The Fifth International PHARMACEUTICAL COMPLIANCE CONGRESS and BEST PRACTICES FORUM Istanbul, 4 May 2011 EFPIA Leadership Statement: One Year s Experience Marie-Claire PICKAERT Deputy Director General 1
EFPIA The aim of the European Federation of Pharmaceutical Industries & Associations, which has no profit-making purpose, is to promote pharmaceutical discovery and development in Europe and to bring to the market medicinal products in order to improve human health worldwide. EFPIA pursues a mainly scientific aim, ensuring and promoting the technological and economic development of the pharmaceutical industry in Europe. EFPIA s represents the pharmaceutical industry operating in Europe. Its direct membership includes 31 national associations and 40 leading companies. Two specialised groups within EFPIA represent vaccine manufacturers EVM, with 9 member companies) and emerging biopharmaceutical companies EBE with 65 member companies. 2
EFPIA Ethics Issues Codes Committee Compliance Committee National Ethics Groups Implementation & enforcement of Codes = CODES AUTHORITY (member associations & National codes authorities) Role & mandate defined under the EFPIA HCP & PO Codes provisions Codes Steering Group Developing additional guidance in line with the Leadership Statement, promotion of good practice and prevention of inappropriate behaviour (including monitoring) Member associations + Corporate Compliance Officers Ensuring effective oversight of industry standards, and implementation of the new guidance Set up at national level by local operations 3
Legislation & Self-Regulation Legislation EU Directive 2001/20 GOOD CLINICAL PRACTICE (GCP) in the context of clinical trials (applicable since 2004) EU Directive 2001/83 in particular, the section on INFORMATION & ADVERTISING (first adopted in 1992), included in EU Pharmaceutical Legislation National regulation implementing EU provisions; national legislation may be more restrictive / prescriptive EFPIA Self-regulation EFPIA Healthcare Professionals (HCP) / Patient Organisations (PO) Codes national codes may be more restrictive; in some areas, EFPIA Codes require specific action from membership (latest reviewed in 2007) Joint Declaration of CPME and EFPIA on the Cooperation Between the Medical Profession and the Pharmaceutical Industry (June 2005) Leadership Statement of 21 June 2010 National self-regulation implementation and enforcement of EFPIA s Codes provisions; national self-regulation may be more restrictive / prescriptive 4
Trust and Perception The common goal of rules adopted is to embrace responsibility for the company s action through ethical behaviour taking into account the interest of those on whom company s activities (may) have an impact = CORPORATE SOCIAL RESPONSIBILITY Self-regulation mechanisms monitor and ensure business active compliance with the spirit of the law, ethical standards, and international norms. Ethical compliance is (pro)actively promoted by voluntarily eliminating practices that (may) harm the public interest, regardless of legality = DO s and DON Ts As science becomes more innovative and medical research processes more creative, the ethical boundaries that limited what was considered possible are now being challenged by scientific endeavour using rational justifications that often go beyond common sense. 5
LEADERSHIP STATEMENT June 2010 6
Leadership Statement General statements of industry leaders Full respect for the role that EU legislation plays in regulating interactions between pharmaceutical companies and healthcare professionals Commitment to working towards greater transparency, accountability and ethical behaviour within an industry framework of self-regulation Adherence to EFPIA Codes establishing standards for appropriate behaviour in companies relations with healthcare professionals and patient organisations is essential breaches should not be tolerated Establishment of National Ethics Groups in EFPIA s member associations Inviting non-member companies to adhere to self-regulatory rules and guidance adopted by the R&D-based pharmaceutical industry Developing additional guidance around 5 areas to ensure that EFPIA membership continues to uphold the highest standards 7
Vision Board s expectation is that EFPIA delivers on the LS with a vision of: Øchanging attitudes Østrengthening compliance Øbeing responsive to a world that moved to a different place Therefore, additional guidance should: Øinclude monitoring / enforcement mechanisms Øevolve towards more rigorous and effective standards Øin a manner consistent with competition and other legal obligations 8
Areas for Additional Guidance EFPIA was asked to develop additional guidance around the following areas: 1.Provision Legislative of information process 2.Medical sales representatives Additional EFPIA 3.Medical samples: 4x2 standard guidance HCP Code Revision to be issued 4.Congresses and other meetings, including exhibitions at congresses 5.Relationships with patient organisations EFPIA PO Code Revision e4ethics 9
