Amanda Turnill, Baker & McKenzie - The push for greater transparency in dealings between the...

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© 2014 Baker & McKenzie

The push for greater transparency in dealings

between the pharmaceutical industry and HCPs –

where to now?

Amanda Turnill

Partner & Co-chair, Australian Life Sciences Group

7th Annual Pharmaceutical Law Summit

© 2014 Baker & McKenzie 2

Overview

‒ Why is there enhanced self-regulation and

transparency for dealings with HCPs?

‒ Developments in US/EU regarding transparency

‒ MA’s move towards greater transparency

‒ Developments in clinical trials transparency

‒ Challenges for industry going forward


Current Developments - Transparency


Why is there an increasing focus on

transparency internationally?

‒ Anti-bribery and anti-corruption impetus for US, UK

and other governments

‒ Existence of criminal offences for bribery and

corruption of foreign officials

‒ Prohibition on providing benefits to a person, intending

to influence a foreign public official in the exercise of

their duties to obtain or retain a business advantage

‒ Includes healthcare providers at public hospitals &

health department staff


Recent developments in the US

& EU: a push towards greater

transparency


USA – the “Sunshine” Act, Jan 2013

‒ The Physician Payments Sunshine Act

requires HCPs to report funding sources

‒ Purpose: to increase safety by increasing

transparency in conflicts of interest

between HCPs and outside interests

‒ Physicians report payments to Centers for

Medicare and Medicaid Services (CMS)

‒ Payments reported publicly on a website

due to be published by Sept 30, 2014


EU - EFPIA Code on Transfers of Value

from Pharma Cos to HCPs & Healthcare

Orgs, June 2013

‒ Requires EFPIA members to document

and disclose on websites names of HCPs

and associations that received payments

‒ Disclose all transfers of value (start in

2016 for previous year)

‒ Publish amount paid and type of

relationship

‒ Prohibition on gifts (money or benefits in

kind)


Australia: a steady move

towards greater transparency


What regulates pharmaceutical promotion to HCPs

in Australia?

To healthcare providers Direct to consumer

Prescription OTC Prescription OTC

Medicines Australia

Code of Conduct

ASMI Code of Practice Prohibited under the

Therapeutics Goods Act

Therapeutic Goods

Advertising Code

Australian Consumer

Law

Australian Consumer

Law

Australian Consumer

Law


& Regulations


& Regulations

Australian eMarketing

Code of Practice

Health Practitioner

Regulation National Law

Health Practitioner

Regulation National Law


& Regulations


Code of Practice


Code of Practice

Privacy Act 1988 (Cth)

Privacy Act 1988 (Cth) Privacy Act 1988 (Cth)


Transparency: Current Code Obligations

‒ s9.10: Must provide to MA aggregate details of fees

paid to HCPs in Australia, or to their employers on their

behalf, for certain services rendered

‒ Includes all consultancy services provided (includes

educational meetings, preparation of promotional

materials or product position papers, chairing and

speaking at educational meetings, assistance with

training and participation in advisory boards or other

therapy advice, but not R&D)


Transparency: MA Code of Conduct Review

‒ Transparency a key focus in

Australia with the Code review

‒ Transparency Working Group

set up and Consultation &

Discussion Paper published

‒ Transparency Model informed

by Transparency Principles

‒ Model emulated Sunshine Act


Transparency Model – Proposed changes

‒ A company supplying prescription medicine in Australia

must report direct and indirect payments or other

transfers of value provided to a HCP during the

preceding calendar year

‒ Key changes suggested in the model:

Identities of HCP recipients to be reported.

Payments to be categorised (travel, education etc.).

HCPs can request information about payments to 3rd

parties


Significant transparency changes to

reporting obligations in Code, Edn 18

‒ Code review process now finished but still to gain

members’ endorsement of suggested amendments

‒ Proposed changes: a watershed in transparency for the

Australian pharmaceutical industry

‒ Revised Code imposes strict obligations on companies

similar to the Sunshine Act, ie to report benefits given to

individual HCPs

‒ MA to vote on applying for ACCC authorisation


Developments in clinical trial

transparency


Background

‒ Clinical Trial Transparency is not new

‒ Arguments in favour include:

Many volunteers participate in trials to help

increase medical knowledge, so a failure to report

trials betrays their trust

Failing to report trials fully, results in biased

estimates of treatment effects and leads other

researchers up blind alleys

Precious time and resources can be wasted when

not all data is available


Australia, New Zealand & the US

‒ Australia & New Zealand: voluntary regimes for

registration of clinical trials

‒ Australian New Zealand Clinical Trials Registry

(ANZCTR) is the main registry

All trials registered are made public

‒ US: mandatory system for certain clinical trials

(www.clinicaltrials.gov):

One of the first, and the largest registry in the world

Holds 150,000 trials from more than 175 countries

Penalties for failing to register or submit results


Recent developments - EU

‒ The move to mandatory transparency measures is

gaining momentum internationally

‒ In April, EU member states voted to introduce laws

facilitating transparency regarding clinical trials

Changes include mandatory registration for all EU drug

trials, and reporting and publication obligations

Overwhelming majority of members of the European

Parliament voted in favour (547 vs17)

Financial penalties for non-compliance


Jan 2014: Principles For Responsible

Clinical Trial Data Sharing implemented

Principles issued by EFPIA and PhRMA

Adopted 5 key commitments:

Enhancing data sharing with researchers;

Enhancing public access to clinical study information;

Sharing results with patients who participate in clinical

trials;

Certifying procedures for sharing clinical trial information;

and

Reaffirming commitments to publish clinical trial results


Initiatives of Pharma Companies

Open Data Access Project

Clinicalstudydatarequest.com - sponsors committed to

this site: include Bayer, Boehringer Ingelheim, GSK,

Novartis, Roche, Sanofi and ViiV Healthcare

Other companies use their own portal eg Merck’s clinical

trials site


Where to for Australia?

‒ Likely Australia will move towards a mandatory

registration system

‒ Other considerations:

Australia has a mass of ad hoc registries in addition to

ANZCTR

Hard to harmonise information & track all relevant trials

CTAG Report (2011) recommended a move toward

transparency but implementation still to occur

Strong campaigning locally to improve transparency


Australia – ad hoc registries

• Australasian Registry Network for Orphan Lung Disease (ARNOLD)

• Australian Cancer Trials

• Australian General Practice Network Australian Lung Foundation:

• Black Dog Institute

• Cancer Institute NSW

• Cancer Research Network: in the University of Sydney

• Victorian Cancer Trials Link

• Cancer Trials Australia:

• Clinical Trials Connect

• ConnectClinical:

• Q-Pharm Pty Ltd

• Register4

• Trialspotting:

• IFPMA Clinical Trials Portal

• International Clinical Trials Registry Platform


Challenges for industry going

forward


Transparency – questions to ask

‒ Do we have an up to date compliance regime in place (ie for MA

transparency obligations and anti-bribery/anti-corruption)

‒ Privacy – how do we ensure privacy requirements are complied with

when collecting HCP’s personal details for purposes of disclosure under

the Code

‒ How do we obtain consent from HCPs for collecting their data (to be

disclosed to MA)

‒ Do we have Compliance Guides with relevant case studies & real world

examples?

‒ How do we train sales staff in the new transparency requirements?

‒ How do we identify & avoid corruption and non-disclosure risks?

‒ How do we monitor sales staff to ensure they are complying with our

policies (& are “doing the right thing”)?

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