Moderna’s missteps spotlight PMCPA’s role in upholding pharma ethics

The pharmaceutical industry operates under a complex regulatory landscape, balancing government oversight with self-imposed standards. Ben Hargreaves finds that the ABPI recently updated its code of practice and its self-regulatory division took action against Moderna.

Across industries, complaints about regulation are widespread, often highlighting concerns that regulatory frameworks limit business opportunities, introduce complexities, and slow down innovation. However, in the pharmaceutical sector, where the stakes involve public health and safety, regulatory oversight is particularly stringent. Governments and regulatory bodies impose rigorous requirements to ensure the safety, efficacy, and ethical management of medicines, making this sector one of the most highly regulated industries globally.

Yet, the pharmaceutical industry also exercises a significant level of self-regulation, aiming to uphold high ethical and operational standards. Industry bodies establish and enforce guidelines on issues such as clinical trials, marketing practices, and pricing transparency. The primary motivation behind this self-regulation is to maintain public trust and preempt further, potentially more restrictive, government-imposed regulations. By actively managing their practices, pharmaceutical companies aim to demonstrate responsibility, meet public and governmental expectations, and avoid interventions that could impose additional burdens on business operations. This dual system of regulation—both governmental and self-imposed—reflects the complex balance the pharmaceutical industry seeks to maintain between advancing healthcare and navigating operational constraints.

ABPI’s self-regulatory approach

In the UK, the Association of the British Pharmaceutical Industry (ABPI) created the Prescription Medicines Code of Practice Authority (PMCPA), which is the self-regulatory body that administers the former’s code of practice for the UK industry. The organisation was established in 1993 and exists as a division of the ABPI, though it is stated that the PMCPA operates independently. Its role encompasses operating the complaints procedure against member companies, providing advice, training, and guidance on the code of practice, arranging conciliation between pharma companies when requested, and examining samples of advertising and meetings.

The PMCPA is guided by a code of practice, established by the ABPI in consultation with its stakeholders. This sets standards for the promotion of medicines for prescribing to health professionals and other relevant decision-makers in the UK. It also includes requirements for the provision of information to patients and the public, as well as guiding relationships with patient groups.

In September, the ABPI updated its code of practice with three key sets of changes:

• An update to how prescribing information can be provided
• A new ‘Constitution and Procedure’ for the PMCPA
• Elements of the ABPI Code moving from guidance to mandatory requirement

The first change simply relates to the ability to provide prescription information for printed and certain digital promotional material through QR codes. The second change allows for a new abridged complaint procedure to deal with less serious complaints in a “proportionate and resource-efficient manner.”

The last update shifts two elements of disclosure from being recommended to being mandatory. With the first relating to Disclosure UK, which highlights the relationship between healthcare professionals (HCPs) and healthcare organisations, and sees companies being required to submit links to disclosure information published on individual company websites. The second change sees companies being required to have a written agreement in place setting out what support will be provided for HCPs and relevant decision-makers to attend events and meetings. These new rules will come into force at the beginning of 2025.

PMCPA takes action

The objective of these changes is to reassure the UK government and the public that the industry is operating openly, whilst encouraging a more collaborative, rather than incentivised, relationship with HCPs. This is important for the industry as there have been notable cases where it has been accused of encouraging HCPs to prescribe certain medications.

One example of a company that was recently taken to task by the PMCPA is Moderna. In October, the company was reprimanded twice by the body over breaches of the ABPI code. One instance saw the company promoting its COVID-19 vaccine, Spikevax, in a manner “that was inconsistent with a summary of the product characteristics.” The additional case related to a failure by Moderna to ensure that only approved clinical trial recruitment materials were used.

The former case stems from a Moderna presentation at the European Congress of Clinical Microbiology and Infectious Disease in April 2022. A complaint was filed against the company based on the presentation and how it was “promoting Spikevax, rather than being a scientifically accurate and balanced presentation.” Moderna defended itself by outlining that it had not been a member of the ABPI at the time of the presentation, which the PMCPA countered by stating that it accepts complaints under its code prior to a company agreeing to them.

The latter case involved an unapproved WhatsApp message that was used to promote the recruitment of children into a clinical trial with financial compensation that was alleged to be “inappropriate.” The complaint was delivered to the PMCPA by the Children’s COVID Vaccine Advisory Council, which noted that a paediatrician at one of the trial centres posted an unapproved offer in a WhatsApp group. Within the message, there was a proposed payment of £1,500 on completion of the study, with the complainant noting that this could place children at the risk of coercion to participate in the trial.

Public trust in question

The PMCPA concluded that in breaching the ABPI Code, the company had “brought discredit upon, and reduced confidence in, the pharmaceutical industry.” Having been found to be in breach in both cases, Moderna will be required to pay administrative charges, provide a written undertaking, and may be subject to additional sanctions, as per the PMCPA’s complaints procedure.

There are two levels of administrative charges, as Moderna did not appeal against the findings then it will pay £5,000. As in both cases, Moderna breached clause 2 of the code, the company will have to pay an additional £4,000 towards the cost of advertising its wrongdoing in the medical, pharmaceutical and nursing press. For a company that earns billions in revenue from its respiratory products, notably Spikevax, this sum will hardly make a dent in its coffers. However, from a public relations perspective, being found to have acted in a fashion that was found to discredit the industry from the ABPI is a significant blemish on the company’s reputation.