ABPI Code “Tidy Up” Reflects Digital Developments
Executive Summary
The Association of the British Pharmaceutical Industry’s revised code of practice reflects digital developments and replaces the 2016 version.
The updated Association of the British Pharmaceutical Industry code of practice that came into effect at the start of the year reflects digital developments and highlights the ethical expectations and responsibilities of industry.
Changes Incorporated into the 2019 version of the code largely mark part of an “incremental tidying up” of the code, Jill Pearcy, director of ABPI code engagement, told the Pink Sheet.
ABPI members agreed changes to the association’s 2016 code of practice on Dec. 4, 2018. The new code came into operation on Jan 1, 2019, though a transition period means that companies have until April 30 to adapt their procedures and get ready for any new requirements.
Earlier this year the ABPI consulted on proposals for changes to its code of conduct, which it hoped would better reflect digital developments and regulatory changes, such as conditional licensing. (Also see "UK Industry Association Consults On Changing Code Of Practice" - Pink Sheet, 30 Aug, 2018.) There were responses from 40 ABPI members as well as from other stakeholders, including the Medicines and Healthcare products Regulatory Agency, royal colleges, patient organizations and healthcare professionals.
The code has existed for 60 years and inevitably requires “an incremental tidying up,” Pearcy said. One important area of change that the new code aims to reflect developments in the digital space. For example, the code now refers to “digital ways of delivering information as well, such as whether you have links and whether you expect to be online or off line,” she said. “It’s future proofing in a sense, and making sure it reflects current business practice.”
Also, for the first time the principles of the code are set out at the beginning of the document. Previously, the principles were “a little bit more buried” within the code, Pearcy said. The aim of giving the principles headline status is to emphasize the reasons behind the code. According to Pearcy, these are “to set out industry’s commitment to patient safety and ethical behaviour and to make absolutely clear what companies are responsible for and that we take it very seriously. It is to really crystallize this commitment from the industry to operate within a professional and ethical manner”.
More Change Ahead
Updating the code is an ongoing process and the ABPI, which represents the UK R&D-based pharmaceutical industry, expects to publish more changes in 2020. The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), organisations of which the ABPI is a member, are set to publish updates to their own codes this year. “We will take a good look at what is in their code and make sure we are bringing those in and reflecting them in our code as well,” said Pearcy.
Brexit could also lead to further changes if it results in relevant legislation changes in the UK.
From the editors of Scrip Regulatory Affairs