 1 April 2003 under the Medicines and
Healthcare Products Regulatory Agency Trading Fund Order 2003 (SI 2003
No. 1076).

 

 3. The Secretary of State for Health, being the responsible Minister for
the purposes of section 4(1)(a) of the 1973 Act, has determined (with
Treasury concurrence) that a further financial objective desirable of
achievement by the Medicines and Healthcare Products Regulatory Agency
Trading Fund for the five-year period from 1 April 2013 to 31 March
2018 shall be to achieve a return, averaged over the period as a
whole, of at least 3.5% in the form of a surplus on ordinary
activities before interest (payable and receivable) and dividends
expressed as a percentage of average capital employed. Capital
employed shall consist of the capital (PDC and long-term element of
loans) and Reserves.

 

 4. This minute supersedes that dated 27 March 2008.

 
Let a copy of this Minute be laid before the House of Commons pursuant to
section 4(1)(b) of the Government Trading Funds Act 1973.
 
You can also download a copy of our Annual Report and Accounts for 2016/17
here:
[1]https://www.gov.uk/government/publicatio...
 
If you disagree with how we have interpreted the Freedom of Information
Act 2000 with regards to your request, you can ask for the decision to be
reviewed. The review would be carried out by a senior member of the Agency
who was not involved with the original decision.
 
If you have a query about the information provided, please reply to this
email.
 
Yours sincerely
 
Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [2][email address]
Stay connected: [3]mhra.gov.uk/stayconnected
 
 
 
 
 

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 'Increasing Use Of Dangerous Opiates'.

Fortunately I can estimate the amount the additional 184 MA’s will generate as it will be similar to the increase in revenue for the 138 additional MA’s you issued for Oxycodone which I calculated to be: -

Number of additional MA’s issued for Oxycodone since the ban of Co-proxamol was first announced.

MHRA Total Gains up to 2015.
Additional Application Fees (MA's issued) £1,550,000.00
Subsequent licence variations and service fees (first 60). £1,068,399.00 *
Additional Licence Variation and service Fees (78)
[Average of first 60] £1,388,868.00 **
Total Gain £4,007,267.00

*This Figure is only for the first 60 MA’s issued! There was an additional 138 Ma’s issued for Oxycodone between 2005 and 2015 and many more for other analgesics!

** Average Cost £17806 per MA 138 – 60 = 78 remaining MA’s £1,388,868.00

As Naloxone is used to treat a narcotic overdose in emergency situations the additional 24 MA’s issued would indicate that the alternate analgesics are more dangerous than Co-proxamol and MHRA have gained financially from the additional opiates dispensed and the cure for overdose.

Number of additional MA’s issued since the ban of Co-proxamol was first announced.

FENTANYL +75
BUPRENORPHINE +85
NALOXONE +24
Total 184

I’m sure someone in the organisation would have known exactly how much their financial gain was worth or certainly have been able to supply reasonable estimates for my FOI requests.

My reasoning: -

Your reply to my FOI request FOI 16/451 Re: Monetary impact of Co-proxamol withdrawal

What was the monetary loss to MHRA when these MA’s were cancelled? Zero

What was the potential monetary loss to MHRA between 2008 and 2015?
Licence Variations and Renewals Etc.) This has been calculated to be
approximately £100,000

How many MA’s were held for the following drugs when the
phased withdrawal for Co-proxamol was first announced in January 2005?
Codeine, Co-codamol, Dihydrocodeine, and Tramadol 389 (288 for any
codeine or dihydrocodeine containing products and 101 tramadol products)

How many MA’s were held in January 2015? 285 – (186 for codeine or dihydrocodeine + 99 for tramadol)

What was the monetary Gain to MHRA between 2008 and 2015 resulting from any increases in the number of MA's issued? (Including Variations and Renewals Etc.).

(There was a net decrease in numbers of MAs during this period). Zero.

Following this response I made a further request FOI 16/459, your reply: -

How many MA’s were held for OXYCODONE drugs when the phased withdrawal for Co-proxamol was first announced in January 2005? 13

How many MA’s were held in January 2015? 151

(Information From)
FDA EXECUTIVE SUMMARY (December 20th 2005)
DRUG ABUSE AND DEPENDENCE SUMMARY OF AERS DATA.

The highest number of all adverse events was reported for Oxycodone followed by Tramadol, according to this FDA report produced between 1969 and 2005 there were 10671 more adverse event reports, 3256 more overdose reports, 437 more suicide reports, 5041 more abuse & dependence reports, and the total number of death reports increased by 5059 when Oxycodone was compared with Propoxyphene (Co-proxamol)!

