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“Protracted delays” in ruling whether pharmaceutical companies have broken the industry code of conduct on marketing their products are untenable for public and patient health, researchers have warned.
In a study, published in Regulation and Governance on 20 June 2024, researchers examined drug company misconduct and the resolution of complaints under the UK’s self-regulation system between 2004 and 2021, finding that the average time taken to reach a decision has significantly increased since 2015.
The Association of the British Pharmaceutical Industry’s (ABPI’s) code of practice regulates the marketing of prescription medicines in the UK and is administered by the Prescription Medicines Code of Practice Authority (PMCPA), meaning the industry is self-regulated as there is no government involvement.
Over the 18-year period studied, the PCPMA ruled on 1,797 individual cases, identifying code of practice breaches in 1,139 cases, involving 159 companies.
The researchers found that the PMCPA took an average of 38.4 weeks to conclude a case in 2021, compared with an average of 11.8 weeks in 2004 — an increase that the researchers described as “alarming”.
“Such protracted delays are untenable from a public and patient health perspective, as they allow companies to take advantage of inappropriate promotion for extended durations,” they warned.
The study also revealed evidence of “persistent and often severe misconduct committed by pharmaceutical companies operating within the UK”.
While 63 of the 159 companies (39.6%) faced sanctions in one year, the majority were repeat offenders, with 20 companies sanctioned in at least half of the 18 years studied, and 10 sanctioned in 14 or more of the years studied.
Novo Nordisk was suspended from the ABPI for two years in 2023, after the company sponsored a weight management course linked to promoting its weight-loss drug Saxenda (liraglutide).
Overall, between 2019 and 2023, the PMCPA adjudicated against Novo Nordisk ten times for inappropriate marketing of Saxenda.
Alex Fell, director of the PMCPA, said that there had been an increase in both the number and complexity of complaints in recent years, “which has unfortunately caused some cases to take longer to resolve than we want; addressing this is our highest priority”.
“The code of practice panel has a public duty to ensure that each case is considered carefully and with due diligence and rigour. Each allegation must be considered appropriately and many recent complaints include multiple allegations,” he said.
He added that the ABPI and PMCPA conducted a public consultation earlier this year on changes to the ABPI code and the Constitution and Procedure.
Study leader Shai Mulinari, associate professor in sociology at Lund University in Sweden, told The Pharmaceutical Journal that the study pointed to many problems with self-regulation.
“This includes the many breaches annually, and the severity of some of the breaches, for example, as seen recently with Novo Nordisk. There are also serious problems with protracted delays in completing cases and the arguably non-significant sanctions imposed on breaching companies even for serious offences.”
He added that the increasing complexity of cases likely related to more complex marketing approaches taken by companies, but this should not lead to delays in rulings being made.
“We believe the severity of sanctions need to increase significantly. In fact, currently, there are no true financial penalties for breaching companies,” he explained.
Amit Aggarwal, executive director of medical affairs at the ABPI, said: “The ABPI continues to support the work of the independent PMCPA and the principle of self-regulation as a proportionate, transparent, and effective framework to uphold high standards and hold pharmaceutical companies to account.”
“The ABPI board fully supports giving the PMCPA the resources they need to address any backlog, as well as looking at proposals for how the ABPI code of practice can be reformed to ensure simple cases are quickly resolved and more serious cases prioritised.”
