Jane Wurth, Medical Technology Association of Australia - Ethical Dealings with Industry: The Medical Technology Industry Code of Practice

Ethical Dealings with Industry: The Medical Technology Industry Code of Practice

Jane Wurth, Code of Practice

Manager 5 August 2015

About MTAA •  National industry body of the medical technology

industry •  Represents manufacturers, suppliers and

distributors •  Members supply majority of the

non-pharmaceutical products used in the diagnosis and treatment of disease and disability in Australia

•  Secretariat with 14 staff

Medical Technology Industry Code of Practice

•  Code of Practice began in 2001. 9th edition came into effect 1 January 2015

•  Was renamed the Medical Technology Industry Code of Practice in 2012 (formerly the MTAA/MTANZ Code of Practice)

•  Is subject to an external review every three years, to ensure it continues to reflect community, industry and regulatory standards

•  Community expectation that healthcare professional decisions are made in the patient’s best interest and aren’t swayed by inappropriate inducements

•  Industry can meet this expectation if they work within a strong ethical framework

•  A voluntary industry code is a flexible, industry-led way of creating this ethical framework

•  Can help manage corruption risks •  The primary objective of the Code is to maintain

community (HCP and patient) trust and confidence in the MedTech industry

Value of an industry code

Code coverage •  The Code is a voluntary industry code •  Binding on member companies of MTAA

through constitution •  Non-members encouraged to apply Code

principles •  In addition, some third parties require their

suppliers to follow the Code e.g. South Australia Health

Why is the Code important?

The Code aims to help companies:

•  Promote therapeutic goods ethically •  Provide high-quality, safe products •  Be transparent and accountable •  Respect the ethical obligations of

individual HCPs •  Uphold the ‘spirit’ of the Code •  Has a monitoring function in place, as

well as a complaints mechanism

The Code in context

Global scrutiny - US

•  2007: Five medical device companies disclosed charges under the Foreign Corrupt Practice Act in the United States

•  2009: Lanny Breuer, US Assistant Attorney General, US Department of Justice Criminal Division:

•  In 2014, the DOJ cracked down on device makers with $100M

+ in fines •  Individuals have also been prosecuted

We will be intensely focused on rooting out foreign bribery in your industry

Global scrutiny- UK

•  2011: UK Serious Fraud Office charges a former Vice President of Market Development at a medical device company with conspiracy to corrupt

•  Related to corrupt payments to Greek healthcare professionals in connection with sale of medical devices

•  The employee received a suspended sentence

Australia …aggressive marketing and lobbying of doctors under the guise of education. In the past this has included flying doctors to events in tropical locations overseas, paying for them to attend congresses and seminars held at 5-star resorts next to golf courses and hosting lavish lunches and dinners for prescribers. Other pharmaceutical company largesse includes appointing influential doctors to advisory boards and lucrative speaking engagements, including at overseas events.

Senator Di Natale – Explanatory memorandum for the Therapeutic Goods Amendment (Pharmaceutical Transparency) Bill 2013

Australia

Consumers Health Forum submission in response to Australian Government position paper on the promotion of therapeutic goods (2010)

...the ethical promotion of therapeutic goods is essential if consumers are to be confident that their health professionals’ decisions are based only on the consumers’ best interests, rather than on inappropriate incentives or marketing strategies.

How does the Code affect me and my staff?

Why do we need a Code?

•  The MTICOP is different from other industry codes, due to the unique, ‘hands-on’ relationship between company representatives and HCPs, and the need for this relationship to be based on trust, integrity and patient well-being

•  Company representatives are often present in theatre, and provide high-level technical support

•  The development and evolution of medical technologies is a collaborative process between companies and HCPs

What HCPs should expect from companies that follow the Code

•  The company must: •  undertake and encourage

ethical business practices and socially responsible conduct

•  not use any inappropriate inducement

•  not offer any personal benefit or advantage in order to promote or encourage use of its products.