Provision of Information BACKGROUND EC proposals (Directive and Regulation) on "information to the general public on prescription medicines" left-over the 2001 review of the EU pharmaceutical legislations 2001 (most controversial part of the Pharma Package launched in 2008) Massive campaign against the Commission proposals trust and reputation of pharmaceutical companies was at the heart of stated objections Member States (represented in the Council) decided to freeze their debate on the proposals in June 2009 After a lengthy debate (with 500 amendments), the (new) European Parliament concluded its first reading in November 2010 with an overwhelming majority The (New) Health Commissioner John DALLI has taken a generally supportive attitude towards improved access to information by the public at large, and will present his "modified proposals (announced) in May 2011 Pressured by Parliament, Council of Ministers is requested to resume its debate Hungarian EU Presidency made this a priority Øpolitical orientation expected from Health Council 6/7 June 2011 10
European Parliament Opinion Final reports adopted by 90% majority EP criticises current disparities across the EU in accessing high-quality, non-promotional medicines information in local language EP emphasizes patients right to information and calls on improving access to quality information while keeping the ban on advertising EP recognises the complementary role of marketing authorisation holders (MAH) in providing non-promotional information on their products to patients, based on agreed quality criteria and clear rules for (pre-)approval and monitoring of information Information from the MAH should only be made available through the following channels: registered internet websites (excluding unsolicited material) answers [in writing and orally] to specific requests for information printed materials about a medicinal product prepared by the MAH upon specific request by a member of the general public 11
Medical Sales Reps Objective: Building on existing legal obligations and industry standards, developing guidance for defining standards and housekeeping rules for medical sales representatives Deliverables: Defining scope, which may need to take into consideration the evolution in the role of sales representatives and technology; also addressing functions under different departments Identifying areas to be covered by housekeeping rules, including areas that raise reputational issues in practice guidance should be conducive to medical education, and provide adequate support to doctors in their continued medical development Developing standards that are effective and practical; enhancing training Reflecting on monitoring mechanisms At this stage, no further additional guidance is expected. However, current debates in several EU countries about the role of med reps may trigger further discussion. 12
Medical Samples Objective: Supporting (self-)regulation moves towards the 4 X 2 standard i.e. Each healthcare professional should receive, per year, no more than 4 samples of a particular medicine he / she is qualified to prescribe; and sampling should not extend beyond the two years after the product is first launched Deliverables: Restating the limitation to sampling under the EU Directive Clarifying conditions under which samples can be given to healthcare professionals Preventing sampling taking place outside the strict exceptional cases allowed under EU legislation Providing clear guidance to the member associations in evolving towards the 4 x 2 standard 13
Revision of the HCP Code With a view of breaking the deadlock at national level where it was not clear who should move first, member associations waiting for a signal from companies, and vice versa the Board / Executive Committee agreed to include additional guidance on medical samples in the EFPIA HCP Code. Answering remaining anti-trust concerns, Davis Polk & Wardwell has summarised its analysis in a Memorandum on the EFPIA HCP Code amendment on medical samples. It concludes that the proposed change to the EFPIA HCP Code is neither anticompetitive in purpose and object, neither in its effect. The EU Directive reflects the legislative judgement that medical sampling can improperly influence and distort prescribing decisions by HCPs. Therefore, the EFPIA HCP Code amendment represents a commitment by the EFPIA membership to behave in a manner consistent with EU public policy. It should be noted that, in part due to absence of comparable legislative action, the above analysis is limited to Europe and does not extend to the US. 14
