EFPIA DisclosureRights & Requirements to Consent Management

12 July 2016

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Ulf H. Grundmann Elisabeth Kohoutek

Rechtsanwalt | Partner Rechtsanwältin

King & Spalding LLP King & Spalding LLP

T +49 (69) 257 811 400 T +49 (69) 257 811 401

UGrundmann@kslaw.com EKohoutek@kslaw.com

Agenda

• Overview of the Global Transparency Landscape

• Examples of Specific European Union Disclosure

Obligations

• Publishing of Personal Data – Consent

• New Anti Corruption Laws in Germany

• Practical Considerations

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Global Transparency Landscape

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Overview of Disclosure Laws and Industry Codes

• Denmark, Estonia, France, Greece, Hungary, Philippines, Portugal, Romania, Slovakia, Turkey

International Disclosure

Laws

• 33 EFPIA member countries, Australia, Iceland, Japan, Luxembourg

International Disclosure

Codes

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Countries with Disclosure Laws or Industry Codes

Law

Industry Code

Both

Active

Pending

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Laws vs. Industry Codes

• Generally apply to marketing authorization holders, entities operating in the specific country, and/or entities providing benefits or other transfers of value to healthcare professionals from the country

• Scope of reporting entities and covered recipients tends to be broader

• Enforced by government authorities and often carry more severe penalties

• Often less guidance released by the enforcement authority

Laws (e.g., France, Portugal, Slovakia)

• Generally bind only member companies and those entities that voluntarily choose to be bound by the code

• Enforced by industry association and often require severe breaches to trigger monetary penalties

• Member engagement often leads to more aggressive outreach and guidance

Industry Codes (e.g., EFPIA, ABPI)

• Data privacy and consent concerns generally apply to both laws and codesNote

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EFPIA Disclosure Code

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• EFPIA is the umbrella pharmaceutical trade organization in the EU

― Members include over 30 EU industry associations and 40 pharmaceutical

companies

― Compliance with all EFPIA codes is required by members and non-members

voluntarily choosing to be bound

• Disclosure Code

― Approved in June 2014

― Requirements were transposed into each member association’s country code

― Significant uniformity between countries but some areas of variation (e.g.,

disclosure language, disclosure platform, consent requirements)

• Tracking of transfers of value was required to begin on January 1,

2015

• First reports due by June 30, 2016

― On member website or central platform (based on national code)

― Language is specified by national code

EFPIA Disclosure Code – Background

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• Track and disclose “transfers of value” (direct or indirect benefits in cash

or kind provided for promotional or other purpose) made to HCPs and

HCOs, subject to some exceptions

― “Healthcare professional” is defined to include European members of the

medical, dental, pharmacy or nursing professions or any other person who,

in the course of his or her professional activities, may prescribe, purchase,

supply, recommend or administer a medicinal product

― “Healthcare organization” is defined to include any legal person in Europe (i)

that is a healthcare, medical or scientific association or organization (e.g., a

hospital or learned society) or (ii) through which one or more HCPs provide

services

― Note: some member associations have altered the definition of HCP to

specifically include additional covered recipients (e.g., midwives, paramedics,

physician assistants, etc.)

EFPIA Disclosure Code – Basic Requirements

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EFPIA Disclosure Code – Basic Requirements

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Specific Reporting Categories

• HCPs: cost-contributions for events; fees for service and consulting

• HCOs: donations/grants; cost-contributions for events; fees for service and consultancy

• R&D Transfers of Value (clinical; non-clinical; prospective non-interventional patient data collection from/on behalf of HCPs) – disclosed in the aggregate

Exceptions

• OTC drugs (solely) involved

in transfers of value

• Items not listed in Code (e.g.,

items of medical utility)

• Meals and drinks

• Samples

• “Ordinary course purchases”

and sales of medicinal

products (e.g., product

purchases)

Transparency Laws and Industry Codes –Country Considerations

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Relevant Disclosure Obligations

