Freedom of Information request (FOI 22/854)
Published 17 January 2024
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FOI 22/854
25th August 2022
Dear
Thank you for your email of 28 July 2022, in which you requested the following:
鈥淨uestion 1
a. Please may you provide the sales information for TOTAL WEIGHT听in kilograms听of oral isotretinoin products supplied to the NHS for each of the following years:
i. 2021 ii. 2020 iii. 2019 iv. 2018 v. 2017 vi. 2016 vii. 2015 viii. 2014 ix. 2013 x. 2012
b. If it is within the time/cost limit set by the FOI Act, please provide breakdown of total weight听in kilograms of oral isotretinoin products by supplier.
Question 2
Please may you provide the total amount of money received by the MHRA from the below companies for the years 2016 to 2021 inclusive. Where possible, if it is within the time/cost limit set by the FOI Act, please听may you provide a breakdown of why the money was paid to the MHRA.
- Roche Products Ltd, and subsidiaries thereof.
- A A H Pharmaceuticals Ltd,听and subsidiaries thereof
- Ennogen Healthcare Ltd,听and subsidiaries thereof.
- Sigma Pharmaceuticals Plc,听and subsidiaries thereof.
- Stiefel Laboratories (UK) Ltd,听and subsidiaries thereof.
- Sun Pharmaceutical Industries Europe B.V.,听and subsidiaries thereof.
I would like this information returned in an email.鈥�
We are handling your request under the Freedom of Information Act (the Act).
Question 1
We do hold some information within the scope of your request. However, the information which we do hold has been obtained via a commercial database, Midas. In handling your request we have considered whether any of the exemptions within the Act apply to what you have requested. We consider that Section 41 (Information Provided in Confidence) and Section 43(2) (Commercial Interests) are both applicable.
Section 41 is an absolute exemption for which we are not required to conduct a public interest test, except to state that we would consider the release of this information to be an actionable breach of confidence. In the case of Section 43(2), this exempts information whose disclosure would, or would be likely to, prejudice the commercial interests of any legal person (an individual, a company, the public authority itself or any other legal entity). We are required to consider the public interest when applying this exemption. In this case we do not believe that there is a public interest in releasing this information when it would damage the commercial interests of the Midas database and its operator, IQVIA, by supplying freely to you information which has been obtained from their commercial database.
In saying this we wish to make two further points:
- You are free to contact Midas to arrange your own access to this information:
- There may be some data which is held and can be made available to you via the NHS Business 天美影院 Authority. We recommend you contact them if you wish to make such a request: . They also make available some data on the prescribing of medicines in secondary care and primary care publicly available.
Question 2
We hold information in scope of your request, but we are unable to supply some of what you have requested as set out below.
In the table below you will find data which goes back to 2017, rather than 2016 as requested. 2016/2017 was the year we transitioned from our old Enterprise Resource Planning system to system which we are currently using. 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 拢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. Extracting data for 2016 from our old system would involve a significant amount of manual effort to retrieve and extract information in scope of your request, which we estimate would exceed the 24 working hours permitted under the Act. For this reason we are exempting under Section 12 the information you have requested for 2016.
In the usual course of handling a request where we have identified that Section 12 will exempt some information, our usual process is to contact the requestor to explain the position and request a refinement of the request. In this instance the only refinement we would be able to suggest is for you to request the data from 2017, for the reasons given. In order to comply with the timeframes outlined in the Act we have proceeded with your request on that basis, but please note this does not prevent you challenging our use of Section 12 should you wish to do so.
The data from 2017 onwards is presented in the table below. Please note the following:
- The MHRA levies fees on the pharmaceutical industry in relation to services provided, and regulatory functions carried out, by the MHRA in relation to medicinal products for human use (for example, medicines licence applications, scientific advice meetings or clinical trial applications). The fees charged are set out in secondary legislation through Parliament.
- We do not keep data about subsidiaries or any other element of the corporate structure of our customers. Key words were used to identify related customers where possible.
- You requested 鈥榓 breakdown of why the money was paid鈥�. We have added a 鈥楶urpose of payment鈥� column into this table, which lists the description of the payments from our Chart of Accounts; please note the data covers all payments, not just those which relate to Isotretinoin. You may also find the details of our fees as published on gov.uk helpful when reviewing this table.
