CODE OF PRACTICE ON RELATIONSHIPS BETWEEN PIERRE-FABRE GROUP AND PATIENT ORGANIZATIONS

Transcription

1 CODE OF PRACTICE ON RELATIONSHIPS BETWEEN PIERRE-FABRE GROUP AND PATIENT ORGANIZATIONS - MAY

2 2 INTRODUCTION Any Pierre Fabre Grup s affiliate that is invlved in pharmaceutical prducts r medical devices develpment (hereinafter referred t as Pierre Fabre Affiliates) may cnclude arrangements with patient rganizatins. These interactins aim ultimately t help patients and cntribute t the ptimizatin f healthcare. Additinally, patients can play a rle in helping pharmaceutical develpment: incrprating their vice cntributes in particular t design better clinical study prtcls and allws t better define Target Prduct Prfiles. This cde f practice aims at cvering relatinships between Pierre Fabre Affiliates and patient rganizatins. It refers t the different Pierre Fabre labratries cdes 1,2 and cmplies with the cde f practice n relatinships between the pharmaceutical industry and patient rganizatins adpted by the Eurpean Federatin f Pharmaceutical Industries and Assciatins (EFPIA) and the French Pharmaceutical Cmpanies Assciatin -Les Entreprises du Médicament (LEEM)-. Patient rganizatins are defined as nt-fr-prfit rganizatins duly registered (including the umbrella rganizatins t which they belng), mainly cmpsed f patients and/r caregivers, that represent and/r supprt the needs f patients and/r caregivers. This cde f practice builds n the fllwing principles that Pierre Fabre Affiliates will always be keen t bserve in its relatins and partnership with patient rganizatins: 1. Independence f patient rganizatins must be guaranteed, in particular with regards t their plicies, activities and plitical judgment. 2. Mutual respect is the basement f partnerships, with the views and decisins f each partner having equal value. 3. Nn-cmmercial bjectives: the prmtin f a Pierre Fabre s drug shall never be the reasn r purpse f the partnership. 4. Transparency: the bjectives, the scpe f partnership, financial and nn-financial supprt prvided by Pierre Fabre Affiliates shall always be clearly acknwledged. 5. Nn-exclusive relatinships: Pierre Fabre Affiliates will never require t be the sle funder f a patient rganizatin r any f its majr prgrammes. APPLICABILITY This cde f practice must apply in a manner cmpatible with natinal laws and regulatins t which Pierre Fabre Affiliates may be subject and/r with applicable pharmaceutical industry cdes dealing with relatinships between pharmaceutical industry and patient rganizatins cuntries in which the activities 1 Cde f Ethics - Pierre Fabre Labratries (2015) 2 Pierre Fabre Médicament & santé: Prmtin f Drugs & Relatinships in the Healthcare Sectr - Cde f Best Practices (January 2015)

3 3 take place. In the event f a cnflict between the prvisins f this cde and any ther applicable cdes r laws referred t abve, the mre restrictive f the cnflicting prvisins shall apply, as much as they d nt vilate any law in frce. The cde that applies is t be specified in the written agreement between Pierre Fabre Affiliates and patient rganizatins. Principles and rules describes belw apply t all relatinships between Pierre Fabre Affiliates and patient rganizatins and must be respected by any Pierre Fabre Affiliates emplyee dealing in this cntext. PROVISIONS ARTICLE 1 Nn-prmtin f medicines Prmtin f Pierre Fabre s drug must never be cnsidered within the cntext f relatinships between Pierre Fabre Affiliates and patient rganizatins partnerships. ARTICLE 2 Nature f Services Pierre Fabre Affiliates may subcntract t patient rganizatins different types f services nly if such services are aimed at supprting healthcare r research and nly if such services are authrized as per the crprate charters f bth the patient rganizatins and the Pierre Fabre affiliate. Pierre Fabre Affiliates may als engage patient rganizatins as experts r advisrs such as attendance t advisry bard meetings and speaker s services. The arrangements that cver cnsultancy r ther services must, t the extent relevant t the particular arrangement, fulfil all the fllwing criteria: a. A written agreement is signed in advance (see Article 3); b. A legitimate need fr the services has been clearly identified and dcumented prir t requesting the services and entering int the arrangements; c. The criteria fr selecting services are directly related t the identified need and the persns respnsible fr selecting the services have the expertise necessary t evaluate whether the particular experts and advisrs meet thse criteria; d. The extent f the service is nt greater than is reasnably necessary t achieve the identified need; e. Pierre Fabre Affiliates maintain recrds cncerning, and make apprpriate use f, the services; f. The engaging f patient rganizatins is nt an inducement t recmmend a particular medicinal prduct;