Oxycodone was prescribed more than a million times in England (2012 – 2013), a rise of 39 per cent since 2010.

OXYCODONE PRESCRIPTIONS
2009/2010 - 788,607 2010/2011 - 919,177 2011/2012 - 1.01million 2012/2013 - 1.09million
The Number of ‘Death Reports’ caused by Tramadol rose from 53 in 2005 to 240 in 2014. Following advice from ACMD Tramadol became a ‘Schedule 3’ controlled drug on 10th June 2014.

MHRA REFUSED TO RECOMMEND CONTROLLED STATUS FOR CO-PROXAMOL DURING 2005!

The UK suicide rates were already declining for Co-proxamol while the drug was classed as a POM prior to the ban.

Suicide/Open reports had reduced from 296 in 2000 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’. I feel sure if the classification had been changed to controlled Co-proxamol would have remained on the market today at a very completive price for the NHS!

Remuneration and pension interests of the thirteen most senior managers at MHRA range from £105,000 to £210,000

It would be obvious to assume MHRA couldn’t afford to pay the exorbitant salaries from drugs which could only generate a low income.

This was certainly the case with Co-proxamol its financial contribution to MHRA would have declined to a total of just one hundred thousand pounds between 2005 and 2015!

Dr Ian Hudson Chief Executive
2016 Salary, Performance pay, and Pension related benefits amounted to a total of £220,000 - £225000!

Dr June Raine, CBE Director of Vigilance & Risk Management of Medicines 2016 Salary, Performance pay, and Pension related benefits amounted to a total of £165.000 - £170,000!

Following my previous FOI requests [FOI 16/546 FOI 17/046] I wasn’t surprised when you invoked ‘Section 12 of the Freedom of Information Act’ regarding my question 'monetary gain'.

Fortunately I can assume the additional 184 MA’s would generate a similar increase in revenue to the 138 additional MA’s you issued for Oxycodone which I calculate to be a further £4,000,000 +.

As Naloxone is used to treat a narcotic overdose in emergency situations the additional 24 MA’s issued would indicate that the alternate analgesics are more dangerous than Co-proxamol and MHRA have gained financially from the additional opiates dispensed and the cure for overdose.

It remains my firm belief that MHRA often uses ‘Section 12 of the Freedom of Information Act’ in order to avoid any embarrassing questions which would show them in a negative way.

I'm sure someone in the organisation would have known exactly how much their financial gain was worth or certainly have been able to supply reasonable estimates to my FOI requests without invoking ‘Section 12’.

Yours faithfully,

James Kelly

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,
 
Thank you for your enquiry to the Medicines and Healthcare products
Regulatory Agency. This automated response confirms that we have received
your email and that it will be dealt with as quickly as possible.
 
You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer. We endeavour to
respond to requests within the Department of Health’s target response time
of 18 working days, or 20 working days if your request is a Freedom of
Information request.
 
Our website contains a wealth of information which may assist with your
enquiry. Some of our popular pages are:
 
Clinical trials of medicines and Clinical investigation for a medical
device:
 
[1]https://www.gov.uk/medicines-medical-dev...
       
Manufacturer’s and wholesale dealer’s licences:

[2]https://www.gov.uk/apply-for-manufacture...
 
Registration of medical devices, opticians and dental laboratories:

[3]https://www.gov.uk/register-as-a-manufac...
 
Reporting a problem with a medicine or medical device:

[4]https://www.gov.uk/report-problem-medici...
 
Deciding if your product is a medicine or a medical device:

[5]https://www.gov.uk/decide-if-your-produc...
 
Reporting a counterfeit medical product:
 
[6]https://yellowcard.mhra.gov.uk/counterfe...
 
We are continuously looking to make improvements to the service offered by
our Customer Services team, so if you have any feedback please don’t
hesitate to get in touch with us either on the number below or by
completing the form at the link below:
[7]https://www.surveymonkey.com/s/MHRACusto...
 
If you have not heard from us after 18 working days then please contact us
on 020 3080 6000.
 
Kind regards
 
The Customer Services Team
Communications division
Medicines and Healthcare products Regulatory Agency
 
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [8][MHRA request email]
 
Please note this is an automated reply; please do not respond to this
message.
 
 

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

1 Attachment

Dear James Kelly,
       
Thank you for your email.

Please find attached your response.
      
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

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