• Disclosure obligations stem from Danish law

― Unique in that many of the reporting obligations are placed on the HCP

― Manufacturers have a duty to ensure that HCPs comply with their obligations

• Manufacturers must notify and receive permission from the Danish Health

and Medicines Authority (DHMA) any time a doctor, dentist, or pharmacist

becomes associated with the manufacturer

• Manufacturers must annually provide to DHMA and publish on their own

website a list of HCPs and organizations with which they collaborate

Country Considerations - Denmark

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Relevant Disclosure Obligations• Disclosure obligations stem from French law

• Manufacturers must report:

― All benefits, in cash or in-kind, with a value (all taxes included) of €10 or more provided directly or indirectly to covered recipients

Disclosures must be made by February and August 1st of each year

― Agreements with covered recipients

Disclosers must be made within 15 days of the signing

Note: In February 2015, the French Council of State ruled that certain elements of the implementing decree and circular were not aligned with the law. In response, the French Parliament passed a new law revising the disclosure obligations. The French Minister of Social Affairs and Health stated that a new implementing decree will be released.

Country Considerations - France

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Relevant Disclosure Obligations• Disclosure obligations stem from the industry code (FSA Transparency

Code) and apply only to member companies

― FSA is a member of EFPIA and the disclosure requirements mirror those requirements

• Pharmaceutical manufacturers must disclose, in relevant part:

― Transfers of value in connection with training events (e.g., registration fees, travel, and accommodation expenses)

― Fees for Service and Consultancy (including both remuneration of services and consultancy services and the outlays reimbursed in this connection - such as travel expenses)

Country Considerations - Germany

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Relevant Disclosure Obligations

• Disclosure obligations stem from the CGR Code of Conduct which applies

to a broad spectrum of industry associations, including: ― Innovative pharmaceuticals, generic pharmaceuticals, “self-care” medicines,

physicians, pharmacists, nurses, physician assistants, and druggists

• Pharmaceutical manufacturers must disclose:― All financial arrangements with HCPs that are worth more than €500 per year

― Reports must be submitted annually to the CGR central register by March 31

― Nefarma, the Dutch pharmaceutical industry association, received an exemption

from EFPIA with regard to the disclosure code – Nefarma members must follow

the CGR Code disclosure requirements

Country Considerations - Netherlands

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Relevant Disclosure Obligations

• Disclosure Obligations stem from the industry code (ABPI Code of Practice)

and apply only to member companies

• Pharmaceutical manufacturers must disclose, in relevant part:

― Transfers of value in connection with training events (e.g., registration fees,

travel, and accommodation expenses)

― Fees for Service and Consultancy (including both remuneration of services and

consultancy services and the outlays reimbursed in this connection - such as

travel expenses)

Country Considerations - United Kingdom

Publishing of Personal Data – Consent

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Publishing of Personal Data - Consent

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Restrictions on processing of personal data in the European Union

• Directive 95/46/EC on the protection of individuals with regard to the

processing of personal data provides restrictions on the processing of

personal data

• Personal data means any information relating to an identified or identifiable

natural person (Art. 2 (a) Directive 95/46/EC)

• Personal data of HCPs may be disclosed only if

― The HCP has unambiguously given his consent; or

― Disclosure is necessary for compliance with a legal obligation to which

the controller is subject (see Art. 7 Directive 95/46/EC)

Publishing of Personal Data - Consent

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• Member States where disclosing is not a legal obligation

― Companies must seek unambiguous consent of the HCP prior to

publishing personal data

― Consent must be

― Based on the HCP’s free decision

― HCP must be fully informed about purpose, type and scope of publication

― In general must be in writing

― Member States transposed Directive 95/46/EC into national Data

Protections Laws, which must be observed when processing

personal data in the respective Member State

Hot Topic – New German Anti-Corruption Laws

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German Anti-Corruption Laws - Background

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• Background

― Closing regulatory gap regarding improper influence at prescription, distribution or administration decisions of HCPs

― Anti-corruption laws did not cover resident physicians or any other independent or employed HCP (Decision of the Federal Supreme Court of March 29, 2012 in case file GSSt 2/11)

• New criminal offence “Taking and giving bribes in the health care sector”