4 4 g. The cmpensatin fr the services is reasnable and des nt exceed the fair market value f the services prvided. In this regard, tken cnsultancy arrangements must nt be used t justify cmpensating patient rganizatins. ARTICLE 3 Written agreement All services subcntracted, partnerships, funding, indirect r nn-financial supprt t patient rganizatins must be set ut in a written agreement. The agreement must specify: the purpse f the partnership, funding r supprt and a clear descriptin f the nature f the invlvement f the parties; the nature f services subcntracted and the basis fr payment f thse services; a descriptin f the assistance r indirect supprt and f nn-financial supprt; the amunt f funding, payments etc.. ; whether the Pierre Fabre affiliate wish t use the lg f the rganizatin r equipment bearing the rganizatin's name r lg. In that case, the terms f use must be specified; infrmatin cncerning the publicatin f transfers f value between the Pierre Fabre affiliate and the rganizatin shuld be included accrding t applicable regulatins and legislatin, in terms f the transparency f relatinships and persnal data prtectin. a prvisin regarding an bligatin f patient rganizatins t declare, whenever they write r speak in public abut a matter that is the subject f the agreement r any ther issue relating t Pierre Fabre Affiliates, that they have prvided paid services t Pierre Fabre Affiliates, r received funding r indirect r nn-financial supprt frm Pierre Fabre Affiliates. the reference t the prfessinal/natinal cde(s) f ethics that is (are) in frce in this agreement. All parties shuld be fully aware that spnsrship must be clearly acknwledged and apparent frm the utset. ARTICLE 4 Editrial cntrl Pierre Fabre Affiliates must nt seek t influence r select the text n the rganizatin s material r equipment in rder t favr its wn interest. Crrectin fr factual errrs may still be prpsed. The purpse f the partnership must nt be t prmte the Pierre Fabre s drugs, and natinal and internatinal laws in frce prhibiting the advertising f prescriptin drugs t the general public apply.

5 5 ARTICLE 5 Transparency Accrding t legislatin and natinal assciatin s cdes that are lcally applicable, Pierre Fabre Affiliates must be able, as much as this des nt vilate any law in frce, t: prvide a list f patient rganizatins t which it prvides direct r indirect financial r nnfinancial supprt, including a brief descriptin f the nature f this supprt recrd and trace all financial relatinships r transfers f value frm the cmpany t patient rganizatins (csts fr accmmdatin, meals, travel, registratin fees, established fees, including fr R&D activity agreements, etc.), with the aim f ptential disclsure, in accrdance with applicable lcal regulatins r prfessinal assciatin cdes. ARTICLE 6 Events All events spnsred r rganized by r n behalf f Pierre Fabre Affiliates (including cngresses, cnventin bth rental, prfessinal r scientific meetings, bards f experts, prductin r research site turs, investigatr meetings, spnsring assciatins r learned scieties fr the rganizatin f these events, etc.) must aim t cntribute t the bdy f scientific r educatinal infrmatin fr patients rganizatins. They must be held in "apprpriate" venues that crrespnd t the purpses f the event. Pierre Fabre Affiliates must nt rganize r fund events in places that are renwned fr their entertainment facilities r are extravagant. N event may be rganized r spnsred utside the cuntry f rigin f the patient rganizatins invlved, unless this is relevant and justified frm a lgistical r security pint f view 3. Events welcming participants frm several cuntries are allwed. The chice t participate, t spnsr an event r finance the participatin f a patient rganizatin in an event must cmply with the fllwing criteria: Gegraphical lcatin Depending n the facilities and accmmdatins available and ptentially the safety cnditins: fr example, the chice f a city r a lcatin near a city knwn fr its science infrastructures and its business center, as well as easy access fr the varius participants, and nt fr its turism and leisure 3 e.g. if a significant number f attendees cme frm cuntries ther than that f the patient rganizatin r the Pierre Fabre affiliate, r if the place where relevant expertise fr the event is lcated utside the patient rganizatin r the Pierre Fabre affiliate s cuntry f residence and it makes greater lgistical sense t hld the event in anther cuntry.

