ABPI Disclosure Methodological Note. March 2016

Transcription

1 March 2016

2 Introduction In line with the European Federation of Pharmaceutical Industries and Associations (EFPIA) Disclosure Code (as implemented by the Association of the British Pharmaceutical Industry (ABPI) in the UK), Roche Products Limited (hereafter referred to as Roche) is the Roche affiliate responsible for the public disclosure of any Transfers of Value (ToVs) to Healthcare Professionals (HCPs), including Other Relevant Decision Makers (ORDMs) and Healthcare Organisations (HCOs) in the UK. 2

3 Background Previously, Roche (as with all pharmaceutical companies) was required to make an annual disclosure of payments to HCPs in an aggregated format (total spend in the year and total number of HCPs whom provided a service) and grants to HCOs on its UK website. The new system increases the level of transparency and now all information regarding ToV made to HCPs/ORDMs and HCOs will be made public on the ABPI platform rather than on individual company websites. From 2016 certain payments will be made public at an individual level meaning that anyone can search for an HCP, ORDM or HCO and potentially see all applicable payments made to that individual/organisation during the previous calendar year. By 1 July 2016, the payments and other ToVs made by Roche and other pharmaceutical companies to HCPs, ORDMs and HCOs will be publicly disclosed by the ABPI on an individually identifiable basis, unless there is a legal reason for such data not being individually identifiable. This reason might be a situation where an individual HCP or ORDM chooses to withdraw or decline consent for such public disclosure under the UK s data protection legislation or where such information relates to the planning or conduct of certain Research and Development (R&D) activities (see page 8). Roche is committed to ensuring that the relationship between the industry and HCPs, ORDMs and HCOs is better understood. Roche welcomes this increased transparency and believes it to be in the best interests of the pharmaceutical industry, the NHS and ultimately patients. This document outlines the methodology and definitions used by Roche in relation to such disclosures. What is disclosure? Disclosure means the release of information. Details of payments made to UK HCPs, ORDM s and HCOs will be submitted by Roche and published on a central platform which can be accessed from the ABPI website. This information is being made public to help people understand the interactions between HCPs, ORDMs and HCOs and the pharmaceutical industry. Why is transparency important? It is essential that patients have confidence that the relationship between their HCPs, ORDMs and HCOs who prescribe, purchase, recommend or supply their medicine, and the industry that makes the medicines they rely on, are open and easy to understand. Why does Roche work with external bodies and individuals? Roche frequently partners with health experts with a view to developing pragmatic solutions that will help patients across the UK access highly innovative medicines and address the current challenges facing the healthcare sector. We believe all patients, no matter where they are or what condition they have, should benefit from available potentially life-changing medicines and are therefore fully committed to finding the best solutions in collaboration with all parties. Advice and counsel from HCPs including ORDMs and HCOs has enabled research-based companies, like Roche, to deliver numerous innovative medicines, re-writing the pathway of many diseases. As with any professional group providing counsel, it is fair and appropriate to remunerate HCPs including ORDMs and HCOs for their time and expertise, in lieu of other lost earnings. Roche has robust processes for engaging with HCPs including ORDMs and HCOs, which are subject to internal scrutiny by the medical and commercial functions of the business. All engagements are planned in accordance with the ABPI code. 3