― New Sections 299a and 299b Draft German Criminal Code introduced

― Entered into force on June 04, 2016

German Anti-Corruption Laws - Taking and Giving Bribes

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• Section 299a: Taking bribes in the health care sector

Whosoever as a healthcare professional, who is required to complete a state regulated education for his professional practice or for the use of his professional title, demands, allows himself to be promised or accepts a benefit for himself or another at the exercise of his profession as consideration for according providing an unfair preference in the

1. prescription of medicinal products, remedies or tools or of medical devices,

2. purchase of medicinal products, remedies or tools or medical devices, which are intended for direct use by the health care professional or his assistant, or

3. procurement of patients or examination material

shall be liable to imprisonment of up to three years or a fine.

German Anti-Corruption Laws - Taking and Giving Bribes

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• Section 299b: Giving bribes in the health care sector

― Section 299b of the new German Criminal Code inversely criminalizes pharmaceutical companies, who are offering or providing such gifts or benefits to HCPs

• Section 300:

― Section 300 of the new German Criminal Code foresees aggravated sentences in especially serious cases

EU Anti-Corruption Laws – Where is the Bottom Line?

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• Anti-Corruption Laws limited by European Law― National Anti-Corruption Laws must comply with European Law: National

Anti-Corruption Laws must not punish activities allowed by European Law

• Benefits granted to HCPs admissible as long as they are not likely to improperly influence those HCPs― Article 94(1) of Directive 2001/83 provides that no benefits must be supplied,

offered or promised to HCPs qualified to prescribe or supply medicinal products, unless they are inexpensive and relevant to the practice of medicine or pharmacy

― Prohibition seeks to prevent promotional practices which may induce HCPs to act in accordance with their economic interests when prescribing or supplying medicinal products (ECJ, Judgment of 22 April 2010 in Case C-62/09)

― Benefits granted to HCPs are only inadmissible, if they are likely to cause economic interests by prescribing or supplying medicinal products (German Federal Supreme Court, Judgment of 25 April 2012 in Case I ZR 105/10)

Practical Considerations

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Practical Considerations – High Level Considerations

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• High Level Considerations:― Assess potential transparency and disclosure obligations associated with an

interaction

― Transparency obligations can be based in law, industry code, or both

― Data privacy and consent issues should be considered

― Be aware of and sensitive to the applicability of anti-bribery laws, including the

U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act, Directive

2001/83/EC, and the German Criminal Code

― Comply with applicable local laws and regulations

― Comply with local trade association industry codes of associations of which

your company is a member

Non-member companies should also consider the principles enumerated in local

industry codes

― Comply with your own company policies and procedures

Practical Considerations – Collaborations with HCPs

• Practical considerations when collaborating with HCPs:

― Develop a process/protocol to help ensure that all relevant issues are considered when engaging HCPs

― Sensitize your colleagues to these issues to help avoid internal conflicts and confusion

― As a general matter, it would be good practice to document the legitimate purposes for why your company is engaging a particular HCP or covering travel, lodging, and/or registration fees for an HCP to attend an event

― For particular events, consider a lowest common denominator/most restrictive

approach to help avoid the need to implement varying value limits and other restrictions for each particular HCP at the event, depending on where he/she is from/licensed

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Practical Considerations – Reduce Risk of Prosecution

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• Practical considerations to reduce risk of prosecution:

― Ensure that possible consent requirements are met

― Review existing agreements with HCPs and internal corporate directives and amend accordingly with view to anti-corruption laws

― Be aware of special requirements for internal documentation, publications relating to granted benefits may constitute the beginning of a suspicion that would justify initiating criminal proceedings

Questions?

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Speaker Biography

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Ulf H. Grundmann

ugrundmann@kslaw.com

+49 69 257 811 400

Ulf GrundmannUlf H. Grundmann is partner in King & Spalding’s Life Science Practice Group

in Germany. His practice concentrates heavily on Medical Devices,

Pharmaceuticals, Cosmetics and Food Industries for almost twenty years.

