The Future Of UK Pharmaceutical Best Practices --By Lincoln Tsang and Silvia Valverde, Arnold & Porter LLP

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1 Published by Life Sciences Law360 on January 26, Also ran in Health Law360. The Future Of UK Pharmaceutical Best Practices --By Lincoln Tsang and Silvia Valverde, Arnold & Porter LLP Law360, New York (January 26, 2015, 1:46 PM ET) -- As focus on the transparency of 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 Nov. 26 of the 2015 edition of the Association of the British Pharmaceutical Industry (ABPI) Code of Practice represents the agreed best industry practice in the U.K. The new code was agreed at the half yearly general meeting of the ABPI on Nov. 20 and came into operation on Jan. 1, 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 existing 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 of reducing administrative burdens and improving 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 New Terms Introduced in the Code The term appropriate administrative staff has been replaced by other relevant decision makers.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 health care 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 National Health Service managers, local government officers and members of health and wellbeing boards so that some of the code requirements are applicable to those persons. The term health care organization, 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 organizations of any size such as those consisting of only one health professional or relevant decision maker, however, it is noted that these healthcare organizations 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. New Clauses Clause 18 is now divided in three clauses to improve clarity. These new clauses cover: (a) medical and educational goods and services (MEGS), (b) joint working and (c) relationships and contracts with certain

2 organizations. Although the requirements have not varied, the position and 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 health care organizations 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. Digital Media 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 emphasizes 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 recognizes 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 health care organizations are directed at the implementation of the pre-existing requirements. For example it has been made clear that:

3 MEGS must be disclosed as they are either donations, grants or benefits in kind to health care organizations; the term health professional in the context of disclosure includes any employee of a pharmaceutical company whose primary occupation is that of a practicing health professional, which means that transfers of values to such individuals should be disclosed; 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 health care organizations must be disclosed on a per activity basis; and transfers of value to a health professional made indirectly via a health care organization 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 nonmember 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 Nov. 24, The U.K. template for disclosure follows closely the EFPIA template. The small differences introduced are 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 spending against a health professional, the system will generate an automated informing the health professionals. Health professionals will have the opportunity to send s 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 Implications 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 U.K., such collection and use is governed by the Data Protection Act 1998 (DPA). Under the DPA, transfer of value data published in conjunction with the name of an individual is considered personal data. The processing of such data (which is widely defined under the DPA and covers, for example, simply storing personal data) is only permitted if the processing is fair, lawful and at least one of the conditions set out in Schedule 2 of the DPA applies (i.e., the first data protection principle ). In the context of a transfer of value to a health professional, the conditions in Schedule 2 of the DPA include: the health care provider has consented to the processing; the processing is necessary for compliance with any legal obligation that applies to the pharmaceutical company (other than one imposed by contract);

4 the processing is necessary for the performance of a contract, which the health professional has entered into (or it is necessary because the health professional has asked for something to be done so they can enter into a contract); the processing is necessary to protect the health professional s vital interests ; the processing is necessary for administering justice or for exercising statutory, governmental or other public functions; the processing is necessary for the purposes of legitimate interests pursued by the pharmaceutical company or by the third party or parties to whom the data are disclosed, except where the processing is unwarranted in any particular case by reason of prejudice to the rights and freedoms or legitimate interests of the health professional in question. In the absence of a valid consent from a health professional, it is questionable whether a pharmaceutical company would be able to rely upon any of the above in order to lawfully carry out the public disclosures required by the code. First, such disclosure requirements are set out in the code and do not constitute a legal obligation. Second, the obligation on pharmaceutical companies to document and publicly disclose certain transfers of value is not strictly necessary for the performance of any contract to which the health professional might be a party. Third, the vital interests condition only applies in cases of life or death, such as where an individual s medical history is disclosed to a hospital s accident and emergency department. Fourth, it seems unlikely (although not impossible) that U.K. courts and authorities would see the legitimate interests of the pharmaceutical industry in implementing transparency regarding its relationships with a health professional as overriding the individual interest of the health professional in protecting his or her privacy. Accordingly, assuming that personal data is otherwise processed fairly and lawfully, obtaining valid consent from health professionals (i.e., consent that is informed and freely given) is the only risk-free way for pharmaceutical companies to ensure that transfer of value data can be published without breaching the first data protection principle. As a result, if a health professional subsequently revokes his or her consent, the pharmaceutical company in question would not be able to publish the transfer of value data in conjunction with the name of the relevant health professional (otherwise there would be a risk of breaching the DPA). Further, unless the data is required for other fair/lawful purposes and one of the conditions set out in Schedule 2 of the DPA applies (for example, if a copy of the data is needed for the pharmaceutical company s internal accounting purposes), the pharmaceutical company would be required to delete the data. It is important to note, however, that revoking consent does not have retroactive effect. This means that it will not make previous data processing that was based on the original consent unlawful. However, revoking consent should, in principle, prevent any further processing of the data subject s data unless that processing can be justified by another legal ground. 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.

5 Transparency Implications for the Future The first disclosure will be available by July 1, This will cover the payments made in The data together with the methodological notes, prepared by the companies explaining the treatment that they have made of certain transfer of value data, will be freely accessible and downloadable as a spreadsheet 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 U.K. among health professionals, industry and regulators. It will be interesting to see how far this culture materializes 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 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 toward this end. [1] The Human Medicines (Amendment No.2) Regulations 2014 (SI 2014/1878). Lincoln Tsang is a partner and Silvia Valverde is an associate in Arnold & Porter's London office. Tsang served as a senior official of the U.K. Regulatory Authority for nearly 13 years, where he was head of biotechnology and biologicals. The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.