4 What is Roche s view on disclosure? Roche is committed to ensuring that the relationship between the industry and HCPs, ORDMs and HCOs is better understood by patients, the media and other stakeholders. HCPs and research-based companies like Roche work together to advance the understanding of different diseases and to support the development and delivery of new medicines for patients in need. We encourage HCPs and ORDMs to be willing to disclose ToVs they receive from the pharmaceutical industry via the ABPI platform. What is a Transfer of Value (ToV)? The term transfer of value means a direct or indirect transfer of value, whether in cash, in kind or otherwise, made, whether for promotional purposes or otherwise, in connection with the development or sale of medicines. A direct transfer of value is one made directly by a company for the benefit of a recipient. An indirect transfer of value is one made on behalf of a company for the benefit of a recipient or through an intermediate and where the company knows or can identify the recipient that will benefit from the transfer of value. The figures published in 2015 (for payments made in 2014) by Roche include both direct and indirect payments and other ToV. It should be noted that until December 31st 2015, Roche allowed for indirect payments to be made to individual HCPs or ORDMs via a service agency (for example, fees paid by third party agencies to HCPs or ORDMs for the provision of a service e.g. participation at an advisory board). These payments have been disclosed since 2013 (for payments made in 2012) at an aggregate level, as if the payment had been made directly by Roche to that HCP or ORDM. As of January 1st 2016 Roche no longer allows third parties to make payments to individual HCPs or ORDMs on behalf of Roche (with the exception of Contract Research Organisations (CROs) when these activities involve R&D.) Where a ToV has been non-monetary in nature (for example, the provisions of a virtual access pass to an international scientific congress), the calculation of the ToV is explained in the relevant section below. What activities need to be disclosed? The ABPI Code of Practice states that HCPs and ORDMs may be used as consultants and advisors, whether in groups or individually, for services such as: Speaking at and chairing meetings Training services Participation at advisory board meetings Participation in market research, when the company is aware of the identity of those participating, and where such participation involves remuneration and/or reimbursement of travel expenses. Sponsorship in relation to attendance at meetings, which is registration fees and the costs of accommodation and travel. As far as HCOs are concerned, benefits in kind, fees for services, contributions towards events and joint working need to be disclosed in addition to existing requirements to disclose grants and donations. Spend with HCOs on certain research and development activities (R&D) will be included in the aggregated R&D figure. Payments made to patient organisations will continue to be disclosed separately on the Roche website. What has Roche previously disclosed? Roche disclosed the aggregated amount of ToVs it incurred per year on UK HCPs and HCOs. These figures were reported and publicly available on the Roche UK website; Roche.co.uk 4

5 Why do we need UK HCP and ORDM consent? In line with the requirements of the Data Protection Act 1998, individual UK HCPs and ORDMs need to provide their consent for us to (i) process their personal data and (ii) disclose their personal data to the ABPI. What was the process for obtaining consent from UK HCPs and ORDMs to disclose 2015 ToVs? Roche sent letters to UK HCPs and ORDMs in late January 2016 providing an opportunity for them to check the accuracy of ToV data in 2015 and to consider whether they were happy to consent or wished to withdraw their consent. If they wished to withdraw their consent they were asked to Roche and told that any 2015 ToVs to them would then be included in an aggregated report. What if an UK HCP or ORDM consents then changes their mind? Each UK HCP and ORDM is entitled to withdraw their consent to disclosure at any time. They can send an to to notify us that they wish to decline giving their consent for the current calendar reporting period or following publication contact the ABPI via the ABPI platform. Where consent is withdrawn, Roche will adjust its disclosure to ensure that the total amount of all ToVs applicable to that UK HCP or ORDM becomes part of the disclosed aggregate figure and no longer identifiable against the individual UK HCP or ORDM. What happens at a European level? The transparency changes to the ABPI Code of Practice reflect changes at a European level. The European Federation of Pharmaceutical Industries and Associations (EFPIA) agreed the EFPIA Disclosure Code in June 2013 with requirements for public disclosure of certain transfers of value to individual HCPs and HCOs from 2016 for These changes affect 33 countries in Europe. 5

