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International Transparency & Practical Implications On Global HCP Contracting

February 20, 2013

2EU Transparency Practical Implications © Polaris 2013

Outline of Global Transparency

EFPIA

Country Specific Transparency and Effective Dates

Practical Implications

Appendix

Agenda


Recent Trends In Global Transparency Initiatives

Netherlands:-Medicines Act

Slovakia:-Code of Conduct of Pharmaceutical Industry In Slovakia

USA: -PhRMA-PPACA (Sunshine Act)

UK:-ABPI Code-Anti-Bribery Act

Japan:-JPMA

Australia:-Medicines Australia Code of Conduct

France:-France Sunshine Act “Loi Bertrand”

Government Regulation Industry Codes

Croatia:-Code of Conduct Of Research- Based Pharmaceutical Companies

Where Are We Now? •Individual governing industry groups have created transparency requirements•Various member countries began to create their own transparency requirements•Eucomed code promotes companies to remain transparent•EFPIA drafted a transparency code to streamline and centralize requirements•Currently uncoordinated and disjointed but at some point there will be convergence


The Current Regulatory Atmosphere In Europe European Union Directive/ Regulations (Law)

International Federation of Pharmaceutical Manufacturers & Associations Code of Pharmaceutical Practices (“IFPMA”) (Industry)

European Federation Of Pharmaceutical Industries & Association (Code of practice on Relationships between the Pharmaceutical Industry & Patient Organizations) (Industry)

Eucomed Code of Ethical Business Practices (Industry)

No disclosure requirement

No disclosure requirement • Information disclosed annually • Nature of support clear to the

reader• Must make list of Patient Org’s

they provide support (direct/indirect)

Description of disclosure:1. Money value of financial

support2. Invoiced costs3. Description of Non-monetary

benefits that cannot be assigned meaningful monetary value

• Monetary/Support must be reported by end of first quarter of 2013 (activities from Q1 2012)

Encourage transparency and compliance with industry, local and national laws or codes.

No reporting requirement

EU Transparency Practical Implications© Polaris 2013

5

EFPIA Has Drafted A Transparency Code That Would Bind 33 Pharmaceutical Association And 39 Pharmaceutical Companies

EFPIA Responses to Amended Transparency Directive :

European Federation of Pharmaceutical Industries and Associations EFPIA represents:•33 European national pharmaceutical associations•39 pharmaceutical companiesMembership is voluntary

Publish Codes of Conduct and Practice (similar to Pharma)

Industry Efforts Four Key Areas “AIMS”

Access • Speed up regulatory approval and reimbursement process• Remove government controls on medication that is not reimbursed

Innovation • Making Europe attractive for Research • Ensure fair reward for innovation

Mobilization • Deliver modern medicine • Fight damaging cost-containment policies

Security • Need to strengthen integrity and transparency• Raising public awareness


EFPIA Drafted Code On Disclosure of Transfers of Value From Pharmaceutical Companies to HCO And HCPs

The Code Requires All Member States To Create Transparency Codes Applicable To All Member Companies: Premise: HCP should be fairly compensated for the legitimate expertise and services they provide to the industry. Standards: Sets out the minimum standards which EFPIA considers must apply- country codes will apply when they are inconsistent with EFPIA code. Code Requirements: Imposes obligations on EFPIA’s member companies and associations that will provide detailed disclosure of transfers of value to healthcare professionals and organizations from 2015 onward. Member Companies shall be bound by the relevant Member Association’s code in each country in Europe in which they operate (whether directly or through the relevant subsidiary).

Non Members Countries: Who voluntary implement this Code shall require that each of their respective members comply with all of the provisions of the Code


Two Distinct Disclosure Requirements Proposed Transparency Regulations

Aggregate Disclosure: Research and DevelopmentAggregate Disclosure: Member Company must disclose the total amount of Transfers of Value to Recipients relating to the category of research and development.

Individual Disclosure: Member Company shall disclose, on an individual basis per Recipient, the amount of any Transfers allocated to one of the following categoriesTransfers of Value to an individual HCO: Transfers of Value to an individual

HCP:1. Donations and Grants2. Sponsorships and Events (Registration

fees & Travel accommodation)3. Associated Costs (food, beverage and

others)4. Fees for Service and Consultancy5. Market Research

1. Sponsorships and events (Registration fees

2. Travel & accommodation)3. Associated Costs (such as food,

beverage and others) 4. Fees for Service and Consultancy5. Market Research


Enforcement

Enforcement: Each Member Association code shall impose sanctions for violations.

