Repurposing Medicines Toolkit - Guidance for navigating the process

The British Generic Manufacturers Association (BGMA) represents the interests of UK based manufacturers and suppliers of generic medicines and promotes the development of the generic medicines industry in the United Kingdom.

The BGMA currently has 33 member companies. BGMA are willing to be very involved at the earlier stages of development and part of their remit is to ensure that there is a neutral voice in discussions such as those around pricing. BGMA have a wealth of experience in the repurposing field and are very happy to engage. They can broker relationships with their member companies as appropriate.

BGMA can be contacted via email at info@britishgenerics.co.uk

Creation of novel IP
It is important to make clear that creation of novel IP as a means to commercial gain is not always a requirement for progression of a repurposed therapy. It is sometimes assumed that funders will require this in order to consider an application for funding, but this is most often not the case. Charity and public funders, MHRA and BGMA are keen to see repurposed medicines take the most efficient path to patient treatment. Novel IP may sometimes be generated along the way, for example if a new formulation is developed, but this is by no means always the case.

Freedom to operate
IP does still need to be considered, in that researchers will need to be clear that there are no potential blocks, from an IP perspective, that may prevent the treatment reaching patients. To ensure that the programme can progress smoothly you should arrange for someone to check any freedom to operate issues. If you are in a university your technology transfer office (TTO) should do the required diligence around this and clarify the IP position. If there is an issue you may need to speak with patent owners in order to be able to proceed freely.  Most funders require sign off on applications by the host institution's TTO.

Patents
The key intellectual property in this area is patents, which are awarded by national or regional patent offices and give the owner the right to prevent others from practicing their invention, and can be very valuable. One of the key criteria to obtain a patent is that the subject matter must not have been made public prior to the application for the patent. It is, therefore, very important not to publish, whether in a written article or orally, the subject matter of the invention before a patent application has been made

Medicines and Healthcare products Regulatory Agency

The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.

MHRA offer scientific advice at various stages in the development pathway. There is sometimes a fee for this advice (never for paediatric rare diseases) and further information can be found on their website.

The agency can be contacted for scientific and/ or regulatory advice via their MHRA Innovation Office and/or the Innovative Licensing and Access Pathway

The MRC Regulatory Support Centre (RSC) provides support and guidance on the legal and ethical requirements for research involving human participants, their tissues, or data. We work with the academic research community to support high quality research and ensure policy makers hear the voice of the researcher.

Their website has guidance for different areas of health research. If you are quite new to healthcare research their Understanding health research page gives a good introduction to help you navigating the regulations governing this field. More detailed guidance can be found in the following:

• Using human samples in research
• Using data about people in research
• Guidance for developing healthcare products (including medicines)

The RSC e-learning website has modules on using data about people, and human tissue in research.
For specific questions relating to your project, the RSC can be contacted on rsc@mrc.ukri.org

NICE's role is to improve outcomes for people using the NHS and other public health and social care services, by:

• Producing evidence-based guidance and advice for health, public health and social care practitioners.
• Developing quality standards and performance metrics for those providing and commissioning health, public health and social care services.
• Providing a range of information services for commissioners, practitioners and managers across health and social care.

More detail can be found on the NICE website.

The NHS Innovation Service has been developed to accelerate the spread of promising and impactful innovations into the NHS. Much of the information available in the Innovation guides is relevant for drug repurposing projects.

The service aims to provide an online service for health innovators, to support them to get their innovations, at any stage, adopted in the NHS. This includes helping innovators understand the regulations and standards they will need to meet; the real-world evidence they should demonstrate; and the NHS procurement and reimbursement processes.

Innovators using the service can receive coordinated support from organisations who have experience, knowledge and expertise in developing and adopting healthcare innovations.