As the focus on the transparency of the interactions between the pharmaceutical industry and its various stakeholders intensifies, it is key to adapt the internal company processes to reflect the latest industry’s best practices. The publication on 26 November of the 2015 edition of the Association of the British Pharmaceutical Industry (ABPI) Code of Practice (the Code) represents the agreed best industry practice in the UK. The new Code was agreed at the half yearly general meeting of the ABPI on 20 November and will come into operation on 1 January 2015.
The main changes are prompted by:
- The need to bring the Code closer to the Code of the European Federation for Pharmaceutical Industry Associations (EFPIA) on disclosure of transfers of value and the EFPIA code on the promotion of prescription only medicines;
- The increasing use of electronic media, including social media, for communication between pharmaceutical companies and other stakeholders; and,
- The need to simplify and clarify certain requirements in order to facilitate their implementation by the companies.
This simplification effort is consistent with the Better Regulation of Medicines Initiative (BROMI) developed by the Medicines and Healthcare Products Regulatory Agency (MHRA) with the aim to reducing administrative burdens and improve regulatory outcomes.
New Terms Introduced in the Code
- The term “appropriate administrative staff” has been replaced by “other relevant decision makers”. This change reflects better the intention of the Code to include persons who have a legitimate role in healthcare management and delivery but who are not health professionals. The aim is to cover those individuals that may influence the policy relating to administration, prescription, supply or use of medicines, such as NHS managers, local government officers, and members of health and wellbeing boards.
- The term “healthcare organisation”, which was not defined in the previous editions, is now defined in alignment with the EFPIA Disclosure Code. This definition is broadly worded to include organisations of any size such as those consisting of only one health professional or relevant decision maker, however, it is noted that these healthcare organisations composed by just one person are subject to the requirements of the Code regarding individual health professionals. This is to avoid the use of legal entities as a mechanism to circumvent the prohibitions regarding the provision of gifts and other benefits to individual health professionals.
Clause 18 is now divided in three clauses to improve clarity. These new clauses cover medical and educational goods and services (MEGS), joint working, and relationships and contracts with certain organisations. Although the requirements have not varied, the position and the controls regarding these activities are made clearer.
Interestingly, the proposal to introduce a new clause concerning the provision of product related service has been rejected at the general meeting of the ABPI. This clause had originally been drafted at the suggestion of the ABPI Review Group to allow services to be provided with a medicine when that service is not directly relevant to the medicine, e.g. a smoking cessation service linked to the purchase of a medicine for COPD. The implication is that the rules controlling the provision of services by pharmaceutical companies to healthcare organisations remain unchanged.
Simplified Prescribing Information
The changes to the Human Medicines Regulations 2012 made in October 1 to simplify the information required to be included in some advertisements to prescribers and suppliers of medicines are reflected in the new edition of the Code. It is now possible to use cross-references to the SmPC of the product to cover some of the requirements regarding prescribing information. In the case of digital materials, such as advertisements in electronic journals the prescribing information may appear via a link.
The 2015 edition of the Code seeks to clarify its application to materials stored and communicated through digital media. For example:
- It confirms that the black triangle symbol applies also to digital communications and explains how to use it;
- It reinforces the need to obtain prior permission from the recipient in advance of a web chat or other online chats; and,
- It emphasises the importance to ensure that the dynamic content of websites is certified both as a standalone item and within the context in which it appears.
Overall, this new edition recognises the value of electronic tools to facilitate compliance with the Code and the fact that companies are increasingly using electronic systems for internal approval of materials. The new Code simplifies the requirements for certification in the following ways:
- It is possible to certify printed material electronically using validated electronic signatures. When such material is to be printed, the final printed form only needs one of the two signatories to certify it before it is used.
- In arrangements where companies work together such as joint working projects or co-promotion, it is now permitted to have only two final signatories to certify on behalf of all the companies involved.
- Only the final documents for any joint working project has to be certified.
Disclosure of Payments
The changes introduced in relation to the disclosure of payments to health professionals and healthcare organisations are directed at the implementation of the pre-existing requirements. For example it has been made clear that:
- MEGS must be disclosed as they are either donations, grants or benefits in kind to healthcare organisations;
- The term “health professional” in the context of disclosure includes any employee of a pharmaceutical company whose primary occupation is that of a practising health professional;
- While the payments to health professionals may be aggregated in the template for disclosure on a category by category basis (e.g. annual amount of fees for services) the payments to healthcare organisations must be disclosed on a per activity basis; and,
- Transfers of value to a health professional made indirectly via a healthcare organisation should be disclosed once only, preferably as being a transfer to the health professional.
Central Platform for Disclosure
The disclosure of payments initiative is now facilitated by the creation of the ABPI central platform for disclosure. This is the online platform that companies must use to disclose the necessary information on payments. The use of the central platform is mandatory for ABPI members and companies who have signed up to comply with the Code but non-member companies would be allowed to use it. Companies are free to provide additional disclosure by providing the information on their own company websites.
Companies will be filling in the approved template and uploading it to the central platform through a secure system. The final template has now been adopted and it is available at the PMCPA website:ABPI Template 24 Nov 2014.
The UK template for disclosure shows small differences from the EFPIA template so that the data can be provided in a form suitable for the ABPI searchable database.
Health professionals will be able to check the data to be published about themselves in advance of publication. When a company allocates spend against a health professional, the system will generate an automated email informing the health professionals. Health professionals will have the opportunity to send emails back to the relevant companies with any concerns about their data. After the checking period the data will go live on the platform website.
Data Protection Issues
The applicability of the data protection rules to the collection and publication of the identified or identifiable personal data of the health professionals has been the subject of extensive discussions. In the UK, such collection and use is governed by the Data Protection Act 1998 (the DPA).
Under the DPA, health professionals retain the right to refuse to disclose their information and to seek correction of mistakes. Accordingly, the ABPI has indicated that member companies will not be in breach of their disclosure obligations if they work with a health professional who withdraws or refuses to give their consent to disclose. In these situations companies are expected to disclose these transfers of value in an aggregate form. It is for the companies to decide with which health professionals they will work and the terms of those arrangements.
Transparency in The Near Future
The first disclosure will be available by 1 July 2016. This will cover the payments made in 2015. The data together with the methodological notes will be freely accessible and downloadable as an excel file.
The various consultations and surveys conducted by the ABPI and other stakeholders indicate that there is a culture of transparency already established in the UK among health professionals, the industry and regulators. It will be interesting to see how far this culture materialises in practice and the proportion of health professionals that consent to disclose their individual interactions. The ABPI has indicated its intention to publish the number of health professionals that have not given their consent to disclose and the total amount paid to them. It will also be possible for health professionals to confirm that they have not received any payments from the industry.
It is intended that after the first two years an independent body representing the industry and the health professionals sector will host the central platform. It is hoped that other sectors of industry, such as medical devices, will come on board at some point in the future. However, at the moment there is not a clear movement towards this end.