New SOP TRAINING

1. New SOP TRAINING AUGUST 2012

2. SOPs to be trained • Customer Requests for Sponsorship (SM012) • Medical Educational Goods and Services (MS024)

3. New SOP SM012 Customer Requests for Sponsorship

4. Scope • This SOP describes the process for the proposal and approval of sponsorship requests. Sponsorship is: • Sponsorship is the provision of money by Chiesi which is non-promotional and unconditional in nature given to facilitate a medical/educational meeting or service with no involvement by Chiesi. MEGS are: • MEGS are services funded and provided by Chiesi who then have responsibility for the item or event. These remain non promotional and unconditional. Examples: • Medical Service (e.g. nurse audit programme) • Educational Goods (e.g. purchase of a medical book for a department) • Educational Service

5. Clarification • The term “sponsorship” is also used by HCPs when requesting support for a meeting in the form of payment for stand space. • Although they may use the term “sponsorship”, this is not sponsorship and no approval by the Medical Department is required. • The process to follow is part of the representatives process (payment can be made, to an institution, and processed through expenses, subject to RBM approval if the request exceeds £150). • A general principle of Sponsorship is that Chiesi provides the sponsorship but has no presence or involvement in the meeting or activity. • If we have a presence, it should be considered if it is actually a stand meeting. • If we have an involvement it should be considered if it is actually a Chiesi meeting. • If there is any doubt, the medical department can provide advice.

6. ABPI Requirements Clause18.1: • No gift, benefit in kind or pecuniary advantage shall be offered or given to members of the health professions or to administrative staff as an inducement to prescribe, supply, administer, recommend, buy or sell any medicine Clause 19.3: • When meetings are sponsored by pharmaceutical companies, that fact must be disclosed in all of the papers relating to the meetings and in any published proceedings. The declaration of sponsorship must be sufficiently prominent to ensure that readers are aware of it at the outset. Clause 19.4: • Pharmaceutical companies must make publicly available financial details of sponsorship of UK health professionals and appropriate administrative staff in relation to attendance at meetings organised by third parties. Sponsorship in this context includes registration fees, costs of accommodation (both inside and outside the UK) and travel outside the UK.

7. NOT permitted requests • It is not permitted to sponsors requests where there is a pecuniary advantage to the HCP i.e. where the HCP would achieve a greater qualification such as general nursing, pharmacy or medical qualification • It is not permitted to sponsor requests where the HCP already receives funding for the government to perform such activities or it is part of the GP contract. Examples are the support for CPR training, Chaperone Training or Fire Training. • It is not permitted to sponsor requests where there is no direct patient benefit such as self-defence courses or sponsorship of a HCPs professional membership fees i.e. fees for the Royal College of Physicians. • It is not permitted to make a payment directly to a HCP. The payment must be made to either a department fund or directly to the institution/provider i.e. in the case of the Asthma Diploma paid to Education for Health. • In the case where there is no third party or department fund, the payment must be made to the HCP only on provision of an original receipt/invoice showing that the activity has taken place i.e. payment for a flight.

8. Permitted Requests • Attendance at Scientific Meetings where a HCP can increase their medical and scientific knowledge. Sponsorship can include part or full sponsorship to cover travel (economy class), accommodation (not 5 star) and conference registration fees. • Chiesi will support local and independent scientific/educational meetings such as a local Respiratory Network or a practice nurse network meeting etc. • Chiesi will support specific educational training courses that will enhance patient care i.e. the Asthma Diploma run by Education for Health. It is important however that the course does not result in a significant qualification for the HCP that would result in a pecuniary benefit such as a formal degree qualification.

9. Process for Sponsorship Representative receives request from HCP Rep cannot promise sponsorship – requires medical approval Representative completes Sponsorship Approval form Review and approval by RBM After local review, submit for HO approval sponsorship@chiesi.uk.com Medical Review and Approval “For the avoidance of doubt, Chiesi neither seeks nor expects you or those with whom you practice to purchase, prescribe, administer, recommend or supply any Chiesi medicinal product in connection with the funding here provided for”. Letter to HCP with sponsorship

10. Declaration of sponsorship • Materials relating to activities/meetings sponsored by Chiesi must clearly state that the meeting is sponsored by Chiesi. • Details of the sponsorship must be given i.e. accommodation, travel and subsistence costs and must be specific i.e. “Meeting sponsored by Chiesi for the funding of printing of meeting materials”.

