Option 1: Ban DTCA

15. Under this option any advertising/promotion of medicines would be prohibited. Consumers would source information about such products from health care professionals and the instructions that accompany their medication or the Consumer Medicine Information (CMI) fact sheet.³ Consideration would need to be given to allowing advertising of medicines as part of public health campaigns, for example, flu vaccinations.

16. Thirty-four percent of submissions that indicated a policy preference supported banning DTCA.

Ease of implementation

17. Banning DTCA would require either an amendment to the Medicines Act 1981⁴ or provision in the Therapeutic Products Bill (although the Bill will not be ready for Government consultation until 2002).

Fiscal implications

18. Much of the debate surrounding whether to ban DTCA concerns fiscal arguments. Opponents to banning DTCA suggest that there would be a reduction in economic activity and employment in the advertising industry of up to $18 million a year if a ban was put in place.

19. Proponents of banning DTCA argue that advertising puts a fiscal pressure on Government pharmaceutical budgets and General Medical Subsidies (GMS) through increased doctors' visits and drug prescriptions. Research has indicated that physician visits increase for the conditions associated with advertised drugs during an advertising campaign, and that prescriptions for that drug also increase. However, this evidence of more frequent physician visits related to DTCA does not distinguish between people who require care and for whom treatment is beneficial, and people for whom there is little evidence of benefit. It also cannot be established whether unmet need was being met as a result of these visits.

20. It should be noted that over half of the drugs advertised are not subsidised by Pharmac. Between October 1999 and September 2000, 26 of the 46 drugs advertised were not on the Pharmaceutical Schedule.

21. Even if it is accepted that DTCA contributes to increased physician visits, and increased prescriptions, which may in turn put pressure on the pharmaceutical budget (for subsidised pharmaceuticals) it would be difficult to justify a ban on DTCA citing fiscal pressures, when
    1. we have no evidence that the increases in physician visits or prescriptions are beneficial or harmful to consumers

    2. responsibility for prescribing lies with the physician

Evidence of harm or health improvements

1. Extensive literature reviews of empirical research have found that no reliable evidence exists to support hypotheses of potential health benefits or potential harm resulting from DTCA.

Access to information

2. Proponents of DTCA argue that DTCA improves people's access to information and empowers them to seek treatment and be better informed about decisions. The issue though is not about access to information, but access to accurate and balanced information.

3. Submissions received on the discussion document, empirical research and Medsafe, have all shown that the quality of DTCA has not always been good. For example Medsafe reviewed DTC advertisements in February 2000 for compliance and found that only 69 percent of prescription medicines complied with the regulations and only 16 percent of over-counter-medicines complied. Compliance alone, however, does not indicate that an advertisement provides quality or balanced information.

4. Banning DTCA would ensure that consumers are not exposed to poor quality advertisements. However, this is an extreme measure considering that regulations can be changed to further regulate advertisements, for example, by prescribing the length of time that risk information must be displayed.

5. It is also argued that banning DTCA could lead to a paternalistic model of consumer access to information i.e. through doctor and pharmacist. If DTCA were banned, consumers could still access information from the internet and CMI.

Pragmatic considerations

6. Banning DTCA would not prevent consumers from accessing pharmaceutical information on the internet. However, submissions argued that consumers that have the motivation to search the internet for pharmaceutical information would also be likely to search out several different opinions.

7. Another pragmatic consideration is that a self-regulatory model is self-funding, requiring no funding from Vote Health. It is also argued by proponents of DTCA to be more flexible and faster acting than government regulation.

8. Once again, it is difficult to determine whether DTCA improves or undermines the doctor/patient relationship. Research of physicians in both America and New Zealand has shown that on the whole, doctor's opinions of DTCA tend to be negative.

9. Research has also shown that a high proportion of doctors honour patient requests for advertised drugs.⁵

Legal issues

10. The New Zealand Bill of Rights Act 1990, particularly section 14 which provides for the right to freedom of expression, was referred to by many submissions on the discussion paper.

11. Section 5 provides that the rights and freedoms contained in the Bill of Rights Act may be subject only to such reasonable limit prescribed by law as can be demonstrably justified in a free and democratic society. Legislation seeking to fully or partially ban DTCA would need to demonstrate a clear justification. Essentially, this would require the Government to demonstrate that any restrictions would serve a significant and important objective, and secondly, would require Government to show that the measure used to implement that objective was rationally and proportionally connected to that objective. Any measures taken to achieve this objective should impair the Bill of Rights Act 1990 to the least extent possible and that no other possible means were available to achieve the desired objective.

12. However, this is not to say that the Government cannot introduce legislation which is inconsistent with the New Zealand Bill of Rights Act 1990. The Government can, and has in the past, introduced legislation which is not consistent with the Bill of Rights Act 1990. Thus, when considering any legislative proposal, the emphasis must be on whether the proposal is justified from a policy perspective, not whether the proposal is consistent with the Bill of Rights Act 1990.

13. Regardless of this ability, given the lack of empirical evidence on the potential health benefits or potential harm resulting from DTCA it could be difficult to provide justification from a policy perspective to ban DTCA, and therefore justification to contravene the New Zealand Bill of Rights Act 1990.