Mr. Grundmann advises clients in the different stages of the life cycle of a product,

including product development, labeling, advertising and promotion, product

launch, distribution, licensing, compliance, aspects related to parallel importation,

protection against falsified products, recalls, if necessary and end-of-life.

He counsels clients in all areas of EU regulatory, unfair competition and

compliance law and represents clients before national and European authorities

including the European Commission. In addition he advises on corporate and

financial transactions related to life science companies with his expertise and

experience in life sciences regulatory law. Having actively practiced in the area of

litigation, in particular as appellate litigator, for many years, Mr. Grundmann is

very well-known for representing his clients in litigation cases before German and

European courts, including the General Court and the Court of Justice of the

European Union.

Prior to joining King & Spalding, Mr. Grundmann was partner with the

international law firm Bird & Bird and was leading their global Medical Devices

and Food & Beverages Sector Groups.

Speaker Biography

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Elisabeth Kohoutek

ekohoutek@kslaw.com

+49 69 257 811 401

Elisabeth Kohoutek

Elisabeth Kohoutek is a member of our FDA & Life Sciences practice

based in Frankfurt. She regularly advises household names in the life

sciences and food and beverage industries on litigation, intellectual

property and unfair competition issues.

Elisabeth Kohoutek advises both European and U.S. clients in the fields

of Intellectual Property and Unfair Competition Law, with a particular

focus on extra-judicial advice, litigation and arbitration. She mainly

advises clients in the food, pharmaceutical, medical devices and

cosmetics industries, focusing on regulatory work for these sectors.

Prior to joining King & Spalding Elisabeth Kohoutek was working for

the international law firm of Bird & Bird, where she was a member of

the Food & Beverage and Life Sciences Sector. Elisabeth Kohoutek

studied law at the University of Heidelberg and Barcelona. During her

legal clerkship Elisabeth worked for law firms in Frankfurt and New

York.

PhysicianConsentFocus

• Relationship & Access

Ned MumtazPractice Leader & Associate Partnerqordata

Speaker Biography

Ned Mumtaz

Ned.mumtaz@qordata.com

+1 201 753 1734

Ned MumtazNed Mumtaz is an associate partner and practice leader in qordata’s Life Science

Practice Group.

Mr. Mumtaz advises clients in assessing and creating systems and processes to develop software, programs and procedures to manage compliance and transparency spend data and support HCP data privacy solution.

Prior to joining qordata, Mr. Mumtaz was a director at leading global Pharmaceutical manufacturers in US including Eisai, Wyeth (now Pfizer), Schering Plough (now Merck) and others.

Mr. Mumtaz also lead the solution practice for pharmaceutical analytics for SAP America and EMC systems.

Pharmaceutical Compliance & Risk Management

Pharmaceutical corporations are

committed to doing business ethically.

Corporations also know that

compliance missteps could lead to

regulatory and legal risks.

Best Practice: Compliance leaders

anticipate risks, and they protect

against these risks.

EFPIA transparency directive & the RISK of violating data privacy laws

Progressive pharmaceutical compliance executives are focusing on partnering with HCPs and HCOs during this period of change, while others are just reporting on them.

Major Risks:• € 500,000 fine for violating data privacy laws.

• € 6,000 to € 360,000 fine for errors in disclosure report.

• Loss of Brand & Company reputation for failing to provide proper transparency.

• Loss of relationship & access to physicians.

Physicians Transparency & Physician Privacy

Physician’s point of view:

Dr. Klein has always done business ethically, and he is very busy practicing medicine, therefore he has paid scant attention to the EFPIA transparency directive and has agreed to freely consent to pharmaceutical manufacturers to disclose payments.

Physicians Dillema & Data Privacy

It is now Saturday, July 30th and Dr. Klein has taken notice of recent media noise claiming payments from Pharmaceutical corporations to HCPs and HCOs is serious business in EU where millions of Euros are exchanging hands.

Questions to consider on behalf of Dr. Klien.

How would the patients react in the coming months?

Should Dr. Klein have consented to spend disclosure?

Should he inspect the disclosed spend?

Should he have inspected the reports before they were published?