Company-sponsored Training and Education and Medical Technology Demonstrations

•  Must be conducted in conducive setting for the effective transmission of knowledge – not selected because of its Entertainment, leisure or recreational facilities

•  Venue choice: consider whether public would consider venue to be conducive to learning

•  If ‘hands on’ training included: •  must be at a training facility, medical institution,

laboratory •  training staff to have proper qualifications and

expertise

Company-sponsored Training and Education and Medical Technology

Demonstrations

•  Company may pay for reasonable travel and modest accommodation and hospitality for attending HCPs

•  No support for guests of HCP •  Can’t require HCP to purchase/recommend product

as consideration for attendance •  No free products unless in accordance with the Code

The Code in action

Q: Could a company hold a consultants meeting at the rugby?

Sponsorship of Third Party Educational Conferences

•  Companies cannot directly fund individual healthcare professionals to attend Third Party Educational Conference

•  Companies can provide sponsorship/grant to the conference organiser

•  Sponsorship or grant may be used to: •  reduce conference costs (i.e. general subsidy) •  provide for attendance by a HCP or Practitioner in

Training (company can’t direct which HCP should attend)

•  contribute to reasonable conference speaker costs.

Sponsorship of Third Party Educational Conferences

•  Companies should also take the appropriateness of the geographical location into account when making the decision to support an event, whether this is by way of leasing a booth space for Company displays or any other form of event advertising or support

The Code in Action

Hypothetical sponsorship request: Agenda for Days 1 and 2 6.30-9.30am: conference sessions 9.30am-4pm: snow report and free time 4-7pm: conference sessions

Engaging HCPs as Consultants Selection of the consultant: • need for services must be genuine, related to the company’s products and identified in advance. • promotion of products can’t be a purpose for engaging a HCP as a consultant. • Consultant must be selected based on qualifications and experience, not volume or value of business that HCP has generated or could potentially generate. • cannot create a consultancy to circumvent the prohibition on direct funding of HCPs to conferences (e.g. sending HCP to speak at company symposium when not needed).

Engaging HCPs as Consultants

Expenses and compensation: •  HCP can be paid reasonable compensation at fair

market value. •  reasonable and actual expenses can be paid for. •  no side trips allowed: companies cannot fund or

facilitate a side trip from a consulting engagement if the HCP will get a personal/private benefit from the side trip.

Hospitality

•  Companies can only provide Hospitality (food and beverages) to Healthcare Professionals in limited circumstances.

•  The permitted circumstances are: –  in context of a Third Party Educational Conference –  where it is incidental to the bona fide presentation

of scientific, educational or commercial information.

Hospitality •  Hospitality cannot be provided where it may

constitute an inducement or appear to the public to be an inducement.

•  Hospitality acceptable as occasional courtesy if it: •  is incidental to purpose of interaction •  does not include entertainment (e.g. music or

sporting events) •  takes place in appropriate setting (not

recreational) •  modest in value (also consider public perception) •  is not provided to any HCP guest or other person

who does not have a professional interest.

Gifts

•  Occasional gift permitted with item that: •  benefits patients or serves genuine educational

purpose for the HCP •  Is under $100 (other than medical textbooks or

anatomical models). •  Non-educational branded items not permitted as gift

to Healthcare Professionals, even if modest in value (this rule does not apply to medical technology marketed only to consumers).

•  Samples are permitted for genuine training or evaluation purposes.

The Code in Action

Q: Can a company provide HCPs with branded stationary? Is a pen okay? What about a wall planner?

The Code brochure What to expect from companies: •  Ethical behaviour •  Product education and in-

service training in a learning environment

•  Most hospitality associated with product education

What companies may not do: •  Provide direct funding to

attend a conference •  Provide hospitality except

in the context of product education or in-service training, or by sponsoring hospitality at an educational conference

Companies may: •  Provide support for

educational conferences but only by providing sponsorship to the conference organiser and not individual participants

•  Provide research and educational grants but only to institutions established for that purpose

•  Donations to charity

Companies may not: •  Pay the cost of travel,

hospitality or other expenses for partners or family members

•  Pay for participation in or attendance at a sporting event or other entertainment

•  Provide any gift unless it benefits patients or serves an educational purpose and is minimal in value

•  Provide any form of branded promotional item

Further information

Jane Wurth Code of Practice Manager [email protected] or 02 9900 0626 Training queries should be directed Fiona Shipman at [email protected] or 02 9900 0640