11. Declaration of funding • The sponsorship request & recipient is logged as per SOP MS026 - Reporting of payments to UK Healthcare Professionals • The payments section of the Sponsorship Approval Form is completed and the form is passed to finance for processing • Finance will process the payment &code it to xx342 or xx344. In these codes: • xx denotes which department the budget is assigned to • 342 denotes sponsorship to attend a scientific meeting • 344 denoted other sponsorship • 347 denotes travel, accommodation and subsistence expenses • In January Finance will produce an Excel report which will list all payments made and assigned to the codes 342, 344 or 347. • Information will be made publically available no later than March 31st of that year on the Declarations Section of the Chiesi UK website www.chiesi.uk.com.

12. Sponsorship Approval Form

13. New SOP MS024 Medical Educational Goods and Services

14. Scope • This SOP describes the process for the proposal and approval of MEGs requests. Sponsorship is: • Sponsorship is the provision of money by Chiesi which is non-promotional and unconditional in nature given to facilitate a medical/educational meeting or service with no involvement by Chiesi. MEGS are: • MEGS are services funded and provided by Chiesi who then have responsibility for the item or event. These remain non promotional and unconditional. Examples: • Medical Service (e.g. nurse audit programme) • Educational Goods (e.g. purchase of a medical book for a department) • Educational Service • Must be provided Nationally

15. Types of MEGS Medical Goods • Where the MEGS is the provision of a piece of medical equipment, the letter of agreement must include details of who has the responsibility for ensuring the correct use and maintenance of the equipment. Medical Service • Where the MEGS is the provision of a medical service such as a nurse review service, a letter of agreement and a written protocol must be put in place. Medical Education • Where the MEGS is the delivery of an education service, the letter of agreement must stipulate who is responsible for delivering the content of the education and the education itself. • Letter to HCP must be signed by HCP so that he/she agrees to the terms of the agreement and returns one signed copy for our files • This would be required if the MEGS was an educational service or a Medical Service such as a nurse audit but would not be required if it was, for example, a text book.

16. ABPI Requirements Clause 18.1: • No gift, benefit in kind or pecuniary advantage shall be offered or given to members of the health professions or to administrative staff as an inducement to prescribe, supply, administer, recommend, buy or sell any medicine Clause 18.4 • Medical and educational goods and services which enhance patient care, or benefit the NHS and maintain patient care, can be provided. • They must not be provided to individuals for their personal benefit. • Medical and educational goods and services must not bear the name of any medicine but may bear the name of the company providing them.

17. Role of the Representative • If medical representatives provide, deliver or demonstrate medical and educational goods and services then this must not be linked in any way to the promotion of products. • In order to comply with this stipulation the representative must not carry out both activities at the same visit. • If, during a promotional visit by a representative, a change in medication to one of the company’s products is agreed, the representative may not then offer a therapy review service to facilitate the change as this would be seen as a way for the company to ensure that the agreed change would in fact be made.

18. Role of the Company • The involvement of a pharmaceutical company in such activities must be made clear to relevant health professionals and/or administrative staff receiving the service. • The involvement of a pharmaceutical company in therapy review services should be made clear to patients. • A recipient of a service must be provided with a written protocol to avoid misunderstandings as to what the recipient has agreed. • The identity of the sponsoring pharmaceutical company must be given. • These materials and any others used in the provision of a service must be certified. • The Code recommends that Companies inform relevant parties such as NHS trusts, health authorities, health boards and primary care organisations of their activities where appropriate. This is particularly recommended where companies are proposing to provide medical and educational goods and services which would have budgetary implications for the parties involved.

19. Process for MEGs Representative receives request from HCP Rep cannot promise support – requires medical approval Representative completes MEGs Approval form Review and approval by RBM After local review, submit for HO approval MEGs@chiesi.uk.com Medical Review and Approval MEGs Approval form Terms of the agreement must be specifically agreed by both parties Letter of agreement to HCP

20. Additional SOPs

21. Additional new SOPs • Donations and Grants (MS028) • Interactions with Patient Organisations and Charities (MS025) • Engagement of HCPs as Consultants (MS029) If you receive any requests from customers related to donations, grants, use as a consultant or are asked to support a patient Organisation of Charity, please send these requests directly to the Medical Department for their review. Please note: • For engagement of a HCP as a speakers at a meeting, SOPs SM017 Speaker Meetings Organised by the Field Force must be followed.

22. Thank you