In order to consider the impact of Brexit on the ABPI Code of Practice for the Pharmaceutical Industry (a popular question) it is worth looking briefly at some of the history of the ABPI Code and its operation.
There have been so many changes since I first started working on the ABPI Code in 1989. At that time the ABPI had just celebrated 30 years of its Code (established in 1958) and the International Federation of Pharmaceutical Manufacturers and Associations’ (IFPMA) code was a few years old. The Prescription Medicines Code of Practice Authority (PMCPA) had not been established and the European Federation of Pharmaceutical Industries and Associations (EFPIA) did not have a code. At that time IFPMA and EFPIA only had associations as members. Discussions were just starting about the content of an EU Directive on pharmaceutical advertising. The internet had only just been invented.
The ABPI established the PMCPA in 1993 to operate the Code at arm’s length from the ABPI itself. The independent operation of the PMCPA remains critical to maintaining the confidence of the public and other stakeholders such as the Medicines and Healthcare products Regulatory Agency (MHRA) as well as its role in carrying out a public function.
UK advertising law is administered by the MHRA on behalf of the health ministers. The Code reflects and extends beyond UK law. The controls in the UK are thus based on the long-established system of self-regulation supported by the statutory role of the MHRA. Self-regulation is a privilege not a right.
The pharmaceutical industry’s commitment to self-regulation in the UK is illustrated by the regular changes to the ABPI Code and how it is operated to continue to improve standards in the industry. The aim of every review is to ensure that confidence in self-regulation continues, with support from the MHRA, the public and other stakeholders being key.
The ABPI Code continues to set out high standards to help the pharmaceutical industry meet its commitment to benefitting patients by operating in a professional, ethical and transparent manner to ensure the appropriate use of medicines and support the provision of high quality patient care. The ABPI Code applies to members of the ABPI and to a number of companies which, although are not members of the ABPI, agree to comply with the ABPI Code and accept the jurisdiction of the PMCPA.
The inclusion of principles in the introduction to the ABPI Code provide a helpful overview of self-regulation. The industry’s decision to provide more detailed information about its work with patient organisations, the publication of information about transfers of value and the establishment of Disclosure UK by the ABPI, as well as the decision in 2011 to stop giving brand reminders in the form of mugs, calendars, calculators etc are all examples that show that the industry is committed to responding to criticisms. Companies have their own codes, handbooks etc, to ensure that employees understand and follow the company approach. Many of these company documents are publicly available and some have requirements that go even further than the applicable codes.
The PMCPA and ABPI have contributed both to the development of EU pharmaceutical advertising law and EFPIA codes (and the IFPMA code). Many of the existing requirements and experiences in the UK were pivotal in discussions. The development of an EU Directive on pharmaceutical advertising led to the establishment of the first EFPIA Code in 1992 which covered the promotion of prescription only medicines to health professionals. This was followed by EFPIA codes covering relationships with patient organisations (2008) and disclosure of certain transfers of value to health professionals and healthcare organisations (2014).
It is interesting to consider how these relationships and shared experiences might change as a result of the UK’s decision to leave the EU. The most important thing to remember is that the ABPI is not leaving EFPIA. The PMCPA and ABPI will continue as members of the groups at EFPIA that are concerned with improving standards and sharing experiences in relation to ethical behaviour as well as matters covered by the EFPIA codes. There is always much to learn from other approaches. As a member of EFPIA, the ABPI must ensure that the ABPI Code continues to adopt provisions no less rigorous than those in the EFPIA Code except where these are in conflict with applicable national laws or regulations. Under the EU legislation advertising has always been a national responsibility. The industry in the UK would like to see some changes to UK law, for example the PMCPA and ABPI have started discussions about possible changes to the provision of prescribing information with the MHRA.
Communication channels are always evolving, with digital channels being a challenge, particularly in relation to the prohibition in UK and European law on advertising prescription only medicines to the public which is reflected in the ABPI Code. The public and patients increasingly want more information about medicines and treatments. Regulators in some EFPIA countries consider that everything issued by a pharmaceutical company is advertising and thus all communication to the public about prescription only medicines is prohibited. Other regulators take a different view and support the industry’s role in providing information which meets certain quality standards, about medicines to the public and patients. This is where self-regulation, supported by statutory regulation, as in the UK, can work well in providing more detail to help understanding of the challenges.
The ABPI Code is sometimes seen as being stricter than other codes in Europe. This is not always so. There are examples where the UK is less restrictive, such as in allowing the use of data on file and supporting health professionals to attend meetings outside their home country. The majority of the requirements are similar which is not surprising given the role of the EFPIA codes. There are some specific UK provisions. The publication of detailed case reports acts as a sanction as well as supporting companies’ understanding. The case reports published in the UK (pmcpa.org.uk) are widely read and the learnings are regularly communicated to relevant individuals. The transparency of information in the UK including the publication of detailed case reports is another demonstration of industry’s commitment to self-regulation.
The PMCPA (and EFPIA) have had to consider the impact of digital communication such as websites, email, Twitter, Facebook, Instagram, etc and ensure that quality standards apply irrespective of the channel of communication. Changes in the ways material is provided should not detract from the importance of ensuring that what is communicated is appropriate for the audience and that it complies with relevant codes and legislation.
At the moment the ABPI and PMCPA are working on changes to the ABPI Code to include implementation of the latest EFPIA Code of Practice (which primarily incorporates the current three EFPIA codes into one) as well as ensuring the ABPI Code remains current and updating areas that might benefit from more explanation as a result of cases considered under the ABPI Code. A new layout is proposed, similar to that used in the EFPIA Code. The review has looked at the whole area of advertising, communication and interaction including the content of the supplementary information. A consultation will be issued in 2020 and details will be made available on the PMCPA website. The PMCPA is always keen to receive comments on the Code and its operation and always considers responses to consultations very carefully. It will be particularly important that companies share their views with the PMCPA.
One thing which will not change is our commitment to working with EFPIA, IFPMA and others to provide support to those who use the codes. The PMCPA will continue to provide training, informal advice and guidance and part of this work includes our recently redesigned website (sign up for e-alerts if you have not already done so).
The short answer to how the ABPI Code will operate post Brexit is, for now, that there will not be many resulting changes, (given the impact of COVID 19 it seems inappropriate to use the phrase ‘business as usual’). Longer term, as ever, the ABPI Code will have to balance the needs of all, including patients, health professionals etc and the public, as well as UK law and the obligations for companies and the ABPI resulting from membership of EFPIA and IFPMA taking into account our ever-changing world.