Frequently Asked Questions
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- 1 Please note that the references to Code sections relate to Edition 18 of the Code of Conduct, which is the current edition under which the transparency reports for 2015 – 2016 are made.
- 1.1 What types of events are included in the company educational event reports?
- 1.2 Why do companies undertake educational events or sponsor a third party to conduct an educational event?
- 1.3 What is an Advisory Board?
- 1.4 Who is a healthcare professional?
- 1.5 Who is a healthcare professional consultant?
- 1.6 I can’t find the healthcare professional consultant’s report. Where is it?
- 1.7 What is a Health Consumer Organisation?
- 1.8 What must be reported about Health Consumer Organisations?
- 1.9 I can’t find the Health Consumer Organisation report. Where is it?
- 1.10 Why is Medicines Australia publishing this information?
- 1.11 What’s the difference between ‘hospitality’ and ‘entertainment’?
- 1.12 Why can’t I find a report for all pharmaceutical companies in Australia?
- 1.13 Who will police the accuracy of company reports?
- 1.14 How can I tell from these reports whether an event or other activity has breached the Code?
- 1.15 What do I do if I want to make a complaint?
Please note that the references to Code sections relate to Edition 18 of the Code of Conduct, which is the current edition under which the transparency reports for 2015 – 2016 are made.
What types of activities are included in company transparency reports?
- Educational Event Reports – covers all educational meetings and symposia held or sponsored by that pharmaceutical company; these are reported every six months.
- Advisory Board Reports – covers all Advisory Board meetings, includes the aggregate fees paid by companies to healthcare professionals for their participation in Advisory Boards and any travel, accommodation and hospitality; these are reported every six months.
- Consultancy Reports – includes the aggregate fees paid to healthcare professional consultants, including any travel, accommodation and hospitality; this is an annual report for each calendar year.
- Health Consumer Organisation Support Reports – reports on the nature of companies’ relationships with health consumer organisations including the monetary value of any financial support; this is an annual report for each calendar year.
What types of events are included in the company educational event reports?
- Congress – these are extended educational meetings usually organised by a medical society or college, university or other non-pharmaceutical company entity.
- Symposium – is a meeting between a number of experts in a particular field at which papers are presented by specialists on particular subjects and discussed. Symposia may be organised by a pharmaceutical company as a separate educational event or as a satellite to another congress or conference.
- Satellite – meetings held in conjunction with international or Australasian congresses, under the auspice of a non-company entity.
- Grand Rounds – a formal meeting at which physicians discuss the clinical case of one or more patients. Grand rounds originated as part of residency training wherein new information was taught and clinical reasoning skills were enhanced. Grand rounds today are an integral component of medical education.
- Journal Club – a group of individuals (usually within a hospital setting) who meet regularly to critically evaluate recent articles in scientific literature.
- In-service – a set of lectures, tutorials or other formalised teaching within the hospital setting.
- Company event – an educational event organised by a pharmaceutical company for healthcare professionals.
Why do companies undertake educational events or sponsor a third party to conduct an educational event?
- Companies undertake educational events or sponsor a third party to conduct an educational event to improve the understandings of doctors and other healthcare professionals regarding the current developments in disease management.
- Patients benefit from the continuing education of doctors. Patients gain benefits of new treatment options, better control of risk factors, access to new drugs and expanded use for existing drugs, appropriate dosing, vital information about new safety developments, and potential interactions with other drugs.
- Reliable, timely access to such information is crucial for doctors, who are trusted by their patients to make sound prescribing decisions based on the most up-to-date information available.
What is an Advisory Board?
An “Advisory Board” is not defined in the Code. It is generally understood to refer to a meeting of healthcare professionals with specific expertise who are contracted to meet at regular intervals to provide advice to a company about the Company’s product or group of products. An Advisory Board for a given Product may be conducted for a number of years and the membership of the Board may vary over time. The meetings are commonly held at external venues.
Who is a healthcare professional?
Under the provisions of the Code of Conduct a healthcare professional is a member of a medical, dental, pharmacy or nursing profession and any other person who in the course of their professional activities may prescribe, supply or administer a prescription medicine.
Who is a healthcare professional consultant?
The Code defines a healthcare professional consultant as a healthcare professional who is engaged by a member company to provide services or advice for a fee, and who is not an employee of the company.
Here are some examples of the consultancies which must be reported. This list is not exhaustive.
- Developing and/or presenting a submission to PBAC or PBS.
- Developing a continuing education program.
- Writing or reviewing a scientific paper, promotional or educational material.
- Expert opinion provided by one or more healthcare professionals on an ad hoc basis.
- Independent grant review committee.
- Market research where the company has selected the healthcare professionals participating in the research.
I can’t find the healthcare professional consultant’s report. Where is it?
The first annual report of healthcare professional consultants must be submitted to Medicines Australia by 30 April 2014, covering activities commenced on or after 1 January 2013 or ongoing on that date. Thereafter, the report must be provided to Medicines Australia on an annual basis by 30 April each year covering the previous calendar year. Medicines Australia will publish the reports within two months of receiving them. Therefore the first healthcare professional consultant report will be published by 30 June 2014, and annually thereafter.