Could reporting errors create wrong judgment?

Could he track, verify and manage his consent status?

In general, physicians may be nervous about the impact to their business

from any negative publicity.

Industry has recognized the impact of data privacy on physician transparency.

qordata Confidential

How does European data privacy legislation impact on the disclosure code?

Nov 19th, 2015 by

Julie Bonhomme

Deputy Director, EFPIA

Transparency Is Key When Collaborating With Healthcare Professionals (Guest blog)

Jun 16th, 2016

Andrew Hotchkiss

President, Europe and Canada, Eli Lilly

and Company

Healthcare professionals support increased transparency – but will they disclose? (Guest blog)

Jun 8th, 2016

Karen Borrer (ABPI)

Quick Summary

Best Practice: Compliance leaders anticipate risks, and they protect

against these risks.

Progressive pharmaceutical compliance executives are focusing on

partnering with HCPs and HCOs during this period of change, while others are just reporting on them.

Physicians are nervous about the impact to their business from any

negative publicity. And they want:

• easy access to information being published.

• ability to manage the accuracy of data being published.

• manage accuracy and privacy of their data.

Business case & win/win

Skilled pharmaceutical compliance experts are anticipating the physician disclosure regulation from HCPs point of view and putting programs in place to protect their company’s relationship with their HCPs.

In the next few minutes I will share

what programs manufacturers may

consider to create for their physicians

and how these programs could help

partner with the physician

Partnering with the physician to manage spend and consent.

The best practice in managing data privacy and consent is to have an

electronic process that can:

(a) provide current and verifiable consent status every time all the time.

(b) electronically store consent, revocation, revisions, denials, etc.

(c) provide easy and 24 X 7 access to all stakeholders including HCPs.

(d) support verbal, phone, email, paper, digital and online processes.

(e) maintain SOPs that can attest to the above.

(f) updates transparency report across all 33 countries instantly.

(g) meet data privacy, data security, data recovery directives and laws.

…. blueprint of a Physician consent management system for the above….

illustrative solution

Consent Database

illustrative data content

Current State• collecting consent through paper or digital physician signature

• modifying contractual agreements to include physician consent

Challenge:

ability to handle multiple changes to consent

For example:

• declined consent (no response to consent request versus decline)?

• emailed consent note (date and items consented)?

• revoked consent in writing (link revocation to consent and relevant dates)

• verbally revoked consent by informing the sales representative in the

presence of a witness. (what happens? can you handle verbal revocations)

most organizations are challenged by these scenarios.

Ideal State

PhysicianEducation

Physician Consent

Management

PhysicianDispute

Management

Auto UpdateTransparency

Report

Physician Web Portal – Education, Consent, & Support

Physician Consent &Dispute Portal

Policy Statement FAQs

Join us for a live demo

Mobile Physician Consent Management

Auto Reporting and Tracking

• Executive dashboard

• Target VS Progress period

• Detailed tracking by:

– Country, City, Specialty, Rep, etc.

Automatic updates for transparency reporting

Update across all affiliates within 12 business hours. Both approval of new

consents and revocation of existing consent.

Current State VS Ideal State

Ease of Use- Paperless process

- Better physician experience

- Automated reporting

Secure- No risk of misplacing paper

- Secured “encrypted” storage

- Easy to store for several years

Accessible- Need for consent forms

- 24/7 availability for consent tracking & revocation

Robust - Handle new regulations

- Handle changes to consent text

Next Steps

A detailed presentation on creating the blueprints of a Consent management system & DEMONSTRATION of what the solution might look like.

What qordata offers:

• Solution Assessment and Remediation Services• Install ready built SOFTWARE solutions• Custom build SOFTWARE solution

Questions & Answers

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Physician Consent Management

Multi Channel Access

Access Channels

• Digital

• Phone

• Email

• Mail

• Paper

Storage

• Paper

• Digital

• Database

View and Use

• Mobile

• Web Portal

• Reports

SecureMultilingual

Interoperable

Encrypted

Offline Functionality

Cloud Master Data Enrichment

Physician Consent Management