6 Which ToV are included in the figures published by Roche? Categories disclosed against individual HCPs or ORDMs in 2015 Description of ToV HCPs/ORDMs - Fees for service and consultancy and associated related expenses agreed in the fee for service or consultancy contract HCPs/ORDMs - Associated expenses HCPs/ORDMs - Payments made to consultants in relation to market research where the identity of those participants is known to Roche HCPs/ORDMs - Sponsorship of HCPs/ORDMs for attendance at meetings Roche pays fair market value (FMV) fees for the provision of services provided by HCPs/ORDMs (either directly or indirectly). These types of services may include; chairing or speaking at meetings and, participating in advisory boards. This service provision is documented and agreed via a consultancy agreement and the fees and associated expenses documented in the agreements are disclosed. Notes: 1) If a meeting was cancelled after an HCP or ORDM had already spent time preparing for the meeting then this preparation time would be reimbursed and hence disclosed. The expenses may include; travel expenses, accommodation rates (may include dinner, bed and breakfast rates or room only depending on the engagement) and other associated expenses claimed by the service provider, for example parking and any additional and appropriate subsistence. Notes: 1) Expenses already incurred and reimbursed for an event that is later cancelled (e.g. economy rail fare to attend a speaker meeting) will be disclosed. 2) When Roche engages with an HCO to provide the services of an HCP, any fee for service is paid directly to the HCO, however expenses claimed by the HCP will be reported against the individual providing consent is given. Roche did not make any direct payment to HCPs/ORDMs for market research where the identity of such HCP/ ORDMs was known to Roche in For blind market research where Roche is not made aware of the identity, of the individuals involved and any payments made to them, these have not been disclosed. Roche does not sponsor individual HCPs/ORDMs to attend third party organised meetings. Occasionally other members of the Roche group may sponsor individuals for their attendance and the associated registration fees and travel expenses are disclosed accordingly. Categories disclosed against HCOs in 2015 Description HCOs - Sponsorship agreements with HCOs/third parties appointed by HCOs Roche discloses all payments made to medical associations, healthcare organisations, etc. in relation to meetings. This includes direct funding such as sponsorship fees or the right to have an exhibition stand, and indirect support such as providing a logistics agency or subsidising the cost of registration fees. For the purposes of reporting Roche has included third parties (e.g. British Society of Haematology) in the definition of an HCO. 6

7 HCOs - Joint working HCOs Preceptorship/Clinical experience HCOs - Donations/grants HCOs/HCPs/ORDMs Medical and Educational Goods and Services ( MEGS ) Joint working arrangements are situations where, for the benefit of patients, one or more pharmaceutical company and the NHS pool skills, experience and/or resources for the joint development and implementation of patient- centred projects, and share a commitment to successful delivery. Where a Roche employee is working on a project and is included in the calculation of value, this value is calculated based on their daily rate according to their salary. Further information on Joint Working projects Roche is currently involved in can be found at Roche.co.uk. Expenses paid to HCOs for the arrangement of a preceptorship event (e.g. medical education) are reported as fee for service against the relevant HCO. Roche may make a financial contribution in response to a request which is destined for an independent, specific activity or purpose, and which must benefit patients and/or public health, and must only be provided for the purpose of research, education and/or information. Grants may be provided to HCOs and a clear arm s length arrangement must be in place. Note that these have previously been disclosed on the Roche website. This term covers the non-promotional provision of goods and/or services which directly enhance patient care, or benefit the NHS and maintain patient care. Within Roche the term MEGS applies to Goods and Services and does not include Grants. Roche did not carry out any activities of this type in Disclosure of Research and Development Transfers of Value Research and Development (R&D) ToVs are disclosed at an aggregate level (i.e. total spend with all involved HCPs/ ORDMs/HCOs added together without specifying individuals who have been paid). Items included: Pre-clinical research and clinical research (includes Investigator Sponsored Research (ISR)) Non-interventional studies Advisory boards and consultancy services in relation to clinical research Real world data studies and Health Outcomes research Fees for service to HCPs, ORDMs and HCOs in relation to study sites (including where these fees have been made by CRO on behalf of Roche) Travel and accommodation in relation to a fee for service contract. Items not included: Overhead cost (including CRO fees) and Materials (such as study medication, injection kits, etc.) How do Roche manage consent and data privacy? Informed consent needs to be obtained from UK HCPs, ORDMs and HCOs for the general processing of their data and this is done using standard legal wording in the applicable consultancy or service agreements signed before the relevant activity starts. 7