- We were not able to locate any payments from a Stiefel Laboratories in this timeframe.
| Keyword | Customer Name | Purpose of Payment | 2017/18 | 2018/19 | 2019/20 | 2020/21 | 2021/22 | Grand Total |
|---|---|---|---|---|---|---|---|---|
| AAH | AAH PHARMACEUTICALS LIMITED | GDP Inspections | 11,616.00 | 3,872.00 | 3,872.00 | 3,872.00 | 1,936.00 | 25,168.00 |
| 听 | 听 | GMP Inspections | 听 | 听 | 2,655.00 | 听 | 听 | 2,655.00 |
| 听 | 听 | ML/WDL Variations | 972.00 | 1,229.00 | 486.00 | 1,229.00 | 1,486.00 | 5,402.00 |
| 听 | 听 | Periodic Fees | 听 | 576.00 | 576.00 | 576.00 | 576.00 | 2,304.00 |
| Ennogen | ENNOGEN HEALTHCARE LIMITED | Complex Applications | 听 | 51,286.00 | 25,643.00 | 51,286.00 | 128,215.00 | 256,430.00 |
| 听 | 听 | CPRD Data | 听 | 听 | 听 | 30,000.00 | 听 | 30,000.00 |
| 听 | 听 | Export Certificates | 340.00 | 68.00 | 136.00 | 听 | 440.00 | 984.00 |
| 听 | 听 | Falsified Medicines Directive | 听 | 3,157.00 | 听 | 听 | 听 | 3,157.00 |
| 听 | 听 | GDP Inspections | 听 | 听 | 听 | 听 | 7,744.00 | 7,744.00 |
| 听 | 听 | GMP Inspections | 4,240.83 | 13,784.36 | 11,500.40 | 听 | 7,246.00 | 36,771.59 |
| 听 | 听 | Group Variations | 1,866.00 | 9,643.70 | 16,978.00 | 13,731.00 | 6,113.00 | 48,331.70 |
| 听 | 听 | Inspection Expenses | 1,621.42 | 6,977.75 | 3,135.60 | 听 | 听 | 11,734.77 |
| 听 | 听 | Labels/Leaflets | 8,436.00 | 23,172.00 | 14,497.00 | 21,137.00 | 28,492.40 | 95,734.40 |
| 听 | 听 | ML/WDL Variations | 771.00 | 2,542.00 | 2,570.00 | 514.00 | 3,187.00 | 9,584.00 |
| 听 | 听 | Periodic Fees | 听 | 118,004.00 | 151,245.00 | 161,826.00 | 172,023.00 | 603,098.00 |
| 听 | 听 | PL/PLPI Change of Address | 442.00 | 884.00 | 884.00 | 10,608.00 | 3,094.00 | 15,912.00 |
| 听 | 听 | PLPI Applications | 26,342.40 | 36,736.00 | 听 | 听 | 听 | 63,078.40 |
| 听 | 听 | PLPI Variations | 35.70 | 2,891.70 | 8,211.00 | 3,570.00 | 28,209.00 | 42,917.40 |
| 听 | 听 | Product Licence Reclassifications | 听 | 听 | 听 | 277.00 | 听 | 277.00 |
| 听 | 听 | Product Licence Variations | 7,026.40 | 13,375.00 | 12,069.00 | 19,709.70 | 7,983.00 | 60,163.10 |
| 听 | 听 | Simple Applications | 2,564.00 | 听 | 听 | 2,564.00 | 听 | 5,128.00 |
| 听 | 听 | Standard Applications | 听 | 18,804.00 | 听 | 9,402.00 | 9,402.00 | 37,608.00 |
| 听 | 听 | Unlicensed Imported Medicines | 听 | 2,077.00 | 10,383.00 | 10,383.00 | 25,957.00 | 48,800.00 |
| 听 | ENNOGEN LIMITED | Pharmacovigilance | 听 | 听 | 听 | 听 | 7,965.00 | 7,965.00 |
| Roche | F HOFFMANN-LA ROCHE LIMITED | Clinical Trials Applications | 听 | 听 | 9,180.00 | 听 | 听 | 9,180.00 |
| 听 | 听 | Clinical Trials Variations | 听 | 听 | 900.00 | 1,125.00 | 450.00 | 2,475.00 |
| 听 | F. Hoffmann-La Roche AG | Sales of Goods & Products | 听 | 听 | 听 | 听 | 3,775.00 | 3,775.00 |
