The UK’s Association of the British Pharmaceutical Industry (ABPI) has, together with the Prescription Medicines Code of Practice Authority (PMCPA), published the new Code of Practice for the Pharmaceutical Industry (the 2021 Code).  Publication of the 2021 Code follows a consultation conducted in 2020, with subsequent revisions prior to approval on 12 January 2021.

The 2021 Code will be implemented from 1 July 2021  and represents a significant structural revision of the current 2019 Code. It is described as the most extensive revision to the Code in over 30 years. There is no transition period for the new arrangements after 1 July 2021, other than for medical and educational goods and services (MEGS). The supplementary information to Clauses 20 and 23 sets out a 6 month period (until 31 December 2021) during which ongoing MEGS, provided under Clause 19 of the 2019 Code, may continue without the need to be reclassified as either a donation or collaborative working and comply with any new requirements as a result of this change.

Some of the key changes introduced through the  2021 Code are summarised below.
Continue Reading New 2021 Code of Practice for the British Pharmaceutical Industry

Publication of clinical trial data and results continues to be a hot topic in the EU. A recent BMJ article investigated the level of compliance with the European Commission’s requirement that the results of all trials are published within 12 months of completion. The Commission guidance expands on the obligations in the Clinical Trials Directive, and states that for all trials (paediatric and non-paediatric), result-related information should be supplied and made public within 12 months of the completion of the trial (not after grant of the marketing authorisation), including a summary of the results and conclusions.

The retrospective cohort study found that despite the Commission guidance, of the 7,274 trials where results were due, only 49.5% reported results, although trials with a commercial sponsor were substantially more likely to post results than those with a non-commercial sponsor (68.1% compared to 11.0%).


Continue Reading Update on Clinical Trials Transparency in the EU

The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) has recently published a new version of its Code of Practice that will come into force on January 1, 2019, updating the current Code of 2012. IFPMA members, including the EFPIA and PhRMA, must incorporate the new provisions into their own codes by this date, to the extent necessary.

In addition to the text of the Code, the IFPMA has provided detailed guidance on the key amendments made. First, the Code is now underpinned by a guiding Ethos that replaces the previous iteration’s ‘Guiding Principles’. Secondly, several provisions have been updated, notably the section on gifts. We highlight the key changes below.


Continue Reading The new IFPMA Code of Practice