Amended Section 16.01 1/3 proposal to be approved at June 2011 SGA In accordance with the EU Directive 2001/83/CE, in principle, no medical samples should be given, except on an exceptional basis. Medical samples must not be given as an inducement to recommend, prescribe, purchase, supply, sell or administer specific medicinal products, and should not be given for the sole purpose of treating patients. Medical samples are provided to HCP so that they may familiarise themselves with the medicines and acquire experience in dealing with them. In accordance with national and/or EU laws and regulations, a limited number of medical samples may be supplied on an exceptional basis and for a limited period. A reasonable interpretation of this provision is that each HCP should receive, per year, not more than 4 medical samples of a particular medicine he/she is qualified to prescribe; and medical sampling should not extend beyond the 2 years after that particular medicine is first launched. In consideration that the launch date may be different from the date of availability for prescription under national healthcare conditions, the launch date applying to this provision is defined by each pharmaceutical company. 15
Amended Section 16.01 2/3 proposal to be approved at June 2011 SGA In this context, a new medicine is a product for which a new MA has been delivered either following an initial MA application or following an application for a new strength / dosage form that includes a new indication (warranted by a separate MA). Extensions of the MA to additional strengths / dosage forms (for existing indications) or pack sizes (number of units in the pack) cannot be considered as new medicines. Without prejudice to the ban on medical sampling of medicines containing psychotropic and narcotic substances, medical samples can only be given in response to a written request from HCP qualified to prescribe that particular medicine. Member Associations are also encouraged to provide additional guidance on the meaning of the phrases first launch and new medicine. On an exceptional basis, Member Associations may allow, through additional guidance, a longer period than 2 years if required by local healthcare conditions. 16
Amended Section 16.01 3/3 proposal to be approved at June 2011 SGA Implementation Corporate members are asked to put in place to relevant monitoring and control tools, including internal control and / or external audit procedures. Member Associations will be required to implement the proposed revisions to sections 16.01 (new text) and 16.06 (deletion) of the EFPIA HCP Code, no later than 31 December 2011. Member Associations are also asked to support legislative or regulatory change to the same effect. EFPIA will ask the membership to report on progress. 17
Events & congresses Objective: Developing common standards for meetings organised / sponsored by industry and attended by healthcare professionals Deliverables: Reviewing the standards applicable, and clarifying scope Reviewing implementation required by the EFPIA HCP Code (defining reasonable ; providing guidance on appropriate ; renowned ; and extravagant venues) identifying room for common guidance and improved consistency Addressing overshadowing exhibitions and reducing the arms race 18
Events Pre-Assessment Objective: Setting up an on-line platform to pre-assess events in regard of the EFPIA HCP Code Deliverables: Criteria for the pre-assessment of events Setting up a process for the promotion of compliance with industry highest standards, the prevention of inappropriate behaviour Sponsoring corrective actions through leveraging corporate compliance officers role EFPIA s new website e4ehtics will host the database of pre-assessment reports re Article 9 of the EFPIA HCP Code. Corporate members are encouraged to consult the database before making their own individual decisions to sponsor, participate or collaborate in the event. It is also recommended to check the rules prevailing under applicable national codes. Ø José Zamarriego will provide details 19
Research & Medical Education Objective Enhancing research & medical education at congresses Creating insight and understanding of the major undertakings involved in developing new medicines Enhancing the reputation of industry as a scientific partner Deliverables -Creating an (other) area for interaction with HCPs, besides the traditional exhibition area, which would be strictly devoted to scientific communication between R&D representatives and delegates at the congress -Engaging with scientific & medical societies and congress organisers to allocate space for a Research & Medical Education Campus (R&ME Campus) at congresses, and agree strict requirements applicable in this reserved area -Engaging with accreditation bodies endorsing CME programmes 20
