Transparency & related issues Some industry considerations

Transcription

1 Transparency & related issues Some industry considerations Aline Lautenberg, Eucomed, EDMA & MedTech Europe 25 March 2014

2 Content Introduction Transparency & related developments Conclusion Back-up slides

3 Eucomed & the MedTech industry There are more than 500,000 medical technologies registered, ranging from syringes and bandages to orthopaedic implants and pacemakers (20,000 generic groups) Source: Global Medical Devices Nomenclature (GMDN) Agency, 2010

4 Transparency a multi-faceted concept Transparency laws/code: Laws and/or ethical codes that require from MedTech & pharma companies to track and report publicly payments made to healthcare professionals. Also referred to as "Sunshine", "aggregated spend", "disclosure obligations". Examples: French & US Sunshine Laws, EFPIA Disclosure Code Transparency principle: Laws and/or ethical codes that require from MedTech & pharma companies prior written notification or approval is made to the hospital administration, the HCP s superior or other locally-designated competent authority (e.g. MDeon in Belgium; CNOM in France) to fully disclose the purpose and scope of the interaction between the company and the HCP Clinical data/trial transparency: Public access to patient data gathered in clinical trials. Transparency of regulatory data by EU agencies: Different EU Regulatory Agencies (EMA, ECHA,EEA...) have confirmed a trend to greater openness to access requests by the public, coupled with more extensive proactive data dissemination. Transparency directive 89/105/EEC: Transparency obligations for authorities in their pricing and reimbursement procedures for pharmaceutical products.

5 Different approaches to transparency

6 Positions on transparency Eucomed White paper on transparency & disclosure Date: 20 Sept Purpose: Transparency, a core principle of the Eucomed code, is crucial to ensuring that cooperation between HCPs & companies are beyond criticism Support to national member associations, providing minimum arrangements for a national framework for disclosures, including the safeguards to be built in. EFPIA Code on disclosure of transfer of value Date: 24 June 2013 Purpose: Ensure that HCP-industry interactions meet the high standards of integrity that patients, governments and other stakeholders expect. 1 st publication date: 1/01/2016

7 Pharmaceutical industry European initiative 7 Level of Disclosure Aggregate Section 4.01 Individual HCO Section 4.02 & Schedule 2 Individual HCP Section 4.02 & Schedule based on 2015 data Research & Development ToV associated with pre-clinical studies; clinical trials in Phase I to Phase IV; investigator-sponsored studies; and observational, interventional and non-interventional studies. Donations & Grants Sponsorships, events & hospitality; Fees for services & consultancy Donations & Grants Sponsorships, events & hospitality: registration fees; travel & accommodation; and associated ToV (such as food, beverage & others exceeding threshold) Fees for service & consultancy Donations & Grants Sponsorships, events & hospitality: registration fees; travel & accommodation; and associated ToV (such as food, beverage & others exceeding threshold) Fees for service & consultancy

8 8 Issues linked to transparency Many countries ended or are restricting support to individual HCP for passive attendance (U.S., Australia, Sweden, Norway, Netherlands). Discussions also in Asia and South America to allow only grants to PCOs, scientific societies, hopitals. Individual companies decided to not support individual HCP s passive attendance (e.g., Covidien, AstraZeneca). Some medical/scientific societies voice their preferred model of unrestricted grants, linked to a reflection on the future of CME has started (e.g., Ireland, Lower Saxony).

9 The Swedish example New stakeholder agreement (entered in force Jan. 2014) Industry organised events only allowed if in relation with company products/business employers authorisation appropriate venue travel & accommodation cannot be paid by industry. Third-party organised conferences no industry support to individual delegates (e.g., fee, travel & accommodation, as from 01/01/2015) grants/donation can only cover actual, documented, reasonable and direct costs Conference financial outcome has to be reported to company within six months following event - if event generates a surplus, a refund shall, be made to the sponsoring companies. Consultancy employer s authorisation agreement = public document (for public HCPs) objective selection criteria for advisory board activities

10 Implications of these developments Individual Healthcare Professionals Hospitals Scientific societies Industry Professional congress organisers Congress centers & convention bureaux

11 Conclusion More active role of regulators E.g., EC studies on corruption in Europe & healthcare corruption, Netherlands, Denmark, Turkey, etc. Industry will need to further regulate itself, i.e., more stringent and detailed rules, to prevent the appearance or reality of undue industry influence on HCPs Learning curve how to deal with transparency requirements & consequences For individual HCPs, but in the future probably also hospitals, societies & PCOs (e.g., unbundling of individual price components in congress registration fee & transparency in revenue streams, granularity of the required data) Expectation for increase use of due diligence, audit requirements, reporting obligations etc More competition between congresses Need for new innovative models/revenue streams and educational strategies More unpredictable congress attendance (i.e., direct sponsorship developments) Sponsor revenue less reliant, given intense cost-pressure on the industry

12 Thank you! Questions: Speaker

13 Back up slides For information Speaker

14 14 What is compliance? Comply with with established guidelines, specifications and/or legislation, in particular anti-bribery legislation.

15 Anti-corruption & anti-bribery rules Source: TI, Jan. 2014

16 Eucomed Code of Ethical Business Practices The code comprises all of the following documents: Eucomed Compliance and Competition Law Guidelines Eucomed Guidelines on Interactions with Healthcare Professionals Eucomed Guidance Document Q&A on the Guidelines on Interactions with Healthcare Professionals Eucomed Code of Ethical Business Practice: Procedural Framework Opinions and advisory interpretations of the Eucomed Compliance Panel Additional guidance Transparency White Paper (i.e. Disclosure Sunshine) Guidance on Third Party Sales and Marketing Intermediary (SMI) Relationships (i.e. distributors) Access to Operating Theater Position Paper Ethical logo compliance certification scheme

17 Conference Vetting System (CVS) The CVS reviews the compliance of third-party educational conferences with the Eucomed Code of Ethical Business Practice (the Code ) to determine the appropriateness for companies which are members of Eucomed and members of the national associations affiliated with Eucomed to sponsor Healthcare Professionals to participate in such conferences. Independent system ( Conference assessments are binding upon the Eucomed members.

18 Types of HCP-industry interactions Companyorganised events o Disease, indication, product training o Live training o Product launch o Sales & promotional meetings o Plant/factory tour Third-party organised conferences and congresses o Active attendance (speaker) o Passive attendance o Other types of indirect financial support (e.g., booth, advertising, grants to PCOs, medical societies and hospitals) Educational support, Research grants, donations o Courses of further education (e.g. masters degree courses); o Fellowships and similar scholarships; o Books and other educational material; o Education of patients. Consulting o Product development o Speaker fees o Medical and advisory boards

19 Transparency requirement (1)

20 Transparency requirement (2)