The relationship between the pharmaceutical industry, healthcare professionals and healthcare organisations plays a vital role in the development of medicines. However, there is also increased industry as well as general public demand for clearer and objective reporting on the research, clinical trial/testing, distribution and advertising practices involved in bringing pharmaceutical products to the market and administering treatments.
Two recent developments reflecting this shift towards increased openness around industry practices are the publication of:
- a new code of practice by the Association of the British Pharmaceutical Industry (ABPI), about which we provided a general overview in a recent article; and
- an annual report by the Medicines and Healthcare products Regulatory Agency (MHRA) on the regulation of medicines advertising to promote transparency.
ABPI code 2021
The new ABPI code, which will take effect on 1 July 2021, enshrines transparency as a core fundamental principle applicable to all industry stakeholders. The Prescription Medicines Code of Practice Authority (PMCPA) is the self-regulatory body established by the ABPI to administer the code, and will be tasked with enforcing these transparency obligations and investigating any related complaints made against pharmaceutical companies. The PMCPA may conduct compliance audits on pharmaceutical companies, publish public reprimands or advertisements in the medical, nursing and pharmaceutical press, and report to the ABPI Board requesting a company’s suspension or expulsion from ABPI membership.
One example of the APBI’s increased focus on promoting industry transparency is the "Disclosure UK" database, which is part of a Europe-wide initiative to increase transparency between pharmaceutical companies and health professionals as well as organisations it works with. Disclosure UK is also the means by which UK pharmaceutical companies are meeting their obligations under the European Federation of Pharmaceutical Industries and Associations (EFPIA) Disclosure Code and provides the public with a searchable database recording any remuneration and benefits in kind made by pharmaceutical companies to healthcare professionals and healthcare organisations. Disclosing the terms of these relationships openly and transparently seeks to instil greater confidence in patients regarding the supply and administration of their treatments, and emphasise that sharing knowledge to improve patient outcomes is the industry’s key priority.
The MHRA’s annual report highlights its focus going forward on ensuring that companies comply with industry guidelines on advertising medicines, as well providing tailored regulatory advice to self-regulatory bodies and individual advertisers.
In addition to its Blue Guide, the MHRA publishes substantial public and industry-tailored guidance to promote greater transparency across different areas within the pharmaceutical sector, including:
- Reporting and registration requirements in connection with clinical trials
- Conformity and registration requirements governing the supply of medical devices
- Import/export obligations on pharmaceutical companies and healthcare product providers
- The wider legislative requirements that apply to medical and pharmaceutical products
Similarly to the PMCPA, the MHRA enforcement group also investigates complaints made against companies relating to medical products and devices, seeking to facilitate dialogue between members of the public and industry actors and act as a central registration and reporting facility.
It will remain to be seen how effective the new ABPI Code and MHRA guidance will be in promoting increased openness and public awareness regarding pharmaceutical industry practices. Businesses and individuals engaging with this sector should familiarise themselves with the guidance and resources available to stay informed and benefit from the drive towards greater transparency.