8 In addition, the UK Data Protection Act 1998 (DPA) requires Roche to gain the consent from individual UK HCPs and ORDMs prior to disclosing ToVs on an individual named basis to the ABPI. This consent is entirely voluntary and can therefore be withheld or withdrawn at any time. Consent is not required from UK HCOs prior to disclosing ToVs to the ABPI on an individual UK HCO basis as the DPA applies to the protection of personal data only. At the time of disclosure to the ABPI, if consent has not been given (or is withheld or withdrawn) by a UK HCP or ORDM, the related ToVs for such UK HCP or ORDM will be included in Roche s aggregated (non-identifiable) disclosure total. If a UK HCP or ORDM then wishes to withdraw their consent to identifiable disclosure, Roche will notify the ABPI and changes will be made to Roche s disclosure report with the affected ToV then being removed as an individually identifiable disclosure and then reported under the aggregated (non- identifiable) disclosure. Roche does not allow for any partial disclosure. In other words, UK HCPs and UK ORDMs can only consent to all ToVs reported by Roche being disclosed on an individually identifiable basis. If a UK HCP or UK ORDM does not wish to consent, all applicable ToVs reported by Roche to that UK HCP or UK ORDM will be disclosed in aggregate (non-identifiable format). UK HCP and ORDM consent validity and recording of consent status: Disclosures on the ABPI platform will stay publically available for a minimum of three (3) years from the time of publication. An individual UK HCPs or ORDMs consent with Roche is considered to be valid for a period of 3 reporting years unless they withdraw their consent during this time. Roche will log consent status in its customer relationship management system as Consent Received or Consent Declined. Private companies Where an UK HCP or ORDM runs a private company, (where he/she is the only employee of the corporation) Roche has treated this as if it were an individual UK HCP or ORDM and has disclosed against the individual. Where an organisation is principally made up of a group of HCPs, but where the ToV cannot be reasonably ascribed to an individual HCP within the organisation, this organisation has been designated an HCO and the ToV disclosed accordingly. Financial considerations Payments to charity On occasion, a UK HCP or ORDM who has provided a service to Roche may ask for their fee to be paid to a charity. Roche policy does not allow this and Roche insists that all payments are made directly to the UK HCP or ORDM concerned and hence classed as a ToV to the individual UK HCP or ORDM concerned. Cross Border Payments Roche discloses ToV based on the HCPs country of practice. If the HCP practices in more than one country, Roche will select one to be the primary country and disclose all ToV to him/her in that country. ToVs made by affiliates of Roche for interactions with an UK HCP or ORDM are captured in a Roche Group system (ihcp) and will be disclosed by the Roche affiliates responsible for reporting in the HCPs primary country. In case of multi-year cross-border engagements, the contracts effective date (attendance start date is noted in ihcp) and the subsequent first days of each calendar quarter are considered as ToV dates, to which the total engagement ToV is split. 8

9 Acquisition of InterMune Following the acquisition of the InterMune group of companies by the Roche Group, the InterMune business in the UK was transferred to Roche with effect from 1st January Accordingly, any 2015 ToVs relating to engagements of UK HCPs, HCOs or ORDMs by InterMune were made by Roche directly and will be accordingly declared by Roche. Co-promotion projects Roche and Chugai Pharma UK Limited (Chugai) currently co-promote a Prescription Only Medicine (POM). For this and any other situation where Roche jointly markets a product with another pharmaceutical company, Roche will only declare those ToVs made directly by Roche. ToVs made by any co-marketing partner (including Chugai) will be disclosed separately by that organisation. Handling of value-added tax (VAT) and withholding tax In general, Roche defines ToV as cost to Roche and hence VAT is excluded from the reported ToVs. Following the same principle, withholding taxes paid by Roche for a ToVs provided to an HCP/ORDM/ HCO would be included in the reported ToVs. Two exceptions from the above rule exist: For indirect payments related to events, VAT is typically not recoverable for Roche and the company s systems do not capture VAT separately. In this instance the reported ToV will include VAT; and The same applies to actual cross-border spend captured in ihcp, for which no VAT is readily identifiable and gross amounts often include a blended VAT for expenses across different countries and VAT levels. In this instance, reported ToV will include VAT. Transactions and currency conversions All ToVs are disclosed in Roche s local currency ( GBP). Any ToV made in foreign currency is converted using the daily exchange rate rates embedded into the Roche accounting systems at the time the ToV is applied. Timing Roche discloses to the ABPI all ToV it (and its affiliates) made between 1 January and 31 December of one year by 31 March the following year (for publication by the ABPI by end of June of the same year). A ToV is considered to be made when the transfer is complete (e.g. when an amount is paid or a benefit received). For example: If a contract is signed on 1 October 2015 but the payment is made on 15 January 2016, the disclosure will be treated as a 2016 ToV and disclosed to the ABPI by 31st March 2017 for publication by end of June In the case of a ToV captured in ihcp the attendance/activity date will be classed as the date of the transfer of value. For any multi-year contracts the ToV are disclosed by reference to the year the payment or benefit was provided to the HCP/ORDM/HCO. 9