Sanctions should be proportionate to the nature of the infringement, have a deterrent effect. A combination of publication and fines will generally be considered to be the most effective sanctionThe EFPIA Codes Committee shall produce (at least annually) reports summarising the transposition by Member Associations (for the first time by 31 March 2014) and implementation by Member Companies (for the first time by 31 March 2015).


O-US: The Four Countries That Receive The Most Attention For Their Transparency Initiatives

France UK Netherlands Japan

Requirement Name

Relatif a la modernisation du systeme des produits de sante

ABPI Code of Practice for the Pharmaceutical Industry

Code of Conduct for the Disclosure of Financial Relations

JPMA Transparency Guideline

Requirement Type

Law Industry Guidance Industry Guidance Industry Guidance

Requirement Status

6 Months post Decree publication

Existing• Collection 2012• Reporting 2013

Q1 of 2013 Existing• Collection 2012• Reporting 2013

Reportable Recipients

• HCPs, HCOs, Patient Associations, Students, Scientific Societies, Specialized Media

• HCPs (consultants), HCOs (if payment made to HCO on consultant’s behalf)

• HCPs • HCOs• Associations• Partnerships

• HCPs, HCOs, Medical Schools, Academic Societies

Reportable Payment Types

• HCP, HCO, Associations, Hospitals [public/private], Foundations, Societies, & Consulting companies, Publishing companies, Editors of prescription and dispensing software, Legal entities contributing to initial training of HCPs

• Honoraria; market research (if HCP’s identity is known to company); travel and accommodation

• Consultancy services, Advisory board services, Speaker services, Services for non-interventional research outside the scope of the Dutch law on medical research in humans, Sponsorships

• R&D expenses; academic research grants; honoraria; payments related to provision of information; other (hospitality, etc)

Exclusions • Normal working relationships • Pmt consultants for R&D, clinical trials

• VAT and expenses • None articulated

Reporting Threshold

• €60 • €15

• None (aggregate for all consultant payments during calendar year)

• Entity/Individual who receives €500 (in money or in kind) from a pharmaceutical company annually.

• None (aggregate)


10

The Serious Fraud Office Issues New Policies on Self Reporting, And Will Be A Chief Investigator For Questionable Spend

Serious Fraud Office (SFO): An independent Government department that investigates and prosecutes serious or complex fraud, and corruption. (similar to the OIG in the US)

• Reducing fraud and corruption and the cost of fraud and corruption• Delivering justice and the rule of law• Maintaining confidence in the UK's business and financial institutions

• Taking on appropriate cases• Investigating them and bringing them to successful conclusions as quickly as

individual circumstances allow• Prosecuting fairly and in a way that helps juries understand the issues

• External agencies and organizations• Overseas jurisdictions• Counsel


Practical Implications For Spend Capture And Automation

Internal Controls Required: Vague definitions of spend types to be disclosed require extensive capture

Baseline inventory to establish engagement/ transfers of value the business is currently tracking/reporting

Implications To Consider: Difficult to establish a Fair Market Value for each service/engagement so rates must be adequately documented and backed up with sufficient explanationImplications for global master:•Definitions of Reportable Recipients are different from Federal and State Sunshine (France - Medical Students) •HCP spending is not categorized like it is for sunshine, which it makes it difficult to parse out and categorize (grants, IIT, payments, sponsorship) •Essentially, any benefit or benefit in kind needs to be tracked Multiple vendors - scrubbing, enhancing details

Different attributes - NPI and specialty versus RPPS and degree


Practical Solutions For Regional Spend

Cross-Regional Spend Collection: Establish Guidelines (are you solving Transparency or HCP Spend Automation?)Establish Baseline Collection RequirementsAssessment in Each Region / Global GroupPrepare Deployment StrategyGet To Work (Systems, Change Management, Training, Etc.)