| 听 | Genentech Inc. | CPRD Observationals | 320,000.00 | 听 | 750,000.00 | 656,250.00 | 375,000.00 | 2,101,250.00 |
| 听 | 听 | Miscellaneous Income | 听 | 5.05 | 48.00 | 48.00 | 48.00 | 149.05 |
| 听 | 听 | Sales of Goods & Products | 听 | 听 | 684.00 | 378.00 | 1,257.00 | 2,319.00 |
| 听 | Roche Chile Ltda. (CL) | Miscellaneous Income | 48.00 | 48.00 | 听 | 听 | 听 | 96.00 |
| 听 | 听 | Sales of Goods & Products | 190.00 | 228.00 | 听 | 听 | 听 | 418.00 |
| 听 | ROCHE DIABETES CARE GMBH | Clinical Investigations | 听 | 3,820.00 | 听 | 听 | 听 | 3,820.00 |
| 听 | Roche Diagnostica Brasil Ltda | Sales of Goods & Products | 听 | 听 | 595.00 | 听 | 听 | 595.00 |
| 听 | Roche Diagnostics (HK) Ltd | Miscellaneous Income | 听 | 48.00 | 听 | 听 | 听 | 48.00 |
| 听 | 听 | Sales of Goods & Products | 1,881.00 | 114.00 | 听 | 听 | 听 | 1,995.00 |
| 听 | Roche Diagnostics Belgium | Miscellaneous Income | 48.00 | 听 | 听 | 听 | 听 | 48.00 |
| 听 | 听 | Sales of Goods & Products | 109.00 | 听 | 听 | 听 | 听 | 109.00 |
| 听 | Roche Diagnostics GmbH | Miscellaneous Income | 768.00 | 1,104.00 | 576.00 | 912.00 | 听 | 3,360.00 |
| 听 | 听 | Sales of Goods & Products | 14,568.00 | 105,334.00 | 23,826.00 | 23,447.74 | 72,480.00 | 239,655.74 |
| 听 | Roche Diagnostics International Ltd | Miscellaneous Income | 48.00 | 听 | 48.00 | 144.00 | 听 | 240.00 |
| 听 | 听 | Sales of Goods & Products | 5,886.00 | 3,608.00 | 2,622.00 | 4,889.00 | 2,614.00 | 19,619.00 |
| 听 | Roche Diagnostics Ltd | Miscellaneous Income | 听 | 48.00 | 听 | 听 | 听 | 48.00 |
| 听 | 听 | Sales of Goods & Products | 1,015.00 | 342.00 | 听 | 1,354.00 | 731.00 | 3,442.00 |
| 听 | Roche Diagnostics Poland Sp.z.o.o. | Miscellaneous Income | 听 | 听 | 48.00 | 48.00 | 听 | 96.00 |
| 听 | 听 | Sales of Goods & Products | 听 | 听 | 120.00 | 126.00 | 172.00 | 418.00 |
| 听 | Roche Diagnostics Rus LLC | Sales of Goods & Products | 听 | 听 | 听 | 2,034.00 | 4,036.00 | 6,070.00 |
| 听 | Roche Diagnostics S.L | Sales of Goods & Products | 听 | 416.00 | 334.00 | 220.00 | 听 | 970.00 |
| 听 | Roche Diagnostics SpA | Miscellaneous Income | 听 | 48.00 | 听 | 听 | 听 | 48.00 |
| 听 | 听 | Sales of Goods & Products | 听 | 114.00 | 听 | 听 | 听 | 114.00 |
| 听 | Roche Diagnostics Turkey A.S | Miscellaneous Income | 听 | 听 | 96.00 | 96.00 | 听 | 192.00 |
| 听 | 听 | Sales of Goods & Products | 27,552.00 | 20,189.00 | 187,370.00 | 152,168.00 | 199,360.00 | 586,639.00 |
| 听 | Roche Diagnostics UK Ltd | Miscellaneous Income | 听 | 33.20 | 听 | 听 | 听 | 33.20 |
| 听 | 听 | Sales of Goods & Products | 15,095.00 | 13,310.80 | 9,883.00 | 6,528.00 | 6,686.00 | 51,502.80 |
| 听 | Roche Lietuva, UAB | Sales of Goods & Products | 听 | 1,506.00 | 听 | 听 | 1,292.00 | 2,798.00 |
