In June 2019 the Association of the British Pharmaceutical Industry (ABPI) released new guidance on working with patients.

Why is this necessary? In 2014, the NHS launched its Five-Year Forward View making a collaborative relationship with patients, carers, third sector and communities central to the future NHS because patients are why the NHS exists.

Patient and Public Involvement (PPI) is key to giving a voice to patients to develop the treatment pathways and to underserved communities. PPI is key to improving patient safety and driving up standards of care by delivering the care that people want rather than the care it has been considered that they need. The Kingsfund, an independent charity working to improve health and care in England, is a good resource to understand more about PPI and the NHS.

Kingsfund

Why is PPI important to Regulatory Affairs?

A recent publication by the European Medicines Agency (EMA) on the patient journey from laboratory to centrally authorised medicines, contains within it a section on Patient involvement in scientific advice:

“Patients are often involved in scientific advice. They are invited to share their real-life perspective and experience in relation to a medicine in their disease area. This can help medicine developers and regulators understand better what will work for that patient group and what they consider important.

In 2017, one in five scientific advice procedures involved patients and the SAWP members considered that in almost every case (93%) patients provided added value to the scientific advice. In more than one in four cases, the scientific advice recommended that the development plan be modified to reflect patient advice.”

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Therefore, the ABPI guidance ‘working with patients’ not only reflects the sea change in how development is becoming more patient centric, but how we as regulators should consider the patient voice when initiating scientific advice. A summary of the six topics covered in the ABPI sourcebook is presented below.

ABPI guidance ‘working with patients’

A summary of the six topics covered in the ABPI sourcebook
  • Principles and agreements: companies must have written agreements when working with patient organisations, and principles of clarity, integrity, independence and transparency should underpin all collaborations.
  • Defining what is a patient organisation, patient or patient advocate: this has an impact on what information can be provided, for example, prescription medicines cannot be advertised to the public.
  • Events and meetings; the code has strict guidance on the purpose of the meetings and what can and can’t be included, for example, meetings must have a clear educational purpose.
  • Research and development; Patient organisations or charities can play a key role in representing the patient voice due to their unique position of having direct contact with patients while at the same time funding medical research, however, however agreements must be in place and companies must disclose details of the patient organisations that they provide financial support to, in line with the Code.
  • Product launches: Many companies work with patients to shape input to new product launches. In terms of compliance a new product launch is no different to any other activity and the ABPI code applies in the same way, with rules on promotion, information, agreements and events.
  • Payments; The ABPI supports collaboration between industry and patients in the interests of enhancing public health, however, companies must make publicly available each year a list of the patient organisations to which they provide support, both financial and non-financial with a description of what the support is for and the monetary value.

You can read more about the ABPI new guidance on working with patients through these two links.

New Guidance for working with Patients
Working with Patients Brochure

JensonR+ Limited can support you for both National (UK and other agencies) and European scientific advice. We have a team of experienced regulatory professionals to help advise and support you through these processes.

Contact us at consultancy@jensongroup.com.

Janet Worrell