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Therapeutic Goods Amendment (Pharmaceutical Transparency) Bill 2013

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2010-2011-2012-2013

 

 

 

 

THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA

 

 

 

 

THE SENATE

 

 

 

 

 

Therapeutic Goods Amendment (Pharmaceutical Transparency) Bill 2013

 

 

 

EXPLANATORY MEMORANDUM

 

 

 

 

(Circulated by authority of Senator R Di Natale)

 

 

 

 

 

 



 

 

Therapeutic Goods Amendment (Pharmaceutical Transparency) Bill 2013

 

OUTLINE

 

The Therapeutic Goods Amendment (Pharmaceutical Transparency) Bill 2013 is being introduced in order to safeguard the integrity of prescribing medicines in Australia.  The integrity of Australia's health system is of paramount importance in maintaining quality of care and the sustainability of health expenditure. It is important that we maintain this integrity and ensure that pharmaceutical companies are not having undue influence on the prescribing habits of doctors through gifts and other inducements disguised as education. This bill seeks to regulate this behaviour.

 

Currently the marketing of regulated pharmaceuticals to consumers is banned under the Therapeutic Goods Act 1989 . However, drug companies are free to communicate with the doctors that prescribe medicines. While doctors need up-to-date information on new therapies, drug companies have the added incentive of maximising the number of prescriptions written for some medicines. This can lead to 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.

 

This behaviour has tarnished the reputation of the pharmaceutical industry. There is some acknowledgement by the industry that perceptions of undue influence on prescribing patterns do exist, and there is some momentum to limit this behaviour and improve the image of their profession. A recent update to the Medicines Australia Code of Conduct strengthened the restrictions on these sorts of promotions. However, the Code does not, for instance, specify that medical practitioners who receive any form of largesse from drug companies should be named. The Code only covers members of Medicines Australia and participation is voluntary. 

 

The proposed Act will replace the industry code with legislation that sets more stringent restrictions on the interactions between pharmaceutical companies and physicians that minimises the opportunity to provide inducements and thereby unduly influence prescribing behaviours. The bill forbids payment for doctors to travel or attend education seminars and scientific conferences domestically and overseas, bans the sponsorship of educational meetings intended for Australian doctors outside Australia, limits gifts and overly lavish hospitality, and requires full reporting of any fees paid to prescribers outside the company.

 

NOTES ON CLAUSES

 

Clause 1 - Short Title

 

1.       This is a formal provision specifying the short title.

 



 

Clause 2 - Commencement

 

2.       This clause indicates that the Act will commence the day it receives Royal Assent.

 

Clause 3 - Schedules

 

3.       This clause provides that an Act that is specified in a Schedule is amended or repealed as set out in that Schedule, and any other item in a Schedule operates according to its terms.



 

 

 

Schedule 1 - Amendment of Therapeutic Goods Act 1989

 

 

Item 1

 

This item amends the title of Chapter 5 of the Act to make reference to inducements.

 

Item 2

 

This item inserts several new sections into the Act which define new offences related to the provision of money, services, or other possible inducements to medical practitioners by pharmaceutical companies.

 

Proposed section 42DQ inserts definitions used in new sections.

 

Proposed section 42DR specifies that certain inducements are prohibited and provides a penalty for making such inducements.

 

Proposed subsection 42DR(1) has regard to seminars or conferences that take place overseas and makes it an offence for a pharmaceutical company to arrange or sponsor a conference or educational seminar for Australian doctors that takes place overseas. It does not prohibit companies from hosting events within Australia, or for hosting events overseas that are not aimed primarily at Australian prescribers (doctors), nor does it prohibit Australian doctors from attending events outside Australia. This is intended to curtail the possibility of hosting an educational event in a tropical or otherwise exotic location which may act as an inducement.

 

Proposed subsection 42DR(2) is intended to otherwise place limits on overly lavish hospitality. Specifically, subparagraph 42DR(2)(b)(i) specifies that the company may only spend $100 per head on catering and entertainment, but subparagraph (2)(b)(ii) allows for a higher value to be prescribed in regulations, to allow for inflation or adjustments that otherwise fix the value in line with the educational purpose of these events.

 

Proposed section 42DS creates new offences related to unreported inducements provided by pharmaceutical companies to medical professionals.

 

Proposed subsection 42DS(1) specifies that a pharmaceutical company cannot pay for a medical practitioner to attend a conference or seminar, including travel or accommodation costs, unless that medical practitioner is a representative of the company sponsoring the event. In the event that a company does provide travel, accommodation or other recompense to a medical practitioner to attend the event on their behalf, that compensation is a reportable payment and must be reported under the requirements of section 42DT.

 

Proposed subsections 42DS(2) clarifies what it means for a sponsoring company to make a payment to a registered medical practitioner, including paying for a practitioner to attend an event,  paying a fee, paying for research, making a donation or giving a gift.

 

Proposed section 42DT outlines the new requirements regarding the reporting of payments to medical practitioners.

 

Proposed subsection 42DT(1) specifies that regulated corporations, i.e. pharmaceutical companies as defined in section 42DQ, must prepare an annual report and make it public.

 

Proposed subsection 42DT(2) specifies that for each reportable payment, as defined in section 42DQ, the report must detail the amount, recipient, date, and the reasons the payment was made. These reasons might include a description of services rendered in exchange for the payment. The medical practitioners receiving the payments are to be named individually, as specified in paragraph 42DT (2)(a)(ii).



Proposed subsection 42DT(3) specifies that the report is to be made public on the website of the corporation, no later than 1 month after the end of the financial report and for 5 years thereafter.

 

Proposed subsection 42DT(4) outlines in detail which payments constitute reportable payments. This includes any fee or honorarium paid to a medical practitioner or his or her employer; providing a service; paying travel or accommodation; providing funds to be used for research; making a donation to charity or giving any gift with a value over $25.

 

Proposed subsection 42DT(5) provides exceptions to the above for medical practitioners who are employees of the company or otherwise engaged by the company for the majority of their time. The corporation does not have to report the remuneration of employees who are registered medical practitioners, but must do so if those doctors are engaged on an ad hoc or part-time basis.

 

The reporting requirements in section 42DT to do not apply to payments made to any individual who is not a registered medical practitioner. These provisions are intended, in the public interest, to discourage payments and other incentives that may unduly influence prescribing behaviour, but not to otherwise place restrictions on commerce between drug companies and individuals in the normal course of affairs.

 

Section 42DU specifies the penalty for failure to provide the report as required at 3,000 penalty units.

 

Item 3

 

Clause (1) specifies that sections 42DR and 42DS relating to prohibited inducements and unreported inducements apply to acts or omissions beginning on 1 January 2014.

 

Clause (2) specifies that where an act contravening these sections is alleged to have occurred between two dates, one of which is before 1 January 2014, it shall be considered to have occurred before that date.



 

 

Text Box: Statement of Compatibility with Human Rights
 Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
 
 Therapeutic Goods Amendment (Pharmaceutical Transparency) Bill 2013
 This Bill is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
 
 
 Overview of the Bill
 This Bill amends the Therapeutic Goods Act 1989 to place restrictions on the way that pharmaceutical companies may interact commercially with doctors and creates the requirement for more transparent reporting of such interactions.
 
 Human rights implications
 This Bill does not negatively impact on any human rights. Although it places some small constraints on how pharmaceutical companies may compensate doctors, most interactions continue to be allowed under new transparency rules and there are no restrictions on the actions of individuals. These restrictions do not conflict with any of the rights enumerated in the applicable treaties.