The Holiday season of 2023 proved to be a busy one for innovative pharmaceutical companies in the UK and their legal and regulatory teams.

UK pharmaceutical companies are already number-crunching through two new price control systems for 2024 (please see our blog and audiocast).  In addition to the UK pricing regime changing, there are proposals to update advertising rules and the procedure for adjudicating upon advertising complaints.   

On 13 December 2023, the Association of the British Pharmaceutical Industry (“ABPI”) published proposals to update the 2021 ABPI Code of Practice for the Pharmaceutical Industry (“ABPI Code”) and the Prescription Medicines Code of Practice Authority (“PMCPA”) Constitution and Procedure (which sets out the procedure for adjudicating upon advertising complaints).  Companies have until 29 February 2024 to contribute to the consultation.

Many of the proposed changes to the ABPI Code are clarificatory in nature, but the planned changes to the complaints process may be of particular interest to in-house legal teams.  These changes are designed to make the PMCPA complaints process less formulaic and more flexible.  This could help manage relatively straightforward cases with greater efficiency, whilst also accommodating for cases which involve serious allegations and/or complex facts.  If implemented as proposed, the changes are likely to give PMCPA cases a more judicial or legalistic feel, particularly when it comes to case management.

Proposed Changes to Complaints Process

A.                Case Management

Under the proposals, the Director of the PMPCA has the power to issue “case management directions.”  This essentially aligns with the English Court rules, by which judges issue directions to set the terms and processes for a particular case.  Examples of case management directions envisaged under the proposals include determination as to what material may be put before the adjudicating panel and whether a hearing is to be conducted remotely or in-person.

In the case of an appeal against a PMCPA Panel ruling, the PMCPA Director may issue a direction setting aside the decision of the Panel where there has been a procedural error (i.e., an error in complying with the process set out in the PMCPA Constitution and Procedure).

The proposals also introduce an “overriding objective” for the PMCPA to deal with cases “fairly and justly while protecting patient safety.”  This also borrows from English legal concepts.

In practice, the overriding objective requires the PMCPA to, among other things, (i) take a proportionate approach to case management based on the importance and complexity of the issues at stake; and (ii) ensure that parties fully participate in the proceedings.  The latter principle seeks to encourage complainants to resolve complaints using the relevant company’s internal or external whistleblowing and/or dispute resolution procedures, and stay contactable if the matter ultimately results in a PMCPA investigation.  This measure appears to respond to the growing trend of anonymous, non-contactable complainants who may be current or former company employees.  However, anonymous complaints will continue to be accepted.   

B.                Abridged Complaints Procedure

The proposals envisage the introduction of an abridged complaints procedure.  This would apply where it is likely, in the view of the Case Preparation Manager (a member of the PMCPA assigned to the case by the Director), that there has been a breach of the ABPI Code for all matters alleged.  The allegations must only relate to certain clauses specified in an approved list. 

The intention behind the abridged process seems to be to avoid a lengthy and burdensome investigation for “open and shut” cases.

Under the abridged complaints procedure, respondent companies will present their findings to the PMCPA.  If (i) the respondent company accepts the alleged breach(es) of the ABPI Code and has provided a written undertaking to cease relevant activity and to take steps to avoid a similar breach in the future; and (ii) the PMCPA confirms there are no systemic compliance issues at issue, the case would close without further PMCPA investigation.  If these criteria are not satisfied, then the case will proceed following the full complaints procedure. 

There is no right of appeal under the abridged procedure and administrative charges equal to 50% of the cost of a case going through the full complaints procedure will be payable by the respondent company.

The abridged process could allow less serious infringements to be dealt with in a resource-efficient manner.  However, this may also depend on how expansively the PMCPA construes allegations following a complaint (historically, the PMCPA has tended towards over-expansiveness, asking companies to respond to several allegations in relatively simple cases).

C.                 Additional Procedural Changes

The proposals also contain several additional proposed changes to the PMCPA’s Constitution and Procedure, including:

  • An extension in the time permitted for companies to respond to a complaint from 10 working days to 15 working days.  This recognizes the increased complexity of complaints in recent years and accordingly aims to allow companies adequate time to submit a thorough response.
  • An extension of the timeframe for the payment of administrative charges from 20 working days to 30 working days.  