What is a Health Consumer Organisation?
The Code defines “Health Consumer Organisations (HCOs)” as not-for-profit organisations that represent the interests and views of consumers of healthcare. They may range from small volunteer groups to large organisations, and generally promote views that are independent of government, the pharmaceutical industry and professional health service providers.
What must be reported about Health Consumer Organisations?
Each Member Company must provide to Medicines Australia for publication on its website, a report listing Health Consumer Organisations to which it provides financial support and/or significant direct/indirect non-financial support. The published report must include:
- the name of the Health Consumer Organisation; and
- a description of the nature of the support that is sufficiently complete to enable the average reader to form an understanding of the nature of the support; and
- the monetary value of financial support and of invoiced costs. For significant non-financial support that cannot be assigned a meaningful monetary value, the published information must describe clearly the non-monetary value that the organisation receives.
I can’t find the Health Consumer Organisation report. Where is it?
The first annual report of support of Health Consumer Organisations, including the monetary value of support regardless of its level, must be submitted to Medicines Australia by 30 April 2014 and cover activities commenced on or after 1 January 2013 or ongoing on that date. Thereafter, the report must be provided to Medicines Australia on an annual basis by 30 April each year covering the previous calendar year. Medicines Australia will publish the reports within two months of receiving them. Therefore the first Health Consumer Organisation report will be published by 30 June 2014, and annually thereafter.
Why is Medicines Australia publishing this information?
We have listened to the criticism that we need to be more transparent about how we conduct educational meetings and symposia for doctors and other healthcare professionals and how we provide support to health consumer organisations. We accept that we have a responsibility to be fully transparent about these activities. Medicines Australia will continue to work closely with the ACCC to ensure we deliver on these commitments.
What’s the difference between ‘hospitality’ and ‘entertainment’?
Under the provisions of the Code of Conduct ‘hospitality’ means the provision of food and beverages. ‘Entertainment’ is the provision of diversion or amusement such as sporting events, the theatre, musical or cultural activities. ‘Entertainment’ is prohibited under the Code of Conduct.
Why can’t I find a report for all pharmaceutical companies in Australia?
As a condition of membership of Medicines Australia all Member Companies undertake to comply with all aspects of the Code of Conduct and to strictly adhere to the highest ethical standards for the industry. Some Member Companies have signed a verification statement to the effect that they did not hold or sponsor any educational events during the reporting period.
Non-member companies were not required to provide these reports as they are not governed by these Code requirements. Nevertheless, Medicine’s Australia strongly encourages all pharmaceutical companies in Australia to show the same level of transparency in their dealings with healthcare professionals.
The Generic Medicines Industry Association’s members are also regulated under a Code of Practice which came into force in March 2010. The current edition of the GMIA Code is the third edition, which commenced in November 2013. The GMIA Code of Practice requires members to report educational events in a similar manner to the Medicines Australia Code of Conduct. These reports can be viewed on the GMIA website
Who will police the accuracy of company reports?
All companies have provided Medicines Australia with a signed verification statement “that the company has made all reasonable enquiries and to the best of their knowledge, the information in the educational event report is accurate and contains all educational meetings and symposia as defined in Section 9 of the 17th Edition of the Code held or sponsored by the company in the reporting period”.
Companies have a strong incentive to ensure the reports they submit to Medicines Australia for publication are comprehensive and accurate. Ultimately, member companies have an interest to ensure the ACCC requirement is met in full because authorisation of the Code of Conduct depends on it. Because information about educational events is now in the public domain, the omission or misrepresentation of any relevant detail is likely to be identified by some of the healthcare professionals who attend these events.
How can I tell from these reports whether an event or other activity has breached the Code?
The Code has sections pertaining to the provision of hospitality (Sections 9.4.3 and 9.5.5 ), entertainment (Sections 9.4.6 and 9.5.8), venue selection (Section 9.4.2 and 9.5.4), travel (Section 9.4.4 ), accommodation (Section 9.4.5 ), educational events (Sections 9.3 and 9.4) and sponsorship (Section 9.7). Section 9.8 and 9.10 govern consulting arrangements with healthcare professionals and Advisory Boards. Section 14 Governs relationships with Health Consumer Organisations.
Information on these sections can be found in the latest edition of the Medicines Australia Code of Conduct
The decisions of the Code of Conduct Committee in relation to educational event reports can be viewed in the Code of Conduct Annual Report (Note: the first reporting period was 1 July-31 December 2007).
In reviewing a complaint in relation to an educational event, held or sponsored by a pharmaceutical company, the Code of Conduct Committee considers a range of factors. For example:
- Was the primary objective of the event the enhancement of medical knowledge?
- Was the hospitality consistent with the professional standing of the audience but not extravagant?
- Was the venue suitable for the attainment of the primary objective of enhancing medical knowledge?
What do I do if I want to make a complaint?
Complaints are accepted from healthcare professionals, members of the general public and pharmaceutical companies. Information on lodging a complaint can be found on the Lodging and Responding to a Code of Conduct Complaint section