Disclosure of Transfers of Value to Health Care Professionals Stirling Anglian Pharmaceuticals Limited Methodological Note 2015 Hillington Park Innovation Centre 1 Ainslie Road Hillington Park Glasgow G52 4RU 1. Introduction. As a non-member company that has agreed to abide by the ABPI Code of Practice since 18 May 2015, Stirling Anglian Pharmaceuticals Limited has registered to disclose transfers of value to Health Care Professionals for the calendar year 2015. The aim of this methodological note is to define the way in which Stirling Anglian Pharmaceuticals has approached this task and to provide assurance that disclosure is robust and takes due account of the ABPI Code of Practice and requirements related to the handling of personal information. 2. Stirling Anglian Pharmaceuticals acknowledges the content of the ABPI Code of Practice 2016 and in particular Clause 24 on transfers of Value and the definitions contained in Clauses 1.4 and 1.9 of the Code. Stirling Anglian also notes that the Code, as a whole, applies to this process. 3. Stirling Anglian Pharmaceuticals endorses the ABPI position on disclosure of payments and encourages disclosure by HCP s. It is recognised that positive consent to disclose is required and we have taken steps to provide HCPs with a number of opportunities to provide such consent both by written and electronic communication. Stirling Anglian has accepted both electronic and written consent and holds records from each HCP as to their consent to disclose. 4. Stirling Anglian Pharmaceuticals is a small and relatively new pharmaceutical company founded in 2013. Marketing authorisations for its first products were granted in May 2014. Marketing is restricted to the UK and to Malta (no payments have been made to HCO s and HCP s in Malta). While licenses are held for a number of European countries no payments have been made to HCPs or HCOs in these countries. 5. Tax Considerations. All payments made by Stirling Anglian are gross payments and no deductions are made by the company for tax or National Insurance. This remains the responsibility of the recipient. Where VAT is charged in an invoice or a VAT number is shown, the invoiced amount includes VAT at the current UK rate. 6. Currency. All payments made by Stirling Anglian to HCPs and HCOs in 2015 were in pounds Sterling. Thus there are no issues with currency conversion rates. Registered Office: Hillington Park Innovation Centre, 1 Ainslie Road, Hillington Park, Glasgow G52 4RU Registered in Scotland Company No: SC453258
7. Cross-Border Payments. Stirling Anglian has made no cross-border payments in 2015. 8. Multi-Year Contracts Stirling Anglian Pharmaceuticals engages HCPs and HCOs on a per activity basis. There are currently no multi-year contracts between HCPs and Stirling Anglian. 9. Over-the-counter transfers of value. Stirling Anglian did not provide any over-the-counter transfers of value in 2015. 10. Medical Device transfers of value. There have been no medical device transfers of value made by Stirling Anglian in 2015. 11. In the view of Stirling Anglian Pharmaceuticals, we believe the disclosures made are consistent with the ABPI Code and Data Protection legislation. The details given are current to the best of our knowledge. 12. We have made the following definitions: Sponsorship this is defined as any payment made to a HCP or HCO that supports the holding of a meeting for educational or other purposes (such as an HCO promulgating policy or items of clinical interest). This includes provision of payments to HCOs to allow promotional activity to be associated with such meetings (e.g. promotional stands). Where a meeting is sponsored by a number of companies, only the Stirling Anglian contribution is noted as information from other companies is not available to us. This is shown as a transfer of value to the HCO sponsoring the meeting. Further, the definition of sponsorship includes any instance where Stirling Anglian has contributed, in whole or in part, to the costs of registration, travel and accommodation of a HCP at any meeting or conference. This is shown, with consent, as a transfer of value to that HCP. Grant Stirling Anglian provides grants in a way consistent with Clauses 18 and 19. For operational purposes a grant would be provided for a specific pre-defined activity or service. Donation - a donation is defined as a payment or series of payments made to an organisation, usually a charity or a patient organisation to assist in the general activities of that organisation. Stirling Anglian would not specify the use to be made of such funds, nor would it request or require any specific report on the outcome of any activity for which funds were used. Stirling Anglian is mindful of the provisions of Clause 18.1 in this regard. No donations were made by Stirling Anglian to HCPs or HCOs in 2015.