Proposed Changes to ABPI Code

The proposals encompass various – mostly clarifying ― changes to the 2021 ABPI Code. 

  • However, one proposal relates to a new Clause 10.3, which would require companies to complete an “educational needs assessment” where they are providing support for individuals (such as clinicians) to attend conferences/meetings.  This assessment should provide the rationale for the decision to support the attendance of the individual in question.  There is little further detail about what the assessment should include, but the proposed change would clearly increase the compliance burden when providing support to attend conferences.
  • There is also a requirement for member companies to develop and maintain policies and standard operating procedures to communicate corporate standards, expectations and behaviour in line with Clause 5.1 of the Code (which requires companies to maintain high standards). 
  • The proposals would also introduce a new Clause 5.2 that requires company personnel to maintain a high standard of ethical conduct and comply with relevant Code provisions.  The supplementary information to this new clause provides that companies are responsible for the actions of their personnel (including those retained by way of contract and third parties), even if they are acting contrary to instructions. 

Other notable changes include:

  • Clause 8.1 (Supplementary Information) – Representative Briefing Material.  The proposals amend this clause to clarify that “representative briefing material” is not in itself considered promotional material.  However, companies should still certify such material in a similar manner to promotional material.
  • Clause 12 – QR Codes to Access Prescribing Information.  The proposals introduce the use of quick response (“QR”) codes to access prescribing information from printed promotional material.  Companies would have the option to provide prescribing information either as text or through a QR code, provided they ensure clear instructions to scan for prescribing information are displayed.  The ABPI makes clear that the changes envisaged here were developed in full consultation with the Medicines and Healthcare products Regulatory Agency (“MHRA”) and therefore align with the MHRA’s guidance in respect of QR codes.   

Clauses from the 2021 Code that have now expired would also be removed under the proposals.

Next Steps

Organizations wishing to respond to the proposals should do so before 29 February 2024 using the MS Forms Survey found here.

Covington will continue to follow developments and provide further updates.

If you would like to discuss the latest developments and what they may mean for your company’s operations, please contact: Grant Castle, Robin Blaney, Brian Kelly, Raj Gathani or Dan Spivey.

Photo of Grant Castle Grant Castle

Grant Castle is a partner in London and Dublin practicing in the areas of EU, UK and Irish life sciences regulatory law. He supports innovative pharmaceutical, biotech, medical device and diagnostics manufacturers on regulatory, compliance, legislative, policy, market access and public law litigation…

Grant Castle is a partner in London and Dublin practicing in the areas of EU, UK and Irish life sciences regulatory law. He supports innovative pharmaceutical, biotech, medical device and diagnostics manufacturers on regulatory, compliance, legislative, policy, market access and public law litigation matters in the EU, UK, and Irish Courts.

He is one of the Co-chairs of Covington’s Life Sciences Industry Group and is Head of Covington’s European Life Sciences Regulatory Practice.

Grant regularly advises on:

  • EU and UK regulatory pathways to market for pharmaceuticals and medical devices, including in vitro diagnostics and on associated product life cycle management;
  • Pharmaceutical GxPs, including those governing pharmacovigilance, manufacturing, the supply chain and both clinical and non-clinical research;
  • Medical device CE and UKCA marking, quality systems, device vigilance and rules governing clinical investigations and performance evaluations of medical devices and in vitro diagnostics;
  • Advertising and promotion of both pharmaceuticals and medical devices; and
  • Pricing, reimbursement and market access for both pharmaceuticals and medical devices.

Grant also handles procedural matters before EU, UK and Irish regulators and UK and Irish market access bodies, where necessary bringing judicial reviews for his life sciences clients before the EU, UK and Irish Courts.

Chambers UK has ranked Grant in Band 1 for Life Sciences Regulatory for the last 18 years. He is recognized by Chambers UK, Life Sciences as “excellent,” “a knowledgeable lawyer with a strong presence in the industry,” who provides “absolutely first-rate regulatory advice,” according to sources, who also describe him as “one of the key players in that area,” whilst Chambers Global sources report that “he worked in the sector for many years, and has a thorough understanding of how the industry ticks.” He is praised by clients for his “absolutely first-rate” European regulatory practice. Legal 500 UK notes that he is “highly competent in understanding legal and technical biological issues.”