Appendix

EFPIA Response Paper:http://www.efpia.eu/sites/www.efpia.eu/files/FINAL%20Position%20Paper%20 Transparency%20Directive%20%282%29%2029%20May%202012_0.pdf

Commission proposal for a Directive of the European Parliament-- (COM (2012)0084

ABPI Memorandum Of Understanding http://www.abpi.org.uk/our- work/news/2011/Documents/Memorandum%20of%20Understanding%20betw een%20the%20ABPI,%20PMCPA%20and%20SFO%20Final%20April%2020 11.pdf

http://www.efpia.eu/sites/www.efpia.eu/files/FINAL Position Paper Transparency Directive (2) 29 May 2012_0.pdf




http://www.abpi.org.uk/our-work/news/2011/Documents/Memorandum of Understanding between the ABPI, PMCPA and SFO Final April 2011.pdf





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Proposed French Transparency Has €10 Threshold Which Must Be Reported Every Six Months

HCP/HCO

Agreements

(conventions)

Other

Payments

(in kind/cash)

Type of

Covered

Recipients

Reportable Data (January 1st and half‐year update)

Template

Reporting &

Disclosure on

Company Website

Speaker

consulting

Advisory

Boards

Grants

Clinical Trials

Hospitality

Meals

Promotional

Items

HCPs

• Name, Address• Type of customer• Degree, specialty or title ID (RPPS)• Date, form, nature, purpose of payment +

€ amount• Signature date, agreement purpose,

program

Students

• Name, Address• Year and type of studies• University Affiliation• Date, form, nature, purpose of payment +

€ amount• Signature Date, agreement purpose,

program

Organizations

• Name, Legal name and HQ address• Date form, nature, purpose of payment +

€ amount• Signature date, agreement purpose,

program

Phys. paymentsPhys. payments

Phys. agreementsPhys. agreements

Nurse paymentsNurse payments

Nurse agreementsNurse agreements

Midwife paymentsMidwife payments

Midwife agreementsMidwife agreements

Pharma. paymentsPharma. payments

Phar. agreementsPhar. agreements

Dentist paymentsDentist payments

Dentist agreementsDentist agreements

Proposal as of 10/25/12


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French Transparency1 aka The French Sunshine Act Or The Bertrand Law

1Article 2 of the Drug Reform Law, 12/29/2011. Effective Date: Applicable to benefits given and fees paid as of January 1st 2012.


16

The Association Of British Pharmaceutical Industry (ABPI)


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ABPI 1 --- Disclosure Of Payments And Time Of Disclosure Disclosure of Payments UK Overseas 2012 2013 2014

Consultant fees (fees paid to consultants in the UK or to their employers on their behalf). Does not include payments for R&D [Reporting on 3b trials and up. ]

Collect Disclose Disclose

Consultant expenses – accommodation costs


Consultant expenses – travel costs No Collect Disclose Disclose

Market research fees (when identity of participants known)

Collect Disclose

Sponsorship – Registration fees Collect Disclose Disclose

Sponsorship – Accommodation costs Collect Disclose Disclose

Sponsorship – Travel Costs No Collect Disclose Disclose

Grants & donations to UK HCPs (amount & name of recipient, institution, organizations or association)


Support of patient organizations (financial & non-financial, with name of recipient institution, organization or association)

N/A Collect 2011 &

Disclose

Disclose Disclose

1 Association of the British Pharmaceutical Industry


The Netherlands – Medicines Act 1

Inquiry Detail

April 2013 • Financial relationship from 2012 must be entered in the central transparency register

• Reporting Structure:1. Name of HCP/ Partnership/Institution2. Name of pharmaceutical company3. Nature of financial relationship 4. Amount5. Year of relationship

Nature of Relationship

• Consulting service• Advisory Board• Speaker• Non – Interventional Research• Sponsorships

Method of Delivery

• Automated form from the registration.• Unique identifiers will be used for doctors (similar to NPI)• Registration numbers from the Chambers of Commerce will be

used for partnerships and Institutions

1Stichting Code Geneesmiddelen Reclame Newsletter


The Netherland Register Will Be Entrusted In A New Independent Foundation

Transparency Register Transparency register will be set up by the (GCR)1 in collaboration with:

• Ministry of Health• Welfare & Support• Royal Dutch Medical Association (KNMG)• Association for Innovative Medicines in the Netherlands (Nefarma)• Association for Generic Drugs Industry in the Netherlands (BOGIN)

Independent foundation will manage registry

• Register available to public through internet• Data searchable by recipient name • Summary of the reported financial relationships by name

1 Foundation for the Code for Pharmaceutical Advertising


ACCC1 For Authorisation Requires Australia Member Companies To Report Spend In Aggregate Amounts Annually

Requirements For Reporting:

Reportable Information (Updated June 5, 2012)