| 听 | Roche Molecular Systems, Inc. | Miscellaneous Income | 48.00 | 听 | 96.00 | 192.00 | 听 | 336.00 |
| 听 | 听 | Sales of Goods & Products | 5,519.00 | 5,070.00 | 4,038.00 | 5,338.00 | 4,936.00 | 24,901.00 |
| 听 | ROCHE PALO ALTO | EAM PIM Meeting | 听 | 听 | 49,509.00 | 听 | 听 | 49,509.00 |
| 听 | ROCHE PRODUCTS LIMITED | Clinical Trials Applications | 64,260.00 | 76,500.00 | 55,080.00 | 156,060.00 | 79,785.00 | 431,685.00 |
| 听 | 听 | Clinical Trials Variations | 13,275.00 | 54,900.00 | 45,675.00 | 61,560.00 | 76,275.00 | 251,685.00 |
| 听 | 听 | Company Meetings | 听 | 3,624.00 | 听 | 听 | 7,214.00 | 10,838.00 |
| 听 | 听 | EAM PIM Meeting | 听 | 30,053.00 | 11,933.00 | 37,576.00 | 3,624.00 | 83,186.00 |
| 听 | 听 | Export Certificates | 204.00 | 204.00 | 听 | 听 | 1,216.00 | 1,624.00 |
| 听 | 听 | Falsified Medicines Directive | 听 | 514.00 | 听 | 514.00 | 257.00 | 1,285.00 |
| 听 | 听 | GCP Inspections | 听 | 听 | 30,811.50 | 3,726.00 | 听 | 34,537.50 |
| 听 | 听 | GMP Inspections | 听 | 听 | 听 | 2,655.00 | 931.50 | 3,586.50 |
| 听 | 听 | Group Variations | 7,062.00 | 4,406.20 | 10,246.70 | 1,555.00 | 23,158.50 | 46,428.40 |
| 听 | 听 | Homeopathic Applications | 听 | 听 | 听 | 听 | 704.00 | 704.00 |
| 听 | 听 | Labels/Leaflets | 1,853.00 | 5,393.00 | 1,893.00 | 2,092.00 | 6,257.00 | 17,488.00 |
| 听 | 听 | Major Applications | 听 | 听 | 听 | 18,437.00 | 111,190.00 | 129,627.00 |
| 听 | 听 | Miscellaneous Income | 听 | 听 | 听 | 听 | 3,624.00 | 3,624.00 |
| 听 | 听 | ML/WDL Variations | 486.00 | 2,000.00 | 1,900.00 | 2,313.00 | 2,000.00 | 8,699.00 |
| 听 | 听 | Periodic Fees | 听 | 87,896.00 | 75,756.00 | 45,390.00 | 255,935.00 | 464,977.00 |
| 听 | 听 | Periodic Safety Update Reports | 听 | 听 | 听 | 890.00 | 16,020.00 | 16,910.00 |
| 听 | 听 | Pharmacovigilance | 听 | 39,825.00 | 听 | 听 | 听 | 39,825.00 |
| 听 | 听 | Product Licence Variations | 7,675.70 | 1,982.00 | 10,812.70 | 7,334.50 | 79,591.70 | 107,396.60 |
| 听 | 听 | RAMAXL | 听 | 15,500.00 | 15,500.00 | 15,500.00 | 15,500.00 | 62,000.00 |
| 听 | 听 | Renewals | 听 | 听 | 听 | 听 | 2,241.00 | 2,241.00 |
| 听 | 听 | Unlicensed Imported Medicines | 听 | 519.00 | 130.00 | 130.00 | 2,077.00 | 2,856.00 |
| 听 | ROCHE REGISTRATION LIMITED | EMA Inspections | 听 | 3,060.00 | 听 | 听 | 听 | 3,060.00 |
| 听 | 听 | Periodic Fees | 听 | 听 | 听 | 听 | -457.00 | -457.00 |
| Sigma | SIGMA PHARMACEUTICALS PLC | Export Certificates | 听 | 68.00 | 听 | 听 | 听 | 68.00 |
| 听 | 听 | Falsified Medicines Directive | 听 | 3,157.00 | 257.00 | 514.00 | 514.00 | 4,442.00 |
| 听 | 听 | GDP Inspections | 1,936.00 | 听 | 7,744.00 | 听 | 听 | 9,680.00 |
| 听 | 听 | GMP Inspections | 听 | 5,310.00 | 听 | 听 | 听 | 5,310.00 |
| 听 | 听 | ML/WDL Variations | 486.00 | 615.00 | 1,715.00 | 486.00 | 972.00 | 4,274.00 |
