Nordic Transparency A Cocktail of Sunshine and EFPIA Rules

Transcription

1 Nordic Transparency A Cocktail of Sunshine and EFPIA Rules Nicolai Ellehuus Head of Legal and Compliance, Nordics, Mundipharma April 2015 CBI:

2 Disclaimer The views expressed during this presentation are those of the presenter and do not represent the views of the network of independent associated companies of Mundipharma/Norpharma/NAPP/Purdue

3 Agenda 1. Overview of legal/compliance role and transparency in Nordics 2. Prioritizing transparency implementation project 3. Local help Industry Associations 4. Practical implementation

4 The Nordic countries Mundipharma AS, Oslo IcePharma, Rejkjavik (distrb) Norpharma A/S, Vedbæk Mundipharma Oy, Vantaa Mundipharma AB, Göteborg

5 My role Head of Legal and Compliance, Nordics Position created in end-2013 Establish legal services Drive compliance framework with help from local compliance officers My week: Monday Tuesday Wednesday Thursday Friday NO: SE: FI: DK: License- HR-law Tender Corporate Law Supplychain contract

6 Nordics and Transparency Overview: 3 countries with EFPIA implementation (,, ) 1 country with no-efpia membership but still adherence to code ( ) 1 country with hard law implementation ( )

7 Nordics and Transparency Finland: Implemented in Local Code Norway: Implemented in Local Code Sweden: Implemented in Local Code Iceland: The EFPIA Disclosure Code will effectively come into force 1. January Althoug Frumtök is not a formal member of EFPIA we acknowledge the Discloslure Code and fully implement it, as we have done with the EFPIA HCP Code. This decision has been approved by Frumtök s board and discussed at Frumtök s members meeting with no objections. Denmark: 1. November 2014 amended law in place

8 Sunshine in Denmark Notification: Speaker agreement Research Ownership up to DKK ( EUR) Permission: Consultancy Positions of Trust Ownership above DKK ( EUR)

9 Agenda 1. Overview of legal/compliance role and transparency in Nordics 2. Prioritizing transparency implementation project 3. Local help Industry Associations 4. Practical implementation

10 Priority of implementation project Everything begins with a legal risk assessment:

11 Priority of implementation project Legal risk assessment turns into an action plan:

12 Priority of implementation project Strategic Project in Legal & Compliance Strategy 2014: 1. Implementation of L&C organisation 2. Due Diligence 3. Contract Templates 4. Systems 5. EFPIA Disclosure Code: 5 countries 5 implementation projects

13 Priority of implementation project Addressed in Compliance Committee meetings in almost all meetings during Q1 Introduction Q2 Training and creation of working group Q3 Training and update on progress from working group Q4 Training and test of new process

14 Agenda 1. Overview of legal/compliance role and transparency in Nordics 2. Prioritizing transparency implementation project 3. Local help Industry Associations 4. Practical implementation

15 Finland and Transparency Local Code: CODE FOR THE DISCLOSURE OF TRANSFERS OF VALUE 124 Information obligation and scope of application. 125 Individual disclosure. 126 Aggregate disclosure. 127 Non-repetition of information. 128 Economic benefits related to research and product development. 129 Publication methods. 130 The publication takes place annually and the reporting period is one full calendar year.

16 Norway and Transparency Local Code: RULES FOR MARKETING OF MEDICINAL PRODUCTS 15. Transparency regarding transfer of value from pharmaceutical companies to healthcare professionals or healthcare organisations Reference to EFPIA's regulations and the scope of application of the rules Annual reporting and form of disclosure National and international reporting Individual and aggregate disclosure

17 Sweden and Transparency Local Code: ETHICAL RULES FOR THE PHARMACEUTICAL INDUSTRY IN SWEDEN Section 3 Disclosure of transfers of value Art. 1 Definitions Art. 2 Scope of duty of report Art. 3 When disclosures shall be made Art. 4 How disclosure shall be made Art. 5 Platform for disclosure Art. 6 Applicable rules Art. 7 Language Art. 8 Documentation and retention of records Art. 9 Individual disclosure Art. 10 Aggregated disclosure Art. 11 Indirect transfers of value to health care personnel Art. 12 Transfers of value for research and development Art. 13 Methods of disclosure

18 Iceland and Transparency Local Code: ETHICAL RULES FOR THE PHARMACEUTICAL INDUSTRY IN SWEDEN Section 3 Disclosure of transfers of value Art. 1 Definitions Art. 2 Scope of duty of report Art. 3 When disclosures shall be made Art. 4 How disclosure shall be made Art. 5 Platform for disclosure Art. 6 Applicable rules Art. 7 Language Art. 8 Documentation and retention of records Art. 9 Individual disclosure Art. 10 Aggregated disclosure Art. 11 Indirect transfers of value to health care personnel Art. 12 Transfers of value for research and development Art. 13 Methods of disclosure

19 Denmark and Transparency

20 Agenda 1. Overview of legal/compliance role and transparency in Nordics 2. Prioritizing transparency implementation project 3. Local help Industry Associations 4. Practical implementation

21 Practical Implementation - Iceland correspondance with distributor, agreeing on their approach.

22 Practical Implementation SE/FI/NO Working Groups established Typical working group members: Local compliance officer, one finance and one brand manager Issues looked into: - Consent: possibility to give consent in contract but also one specific consent-form - Training of sales reps. and other key stakeholders - Discussion of importance of reaching out to HCPs - Preparation for media attention - Ongoing awareness of rules

23 Practical Implementation - Denmark Very late draft of legislation Difficulty preparing organisation for new rules HCPs to perform reporting themselves Pharma companies to inform HCPs about their duty to selfreport Industry Association (LIF) collaboration with DHMA to agree on suitable level of information to HCPs 16th of October 2014 information forwarded from LIF to members. Short implementation time

24 Practical Implementation - Denmark Communication and training to sales reps. and key stakeholders ( s, intranet, face-to-face) Q&A Document for sales reps. to answer HCPs questions Brochure to HCPs, published by industry association (LIF)

25 Contract clause - Denmark When entering into this kind of agreement Norpharma is obliged to inform you about the rules in section 202a and 202c of the Danish Health Act and the rules laid down pursuant to such provisions (i.e. the Executive Order No of 22 October 2014). The said rules requires you to either obtain a prior permission from the Danish Health and Medicines Authority or to notify the Danish Health and Medicines Authority. Please review further guidance about your obligations issued by Sundhedsstyrelsen at Your attention is directed towards the fact that Norpharma, once per year, is required to disclose our collaboration to the Danish Health and Medicines Authority in accordance with the Executive Order No of 22 October 2014.

26 Follow-up 2015 Compliance with rules are going well. Next step: creation of methodology note. Transparency compliance is still a key strategic project in Legal & Compliance Strategy 2015 Continues to be an agenda point in Compliance Committee meetings in all countries

27 Thank You Tack Takk Tak Kiitos Þakka þér fyrir Contact: Nicolai Ellehuus Cell: