FOI release

Freedom of Information request on medicines and the Innovaive Licensing and Access Pathway (FOI 22/555)

Published 27 March 2023

FOI 22/555

10th May 2022

Dear

Thank you for your email.

Regarding your recent request for information under the Freedom of Information (FOI) Act, please see our response to your questions below.

1. Please provide a list of all medicines that have either been awarded or refused the Innovation Passport designation under the Innovative Licensing and Access Pathway (ILAP) since the launch of this process in January 2021, together with details of the rationale for those decisions.

This information is exempt from release under Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of the FOI Act. Section 41 is an absolute exemption and no consideration of the public interest is required, except to state that we would consider the release of this information to be an actionable breach of confidence. Section 43 is a qualified exemption and a consideration of the public interest is required. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm in releasing information on products that have not yet been authorised for use and are still under development. This information can be used by competitors for their commercial advantage. Examples of public interest arguments would be a major public health risk or a major procedural failure or irregularity. Further, the release of this information would inhibit companies from submitting ILAP applications and sharing such information with MHRA, which would be commercially harmful to the industry in general.

2.Please provide copies of any working papers, assessments, internal guidance or review documents on implementation of the ILAP as described in MHRA’s guidance document “Innovative Licensing and Access Pathway” dated 30 March 2021 and updated 24 January 2022 (the ILAP Guidance), specifically in relation to :

a. In relation to the Criterion 1 of the eligibility criteria listed in the ILAP Guidance, the interpretation of “there is a significant patient or public health need” and whether this is limited to clinical needs or, if not, what other types of need would be considered by MHRA;

b. In relation to the Criterion 2 of the eligibility criteria listed in the ILAP Guidance, the interpretation and assessment of i. Innovation; and ii. “aligning with the objectives for UK public health priorities”;

c. In relation to the Criterion 3 of the eligibility criteria listed in the ILAP Guidance, the interpretation of “benefits to patients”, whether these are limited to clinical benefits and, if not, what other types of benefits are considered by MHRA;

Response to a, b & c: Any assessments of ILAP applications received would be exempt from release under Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of the FOI Act. Please see our response to Question 1 for further information on the application of these sections of the FOI Act.

Any working papers, assessments, internal guidance or review documents on the implementation of ILAP would be exempt from disclosure under Section 35 (Formulation of policy) of the FOI Act, specifically Section 35(1)(a). The purpose of this section of the FOI Act is to protect good government and preserve a safe space to consider policy in private. We have considered the public interest in releasing this information, such as the positive effect of having open and transparent government decision making. However, there are reasons for withholding this information, such as the inhibition of the free/frank discussion in the formulation of this policy without harassment or lobbying. It is our decision that the public interest is best served to withhold the information requested.

Any draft internal guidance and Standard Operating Procedures (SOPs) MHRA holds would be consistent with the current advice provided to applicants on the MHRA website on the ILAP process and the application of the three eligibility criteria (https://www.gov.uk/guidance/innovative-licensing-and-access-pathway).

3.Please provide copies of any documents including MHRA’s assessments of the eligibility of Aumolertinib and Sugemalimab for the ILAP, including the assessment of “Innovation” provided by these medicines as well as the other criteria listed in the ILAP Guidance.  For the avoidance of doubt, I do not seek access to commercially confidential information which is exempt from disclosure under Section 43 FOIA and, to the extent that the documents include such material, I am content for it to be redacted.

MHRA refuses to confirm or deny that it holds any assessments on the eligibility of aumolertinib and sugemalimab for ILAP. The duty in Section 1(1)(a) of the Freedom of Information (FOI) Act 2000 does not apply, by virtue of Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of that Act. This should not be taken as an indication that the information you requested is or is not held by the department.

4.Please provide copies of any working papers, assessments, final or draft guidance or policies that have been prepared and/or used by MHRA for the purposes of determining or informing situations where MHRA will authorise medicines or indications on the basis of clinical data solely generated in countries where the population is different from that in the UK, including where all clinical data have been obtained in the People’s Republic of China (“China”).

MHRA holds no working papers, guidance or policies on the authorisation of medicines/indications on the basis of clinical data solely generated in countries where the population is different from that in the UK. Concerning any assessments that would have been done for the authorisation of medicinal products based on clinical data solely generated in countries where the population is different to the UK, please could you provide a specific product name and product licence number for an authorised product where you would like to see the MHRA assessment? Please note that all assessments for medicinal products authorised after 31 October 2005 are published in Public Assessment Reports (PARs) by MHRA and the European Medicines Agency. A link to these are provided below:

https://www.ema.europa.eu/en/medicines

https://products.mhra.gov.uk/

If you have a query about this email, please do not hesitate to contact us at info@mhra.gov.uk

If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please email: info@mhra.gov.uk

After that, if you remain dissatisfied, you may write to the Information Commissioner at;

The Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

They will make a decision on whether or not we have interpreted the FOIA correctly in handling your request.

Yours sincerely

MHRA Customer Experience Centre