Photo of Robin Blaney Robin Blaney

Robin Blaney is a partner in the firm’s Life Sciences practice. He advises pharmaceutical, biotechnology, medical device and cosmetic manufacturers and trade associations on a wide range of regulatory, compliance, transactional and legislative matters, as well as the full range of commercial agreements…

Robin Blaney is a partner in the firm’s Life Sciences practice. He advises pharmaceutical, biotechnology, medical device and cosmetic manufacturers and trade associations on a wide range of regulatory, compliance, transactional and legislative matters, as well as the full range of commercial agreements that span the product life-cycle in the life sciences sector. His expertise includes clinical trial agreements, manufacturing and supply agreements, distribution and other marketing agreements, regulatory services agreements, and tenders. He has particular experience structuring and documenting EU pharmaceutical distribution arrangements and transitional arrangements relating to product acquisitions. Robin writes and speaks regularly on subjects such as medical device regulation, pharmacovigilance and clinical trials.

Photo of Brian Kelly Brian Kelly

Brian Kelly is a partner in the European Life Sciences group and also co-chair of Covington’s Global Food Industry Group. Brian’s practice focuses on EU food and drug regulatory law, public and administrative proceedings, EU procurement advice and challenges, internal investigations, European Union…

Brian Kelly is a partner in the European Life Sciences group and also co-chair of Covington’s Global Food Industry Group. Brian’s practice focuses on EU food and drug regulatory law, public and administrative proceedings, EU procurement advice and challenges, internal investigations, European Union law, and product liability and safety. The Chambers Europe Guide to the legal profession lists Brian as part of our “world-class [regulatory and public affairs] team and describes him as a notable practitioner who is “very ambitious, thorough with a sharp intellect”. The Chambers UK Guide quotes clients saying: “his communication and work ethic stand out, he is very hard-working and dedicated when it comes to his cases.”

Brian’s advice on general regulatory matters across all sectors includes borderline determinations, food classifications, tissue and stem cell regulation, adverse event and other reporting obligations, manufacturing controls, labeling and promotion, pricing and reimbursement/procurement, procurement/tenders (including emergency use tenders, EU-wide tenders, Covid-19-related tenders), product life cycle management (foods and medicines), nanotechnology, and anti-bribery and corruption advice. Brian has also been advising on UK and European “Brexit” related issues including tariffs.

Brian has also advised and co-ordinated international projects on advertising/promotion, clinical research, data protection, the regulatory status of borderline products, food/cosmetic ingredient reviews and advises on regulatory aspects of corporate/commercial deals, particularly regulatory due diligence.

Brian is also experienced in representing clients in administrative and enforcement proceedings before regulatory authorities and in the UK and EU courts.

Brian is an honorary lecturer at University College London.

Photo of Raj Gathani Raj Gathani

Supporting clients in the pharmaceutical, healthcare, medical device and consumer products sectors, Raj Gathani’s practice is built around EU and UK regulatory and strategic advice.

Increasingly, Raj concentrates on post market-launch projects, such as advising on advertising compliance, communications, interactions with healthcare professionals…

Supporting clients in the pharmaceutical, healthcare, medical device and consumer products sectors, Raj Gathani’s practice is built around EU and UK regulatory and strategic advice.

Increasingly, Raj concentrates on post market-launch projects, such as advising on advertising compliance, communications, interactions with healthcare professionals and patients, pricing controls and reimbursement strategies particularly in the UK and the Republic of Ireland.

Healthcare, its structure and delivery are specialist practice areas for Raj, particularly having operated healthcare and pharmacy businesses for eight years prior to joining the firm. This experience enables Raj to provide in-depth advice to healthcare clients –particularly those in the digital health space – as well as other life sciences companies whose work engages medical practice, dispensing and health-services rules.

Photo of Dan Spivey Dan Spivey

Dan Spivey is an associate in the Life Sciences Regulatory team. Dan advises clients in the pharmaceutical, healthcare, medical device, and food and beverage sectors on a range of regulatory matters.

Tamzin Bond

Tamzin Bond is a Trainee Solicitor who attended BPP School of Law. Prior to joining the firm, Tamzin completed her Ph.D in Chemistry from Imperial College London.