13. Consent. Stirling Anglian has assumed consent for disclosure for all NHS HCOs this is consistent with the NHS policy of openness and transparency. This applies principally to Stirling Anglian sponsorship for meetings of Health Care Professionals. In this activity, Stirling Anglian is mindful of the provisions of Clause 22 in terms of venues, hospitality and the attendees of such meetings. For individual HCPs, Stirling Anglian requested specific consent to disclose by written or electronic response in February 2016. For non-responders, a further reminder was sent in early March 2016. This has resulted in a moderate degree of consent to disclose information. A small number have not responded despite two reminders and in these cases, consent cannot be assumed and payments to these HCPs have been placed in the aggregated section of the disclosure template. Consent for 2015 was based on a request to disclose all payments to each individual. For the future, Stirling Anglian is reviewing contracts with HCPs to ensure consent to disclosure forms part of the initial engagement process. 14. Non-monetary transfers of value. There have been no non-monetary transfers of value to HCPs or HCOs in 2015. 15. Working with other pharmaceutical companies. Stirling Anglian has no joint projects with other pharmaceutical companies within the reporting period. Thus no formal agreements have been required in 2015. We are mindful that where multiple sponsorship of an event occurs that the total amount of sponsorship could become problematic. We attempt to liaise with organisers to establish that total sponsorship for any event or meeting is consistent with the letter and spirit of the Code. 16. We hope that this methodological note provides assurance as to the steps taken by Stirling Anglian Pharmaceuticals to provide information in this first year of this disclosure process. We aim to build upon and refine our methodology in future years and to take a pro-active stance that encourages consent to disclosure at the point at which an activity is agreed with a HCP or HCO.
Annex 1 Text of letter to HCPs 19 February 2016 Disclosure of Payments to Healthcare Professionals Dear Sir/Madam As you may be aware, the Association of the British Pharmaceutical Industry ( ABPI ) has introduced a requirement that pharmaceutical companies should disclose payments made to Healthcare Professionals and Healthcare Organisations. As a company that has agreed to abide by the ABPI Code of Practice, we are required to provide details of these payments for calendar year 2015 by 31 March 2016. Further details of this important initiative are available on the ABPI website at: http://www.abpi.org.uk/our-work/disclosure/pages/disclosure.aspx. Stirling Anglian Pharmaceuticals made a payment to you during 2015 in connection with services you provided. The ABPI Code requires us to disclose details of this payment, including for example your name, role, address and the amount paid, using the template at the following link: http://www.pmcpa.org.uk/media/documents/abpi%20template%2024%20nov%202014.xls We are writing to you to seek your formal permission to disclose this information. If you do not wish your details to be included, your payment will be disclosed on an aggregate basis, excluding for example your name, address and role. We ask that you confirm your permission for us to disclose this information by Friday 26 February 2016, either by email to jenny.davis@stirlinganglianpharmaceuticals.com or by letter to Mrs Jenny Davis, Stirling Anglian Pharmaceuticals Ltd, Hillington Park Innovation Centre, 1 Ainslie Road, Glasgow G52 4RU. We have enclosed a proforma for your reply and a stamped addressed envelope to facilitate a postal response if this is your preference. Thank you Yours faithfully Philip McMenemy Medical Director
Stirling Anglian Pharmaceuticals Ltd ABPI Disclosure Proforma Name: Role: Healthcare Organisation: I acknowledge that I have received a payment from Stirling Anglian Pharmaceuticals Ltd for services rendered during calendar year 2015. I understand that such payments are subject to Disclosure via the ABPI central database. *I hereby consent to my details being disclosed by Stirling Anglian Pharmaceuticals. *I decline to give consent for my details to be disclosed but understand that my payment will form part of an aggregate amount disclosed by the company Signed: Date: *Delete as appropriate
Annex 2 Second letter requesting consent from HCPs 10 March 2016 Disclosure of Payments to Healthcare Professionals Dear «Salutation» «Surname» Stirling Anglian Pharmaceuticals is now at an advanced state of preparation to comply with the requirement to disclose payments to Healthcare Professionals in 2015. We wrote to you on 19 February 2016 asking for your consent to disclose information concerning a payment or payments made to you by the company in calendar year 2015. To date, we have not received a reply from you. I would be grateful if you would indicate your willingness to consent to full disclosure or if you wish to withhold such consent. A response by 17 March 2016 would be much appreciated. Yours sincerely Philip McMenemy Medical Director Stirling Anglian Pharmaceuticals Ltd
Stirling Anglian Pharmaceuticals Ltd ABPI Disclosure Proforma Name: Role: Healthcare Organisation: I acknowledge that I have received a payment from Stirling Anglian Pharmaceuticals Ltd for services rendered during calendar year 2015. I understand that such payments are subject to Disclosure via the ABPI central database. *I hereby consent to my details being disclosed by Stirling Anglian Pharmaceuticals. *I decline to give consent for my details to be disclosed but understand that my payment will form part of an aggregate amount disclosed by the company Signed: Date: *Delete as appropriate