• Payments made to HCP for advisory and consulting arrangements

• Sponsorships of HCP to attend medical conferences and CME

• Payments to speakers at educational events • Sponsorships of all individual consumer organisations for

each financial year, including the value of non-monetary support

Who has to report: • Any company providing prescription drugs in Australia

Where it has to be reported:

• Company website • Companies that do not have Australian websites must make

this information available upon requestAvailable Information:

• First report will be published on the Medicines Australia website in June 2013

1 Australian Competition and Consumer Commission


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The JPMA1 Released Transparency Requirements In March 2011 (Voluntary)

JPMA Requirements:

Payment Categories

R&D Studies and Post marketing studies

Aggregate Annual Amount

Speaker Programs, etc. Aggregate Annual Amount

Dining, Entertainment, Gifts Aggregate Annual Amount

Donations Annual Amount per Recipient

Honoraria (speaker/advisor) Annual Amount per Recipient

When First disclosure of 2012 payments in 2013

Where Company Website

1Japan Pharmaceuticals Manufacturers Association


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Croatia -- Code of Conduct Of Research-Based Pharmaceutical Companies

Transparency Requirements:

Adopted • October 13, 2011

Applies to • Healthcare professionals in the Republic of Croatia and to the interaction between healthcare professionals and pharmaceutical companies

• The promotion of prescription-only medicinal products

• Vaccines and devices What must be published • A List of Organizations to which it provides financial

support, and/or• Significant indirect/ non-financial support

Where to publish • Information may be provided at the national or European level

Timeline • Annually


23

Slovakia- Code of Conduct of Pharmaceutical Industry In Slovakia (Revised Version February 2012)

Slovakia Transparency Act:

Details to disclose • The list of patient organisations receiving company’s financial support and/or significant indirect/non-financial support

• List of patient organisations involved in provision of significant contracted services

• The total amount paid to each patient organization during the reporting period

Disclosure shall include

• A short description of the support• The financial value of the support and charged expenses• Basis of the agreement without the necessity of disclosing any confidential

information

Where to disclose • Company website (or on a website of the relevant association)

When to disclose • At least once a year, not later than March 31 of the following year

*PR/Legal/Consultant Disclosure

List indicating: •The name of PR agency or communication agency•Legal representative representing the company including ConsultantsWhen to disclose:•the disclosure shall be made without undue delay after signing the contract with the External Consultant and •shall be placed in the public domain, while the project is being done.


Full Members of EFPIA

Country OrganizationAustria Fachverband der Chermischen Industrie Osterreichs (FCIO)

Belgium Association Generale de I’lndustrie du Medicament (AGIM-pharma.be)

Denmark Laegamiddelindustriforeningen The Danish Association of The Pharmaceutical Industry (LIF)

Finland Laaketeollisuuus y/Pharma Industry Finland (PIF)

France Les Entreprises du Medicament (LEEM)

Germany Verband Forschender Arzneimittelhersteller (VfA)

Greece Hellenic Assocoation of Pharmaceutical Companies (SFFE)

Ireland Irish Pharmaceutical Healthcare Association (IPHA)

Italy Associazione delle imprese del farmaco (Farmindustria)

Netherlands Vereniging Innovatieve Geneesmiddelen Nederland (Nefarma)

Norway Legemiddelimdustriforeningen/Norwegen Association of Pharmaceutical Manufacturers (LMI)

Poland Employers Union of Innovative Pharmaceutical Companies (Infarma)

Portugal Associacao Portugeusa da Industria Farmaceutica (Apifarma)

Russia Association of International Pharmaceutical Manufacturers (AIPM)

Spain Asociacion Nacional Empresarial de la Industria Farmaceutica (Farmaindustria)

Sweden Lakemedelsindustriforeningen/ The Swedish Association of the Pharmaceutical Industry (LIF/Sweden)

Switzerland scienceindustries

Turkey Turkey Arastirmaci llac Firmalar Deregi (AIFD)

UK The Association of the British Pharmaceutical Industry (ABPI)


Company Members of EFPIA

Member Companies

Abbott Biogen Idec Eisai Merck Sharpe & Dohme

Lundbeck

Almirall Boehringer Ingelheim Eli Lilly Novartis Orion Pharma

Amgen Bristol Myers Squibb Genzyme Novo Nordisk Otsuka

Astelles Chiesi Farmaceutici GlaxoSmithKline Grunenthal Pfizer

AstraZeneca Daiichi-Sankyo Menarini Ispen Roche

Bayer Healthcare Esteve Merck Johnson & Johnson\ Sanofi