6 6 infrastructures. The lcatin must nt be cnsidered as the main attractin, r implied r perceived as such. The event date must nt cincide with the date f a cultural r sprting event in the same place, r take place just befre r just after such an event. Capitals and majr cities cnsidered as business and ecnmic hubs are apprpriate fr the rganizatin f such events. A particular lcatin that is nt in accrdance with the abve rules can nly be selected when the aim f the meeting, the scientific r medical prgram and the availability f the necessary and apprpriate expertise warrants this. Venue: It must be in line with the scientific r medical bjective f the event, and prvide the technical infrastructure fr hlding meetings, cnferences and exhibitins, and nt cultural, sprts and leisure infrastructures. If pssible, it shuld be lcated away frm well-knwn turist spts. The fllwing shuld be avided: glf curses, spas, beach, lake r riverside resrts, ski resrts, casins, etc. (nn-exhaustive list). The safety f participants must be guaranteed. Scientific r medical prgram: This prgram must be available in advance t allw participants t chse t participate r t spnsr the event, r nt, accrding t its presumed scientific and educatinal quality. It must nt include free time fr entertainment t be rganized, between scientific/medical sessins. It must be adapted t the scientific/medical bjective f the event: scientific and educatinal value, nature and quality f the speakers, participants, etc. Meals must nt be rganized in cnnectin with cultural r leisure events. T ensure cmpliance with laws in all relevant jurisdictins, which vary frm ne cuntry t anther, the prgram must refer t the cdes f relevant natinal assciatins 4 when rganizing internatinal events. All Pierre Fabre partners likely t make recmmendatins at lcal level must be infrmed f these cdes. ARTICLE 7 Hspitality As part f rganized r spnsred events, hspitality may be ffered t participating patient rganizatin s members. Only csts related t travel, meals, accmmdatin and registratin fees may be cvered. They must be reasnable in level and must be limited t the main purpse f the event, whether the event is rganized 4 e.g. such as the EFPIA Cde f Practice n Relatinships between the pharmaceutical industry and patients rganizatins in the EU ( r the LEEM Dispsitins déntlgiques prfessinnelles (

7 7 by the Pierre Fabre affiliate r the patient rganizatin. Generally, csts incurred must nt exceed what the participants wuld themselves be willing t spend fr an event f this type. The amunts fr meals must nt exceed the maximum defined by lcal laws/regulatins where apprpriate. The csts cvered must nt be extended t participants cmpanins if they are nt qualified t fully participate in the event. Hspitality may nly be extended t persns wh qualify as participants in their wn right. In exceptinal cases, in case f clear health needs (e.g. disability), the travel meals, accmmdatin and registratin fees cst f an accmpanying persn cnsidered t be a carer can be taken. N entertainment, recreatinal r scial activities r ther events f a festive nature may be cvered r spnsred. Accrding t lcal regulatins, a prtin f the csts f the event will remain the respnsibility f the patient rganizatins and their representatives. The duratin f this hspitality must be strictly limited t that f the event.