| 听 | 听 | Periodic Fees | 听 | 576.00 | 576.00 | 576.00 | 576.00 | 2,304.00 |
| 听 | 听 | Unlicensed Imported Medicines | 听 | 519.00 | 130.00 | 听 | 听 | 649.00 |
| Sun | SUN PHARMA UK LIMITED | Decentralised Applications Incoming (CMS) | 听 | 听 | 107,524.00 | 听 | 听 | 107,524.00 |
| 听 | 听 | Export Certificates | 听 | 476.00 | 听 | 听 | 68.00 | 544.00 |
| 听 | 听 | Group Variations | 4,315.00 | 8,314.00 | 10,875.00 | 听 | 听 | 23,504.00 |
| 听 | 听 | Homeopathic Applications | 听 | 704.00 | 听 | 听 | 听 | 704.00 |
| 听 | 听 | Labels/Leaflets | 777.00 | 11,863.00 | 2,192.00 | 听 | 听 | 14,832.00 |
| 听 | 听 | ML/WDL Variations | 听 | 听 | 486.00 | 听 | 257.00 | 743.00 |
| 听 | 听 | Periodic Fees | 听 | 156,906.00 | 128,100.00 | 听 | 听 | 285,006.00 |
| 听 | 听 | Product Licence Reclassifications | 听 | 277.00 | 听 | 听 | 听 | 277.00 |
| 听 | 听 | Product Licence Variations | 8,916.00 | 14,765.00 | 12,368.00 | 听 | 971.00 | 37,020.00 |
| 听 | SUN PHARMACEUTICAL INDUSTRIES EUROPE BV | Company Meetings | 听 | 2,763.00 | 5,526.00 | 听 | 听 | 8,289.00 |
| 听 | 听 | Complex Applications | 听 | 听 | 听 | 听 | 25,643.00 | 25,643.00 |
| 听 | 听 | Decentralised Applications Incoming (CMS) | 137,826.00 | 54,061.00 | 124,242.00 | 217,938.00 | 听 | 534,067.00 |
| 听 | 听 | Export Certificates | 听 | 听 | 476.00 | 听 | 听 | 476.00 |
| 听 | 听 | Group Variations | 3,082.00 | 1,244.00 | 8,474.00 | 14,811.00 | 5,701.00 | 33,312.00 |
| 听 | 听 | Labels/Leaflets | 704.00 | 13,032.00 | 9,917.00 | 7,937.00 | 6,390.00 | 37,980.00 |
| 听 | 听 | Periodic Fees | 听 | 135,042.00 | 240,123.00 | 249,364.00 | 364,625.00 | 989,154.00 |
| 听 | 听 | Periodic Safety Update Reports | 听 | 听 | 听 | 445.00 | 听 | 445.00 |
| 听 | 听 | Pharmacovigilance | 听 | 听 | 听 | 听 | 21,240.00 | 21,240.00 |
| 听 | 听 | Product Licence Variations | 11,228.00 | 9,959.00 | 11,460.00 | 13,520.40 | 14,359.10 | 60,526.50 |
| 听 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | Inspection Expenses | 9,750.00 | 13,000.00 | 听 | 听 | 听 | 22,750.00 |
| 听 | 听 | GCP Inspections | 26,550.00 | 听 | 听 | 听 | 听 | 26,550.00 |
| 听 | 听 | GMP Inspections | 听 | 23,895.00 | 听 | 听 | 听 | 23,895.00 |
| 听 | 听 | Sales of Goods & Products | 听 | 听 | 1,200.00 | 1,260.00 | 7,840.00 | 10,300.00 |
| Grand Total | 听 | 听 | 759,434.45 | 1,247,387.76 | 2,237,936.90 | 2,058,566.34 | 2,249,205.20 | 8,552,530.65 |
We hope you find this information helpful.
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 will 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 and please remember to quote the reference number above in any future communications.
If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:
Information Commissioner鈥檚 Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Yours sincerely
MHRA Customer Experience Centre