National patent group— Memorandum of understanding

Vanessa Chapman, Associate Professional Lead for Medicines Information, Midlands & East, Midlands and East Medicines Advice Service (Midlands site) & UK Drugs in Lactation Advisory ServicePublished

Memorandum of understanding between the NHS and pharmaceutical companies relating to patent information and availability of generic medicines

The NHS National Patent Group (NPG) was established to monitor patent expiries, gather intelligence on potential generic/ biosimilar launches and plan for their introduction into the NHS in a timely and safe manner.  The group is comprised of senior members of the Specialist Pharmacy Service (Medicines Information and Procurement) and NHS England Commercial Medicines Unit and Specialised Commissioning.

During our discussions around patents and/ or generic launches with the pharmaceutical industry we may record some information provided to us in a database.

This Memorandum of understanding describes what we will do with the information and how we will use it.

 

Documentation of data

The NPG collects information on the following:

  • patent expiries
  • legal challenges to patents
  • commissioning information and plans
  • proposed or potential generic/ biosimilar availability

The NPG recognises that certain information is confidential and/or commerciality sensitive and is provided on the understanding that it is not made public or shared with competitor organisations.  Such data will be annotated within the database as ‘CIC’ (commercial in confidence).

By providing members of the NPG with relevant information there is no promised or dependent future commercial relationship made between any part of the NHS and any company regarding purchase of potential products.

Access to the database

The database will be hosted on a secure password protected website.  Only members of the NPG have access to the database.

A member of the NPG will only be granted access to the Patents Database as an administrator if they:

  1. have a legitimate and clearly stated purpose for access to the information
  2. are responsible for providing the NHS (or parts of the NHS) with information on new medicines
  3. have signed a confidentiality agreement

All administrators must maintain their own declaration of interest for their employing organisation and/ or accountable body.

Use of data

Data can be extracted from the database in the format of reports downloaded from the website which will not be used or distributed to anyone else outside NPG in this format for any purpose outside that set out in this agreement.

All administrators shall use their best endeavours to ensure that all data drawn down from the database is used only for providing advice to the NHS regarding planning and providing support for the introduction into the NHS of new medicines and indications and for such other purposes as may be set out in this agreement. The administrators shall use the same level of care to generally keep confidential and prevent any unauthorised use or disclosure of the confidential information.

The NPG will only distribute advice documents for use by the NHS in a format which either:

  • presents only non-confidential information, or
  • presents the data in a format such that such confidential information is not able to be discovered from reading the document, or
  • clearly identifies any confidential information as such and places restrictions on readers as to the further non-disclosure of confidential information by the reader.

The NPG shall ensure that appropriate and effective administrative procedures are in place to limit damage by managing any breaches of security or breaches of confidential information however they should occur.

Attachments