Option 2: Status quo

14. The status quo option would continue to allow advertising of prescription medicines with the current legislative framework of the Medicines Act 1981 and self-regulation by the industry.

15. The status quo option was supported by 40 percent of the submissions that indicated a policy preference. All of the pharmaceutical and advertising companies who responded to the discussion paper were in favour of retaining DTCA under the status quo regulatory regime.

Ease of implementation

16. The status quo option would not require any legislative change, thus, no implementation would be required.

Fiscal implications

17. The status quo option would maintain the current economic activity and employment in the advertising industry.

18. This option would not reduce pressure on the pharmaceutical budget and GMS. Treasury has suggested that with the implementation of a capitation system as part of the Primary Health Care Strategy, Primary Health Organisations are likely to be required to manage a capitated pharmaceuticals budget, which could result in savings long-term.

Access to information

19. The status quo would not directly improve any issues about access to 'quality' information. Consumers would retain the right to receive information about the availability of products through channels other than the medical profession. Over time, the quality of information in advertisements may be improved through industry initiatives.

Pragmatic considerations

20. The status quo option would allow time for the mandatory pre-vetting TAPS system that was introduced in November 2000 to bed down. At this early stage, indications are that the TAPS system has contributed to an improvement on the provision of balanced and factual risk information in advertisements. Data provided by the Association of New Zealand Advertisers shows that since the introduction of the TAPS system, the number of advertisements vetted by TAPS has increased almost two-fold⁶. The status quo option would give the industry time to prove itself under its self-regulation regime.

Doctor/patient relationship

21. The status quo option would not change the current doctor/patient relationship.

Legal issues

22. The status quo option would be consistent with the New Zealand Bill of Rights Act 1990.

Option 3: Allow self-regulation DTCA but with stricter rules

23. This option would involve a continuation of DTCA with some tightening of the legislative framework. The principle of industry self-regulation would remain. This option would require changes to the Medicines Act 1981, as well as a review of the procedures currently used by the industry in its self-regulatory role. Alternatively, as the Government has agreed in principle that officials should begin work on a proposal to establish a joint trans-Tasman regulatory agency to regulate therapeutic products, any review could be undertaken as part of the work on a new Therapeutic Products Act. Officials are currently planning to have legislation ready for consideration by the Government in late 2002.

24. Some suggested changes to tighten DTCA legislation are:
    • Only allow advertisements in the media i.e. newspapers, magazines, radio and TV. Currently, drug companies are promoting pharmaceuticals by writing to individual patients, running competitions, giving free offers and paying for doctor's visits - none of which are vetted by TAPS.

    • Advertisements by pharmaceutical companies of brand names on vehicles could be banned because as they move, it is difficult to read the mandatory risk information.

    • Sponsorship of events by pharmaceutical companies using a brand name could be banned as this promotes a drug name, but without the responsibilities. Also the drug company has no control over news reports.

    • Fines for not complying with the legislation and regulations could be increased.

    • A Review of Regulation 8 of the Medicines Regulations 1984 to make it more sensible and practical to apply (see paragraph 51).

    • Specify the length of time for TV advertisements for the mandatory risk information to be specified, as well as the font size.

    • Require voice over of risk information (this is mandatory in the United States of America).

    • Shift the onus from the complainant having to find an example of the offensive advertisement, to the pharmaceutical company. It is very difficult for the public to be required to video an advertisement on TV in order to make a complaint about it. The TAPS system could be required to keep an archive of all advertisements that it approves so that if someone makes a complaint, they just need to say what was being advertised, and TAPS will provide a copy.

    • Require a fair balance of benefit and risk information (which is required in the United States of America).

Ease of implementation

25. Both the Ministry of Health and Medsafe would need to further investigate and consult upon the above suggested changes, which may take up to one year to complete. This option would involve considerable legislative review.

Fiscal implications

26. It is possible that legislative changes could lessen the pressure on the pharmaceuticals budget than the status quo option.

Access to information

27. Adopting the suggested changes to advertising regulations would enhance consumer access to accurate and balanced information.

Doctor/patient relationship

28. The option could put less pressure on the doctor/patient relationship.

Legal considerations and pragmatic considerations

29. It could be argued that if it is difficult to find cause for a ban, it may also be difficult to find cause for tightening regulations. However, given that arguments for DTCA rely on the right to inform customers of products, it is important for the Government to ensure that consumers receive accurate and balanced information. Also, it could be argued that in the absence of definitive research about the benefits and risks of DTCA, the Government should be cautious about the effects of DTCA and tightening of regulations could be justified.

30. Also, many of the proposed amendments would make the current regulations more practical and sensible to apply. For example, whether DTCA is banned or not, many submissions, both those in favour and those opposed to DTCA, commented that regulation 8 of the Medicines Regulation 1984 needs to be reviewed as it is difficult to apply to advertisements other than those in print. Regulation 8 requires that advertisements and labels of medicines contain the quantities of ingredients, authorised use of the medicine, precautions, contra-indications and adverse effects.