Requirements re R & ME Campus Scientific exhibits Creating an appropriate environment for communication and interaction about ongoing research initiatives, allowing for scientific exchange in a low pressure environment Requirements -The R & ME Campus (scientific area) should be clearly differentiated from the company s commercial area, using visible means to distinguish both areas -Information provided at the R & ME Campus should focus on research, and not contain any product branding or trademarks -The area should be manned by senior scientific and medical staff from the company s R&D function; no sales or marketing staff should access this area -Gifts and promotional items are totally banned from the R & ME Campus -Any printed materials and all communication on the R & ME Campus should have a strong research focus and be strictly limited to scientific reprints and general information about the research conducted 21
Next steps IPCAA s Cardiology Working Group has initiated discussions with the European Society of Cardiology (ESC) and the European Board fro Accreditation in Cardiology (EBAC). IPCAA s Working Group asked for EFPIA support, and requested that EFPIA issues guidelines on the requirements for the management of R & ME Campus areas at scientific congresses. Collaboration has started, building on IPCAA s work. ØCollaboration between EFPIA and IPCAA has started 22
Outreach to Congress Organisers Objective: Exerting peer review pressure through site visits at congresses Deliverables: Reporting on visits of selected congresses in Europe organisers and scientific societies advised of EFPIA s plan to visit Improving understanding of industry s rules applying to their relations with healthcare professionals Sharing findings with the Compliance Committee and prevent inappropriate behaviour, including reducing the arms race at exhibitions Looking for pragmatic solutions to issues arising with congress organisers and scientific societies Programme of site visits to yearly congresses of major Scientific & Medical Societies will be repeated in 2011. 23
Review of EFPIA s PO Code Mandatory disclosure of support to patient organisations Objective: Requiring companies to disclose the amount of support provided to patient organisations this mandatory requirement needs a review of the EFPIA PO Code Deliverables: Defining the total amount of support provided, which should include: (i) the amount of financial support; (ii) the amount of cost invoiced to the sponsoring company for significant non-financial support; (iii) for significant indirect support not covered by invoices and for significant non-financial support, the company will provide its best estimate established in good faith of costs incurred Providing guidance as to the format in which the total amount of support should be disclosed Identifying legal and practical issues arising (also from PO s point of view) 24
Implementation of the LS Call for action As an additional step towards increased transparency, we, leaders of the industry, have instructed EFPIA to review its PO Code with a view to requiring mandatory disclosure of financial and significant indirect / non-financial support to patient organisations. Revision of the EFPIA PO Code Each company must make publicly available a list of patient organisations to which it provides financial support and/or significant indirect/non-financial support. This should include a description of the nature of the support that is sufficiently complete to enable the average reader to form an understanding of the significance of the support. The description must include the monetary value of financial support and of invoiced costs. For significant non-financial support that cannot be assigned a meaningful monetary value the description must describe clearly the non-monetary benefit that the patient organisation receives. 25
Contracted Services Covers provision of services to companies by patient groups (e.g. participation in ad boards, speaker services) Written contract/ agreement required, records maintained Compensation of services according to fair market value Disclosure elements 26
Conclusions Leadership Statement: One Year s Experience Debate has helped clarifying actions required by the leaders of industry Hesitation / reluctance has turned into willingness / preparedness to get it right After formal approval of HCP / PO Codes revisions by the General Assembly in June, EFPIA will have delivered on actions required next step: ensuring implementation and enforcement More to come: CSR Tajani Initiative Relationships with physicians Steered by Industry & CPME Ø Building on the EFPIA HCP Code disclosure of support to HCPs Relationships with patients Steered by Industry & EPF Ø Put on hold until clarity about the revision of the Information and Advertising Directive, in particular the Information to Patients section Relationships with government officials Steered by Commission & Member States Ø New ground to be covered building on rules applicable 27
Developing common standards for meetings organised / sponsored by industry and attended by HCP For reference 28
Directive 2001/83/CE Article 94 1. Where medicinal products are being promoted to persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of medicine or pharmacy. 2. Hospitality at sales promotion events shall always be strictly limited to their main purpose and must not be extended to persons other than HCP. 3. Persons qualified to prescribe or supply medicinal products shall not solicit or accept any inducement prohibited under 1 or contrary to 2. 4. Existing measures or trade practices in Member States relating to prices, margins and discounts shall not be affected by 1, 2 and 3. Article 95 The provisions of Article 94(1) shall not prevent hospitality being offered, directly or indirectly, at events for purely professional and scientific purposes; such hospitality shall always be strictly limited to the main scientific objective of the event; it must not be extended to persons other than HCP. 29
EFPIA HCP CODE Article 9 Events & Hospitality 1. All promotional, scientific or professional meetings, congresses, conferences, symposia, and other similar meetings,... Organised or sponsored by or on behalf of a company must be held in an appropriate venue that is conducive to the main purpose of the event and may only offer hospitality when such hospitality is appropriate and otherwise complies with the provisions of any Applicable Code(s). 2. No company may organise or sponsor an event that takes place outside its home country unless: a) Most of the invitees are from outside of its home country and, given the countries of origin of most of the invitees, it makes greater logistical sense to hold the event in another country; or b) Given the location of the relevant resource or expertise that is the object or subject matter of the event, it make greater logistical sense to hold the event in another country (an international event ). 30
EFPIA HCP CODE 3. Promotion information which appears on exhibition stands or is distributed to participants at international events may, unless prohibited or otherwise regulated by local laws and regulations, refer to medicinal products (or uses) which are not registered in the country where the event takes place, or which are registered under different conditions, so long as: i. Any such promotional materials (excluding promotional aids) is accompanied by a suitable statement indicating the countries in which the product is registered and makes clear that the product or use is not registered locally; and ii. Any such promotional material which refers to the prescribing information (indications, warnings, etc.) authorised in a country or countries where the medicinal product is registered should be accompanied by an explanatory statement indicating that registration conditions differ internationally. 4. Hospitality extended in connection with events shall be limited to travel, meals, accommodation and genuine registration fees. 5. Hospitality may only be extended to persons who quality as participants in their own right. 31
EFPIA HCP CODE 6. All forms of hospitality offered to HCP shall be reasonable in level and strictly limited to the main purpose of the event. As a general rule, the hospitality provided must not exceed what healthcare professional recipients would normally be prepared to pay for themselves. 7. Hospitality shall not include sponsoring or organising entertainment (e.g., sporting or leisure) events. Companies should avoid using venues that are renowned for their entertainment facilities or are extravagant. 8. Member Associations shall provide guidance on the meaning of the terms reasonable, as used in this Article 9. Member Associations shall also provide guidance on appropriate, renowned and extravagant venues, as used in Section 9.01 and Section 9.07. Companies must comply with any relevant guidance provided under this Section 9.08 in connection with any Applicable Code(s). 32
CPME EFPIA Joint Declaration MEETINGS ORGANISED OR SPONSORED BY INDUSTRY 9. Pharmaceutical companies may arrange or sponsor meetings for doctors. Such events must have a clear educational content. The information rendered at any meeting should be based on scientific and medically relevant data. 10. Activities, which form part of systematic continuing professional development (CDP) should be reviewed and certified by relevant bodies. 11. In the announcement the purpose of the event should be clearly stated. Where appropriate, it will also be indicated whether the event is reviewed and certified. 12. The venue of the meeting should be appropriate for the scientific purpose of the meeting, and should not involve travelling beyond what is needed. 33
CPME EFPIA Joint Declaration 13. Industry may pay for lecturers, study material and facilities that are needed for the meeting. It can also pay for travelling and lodging for participants but not for any accompanying persons. 14. Hospitality during the meetings should be generally acceptable, reasonable and strictly limited to the purpose of the event. Sponsoring or organising of sporting or entertainment events is prohibited. 15. The principles of this declaration shall apply also for activities taking place outside EU, EFTA and EEA countries when EU, EFTA and EEA doctors are involved. 34