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Direct-to-consumer advertising rules stricter

14 August 2001 Media Statement

Direct-to-consumer advertising rules will become stricter


Health Minister Annette King says pharmaceutical companies will become subject to tighter controls in terms of advertising their medicines direct to consumers.

"Over the past five years direct-to-consumer drug advertising (DTCA) has become increasingly common. The increased prevalence of direct advertising has raised concerns among health professionals about a range of issues, and these concerns led to a review that began last year," Mrs King said.

"After considering submissions made during the review, including those from consumer groups and organisations like the New Zealand Medical Association, and after receiving advice from the Ministry of Health, I have decided such advertising should continue to be allowed, but with tighter regulation."

Mrs King said at present medicine advertisements must comply with a number of different laws, industry self-regulation, and the Code of Therapeutic Advertising introduced by the Advertising Standards Authority in 1996. Medsafe, a division of the Ministry of Health, monitored compliance.

Mrs King said the principle of industry self-regulation would continue, but over the next year there would be consultation on a number of options for changes to the law.

"It is recommended by the Ministry that legislation regulating DTCA should be strengthened to ensure advertisements provide balanced information to consumers. Any changes that occur could be undertaken either as an amendment to the Medicines Act 1981, or in relation to work being done on a new Therapeutic Products Act. "

Mrs King said some changes that had been suggested include:
- Only allow advertisements in broadcast and print media (drug companies are now also promoting drugs by writing to individual patients, running competitions, giving free offers and paying for doctor visits).
- Banning brand names of drugs on vehicles.
- Banning sponsorship of events using the brand name of a drug.
- Fines could be increased for not complying with legislation and regulations.
- Specify the length of time to be allocated to mandatory risk information in television advertisements, as well as the font size.
- Require voice-over of risk information, a mandatory requirement in the United States.

"The debate around direct-to-consumer advertising has been extremely vigorous. Making evidence-based policy is not easy, as there is little empirical evidence to support either side of the debate, and the views on both sides of the debate are diametrically opposed.

"However, there is some evidence to show DTCA does increase doctor visits and prescriptions, and I believe that health professionals in New Zealand will support industry self-regulation provided we ensure tighter rules."

Ministry of Health report on policy options attached.


HEALTH REPORT

Subject: DIRECT TO CONSUMER ADVERTISING OF PRESCRIPTION MEDICINES ¡V POLICY OPTIONS

Date: 14 August 2001 File Ref: TT 05-18-11-0

Attention: Hon Annette King (Minister of Health)

Copy to: Hon Tariana Turia (Associate Minister of Health)
Hon Ruth Dyson (Associate Minister of Health)


EXECUTIVE SUMMARY
In 2000 you directed the Ministry of Health to review the existing policy on direct-to-consumer advertising (DTCA) of pharmaceuticals and provide advice on whether there should be changes to the current regime. On 31 November 2000 the Ministry of Health released a public discussion paper that invited comment on four policy options:

1. Ban DTCA
2. Retain DTCA under the current rules and regulations of the Medicines Act 1981 with continued self-regulation by the industry (status quo)
3. Retain DTCA under more stringent rules and regulations than are presently in place, and continue with industry self-regulation
4. Retain DTCA under more stringent rules and regulations than are presently in place, with regulation by a government agency.

The arguments raised for and against DTCA are diametrically opposed, with much of the debate taking the form of claim and counter-claim. The Ministry of Health believes little empirical evidence exists to support either side of the DTCA debate.

The Ministry of Health recommends option 3, allowing the continuation of DTCA of prescription medicines, but under more stringent rules and regulations and with continued industry self-regulation.1 Due to limited empirical evidence, it is difficult to justify banning DTCA on the basis that DTCA directly harms consumers. Given this lack of evidence, it would also be difficult to provide a ¡¥demonstrable justification¡¦ to ban DTCA in terms of the New Zealand Bill Rights of Act 1990.
However, there is some evidence to show that DTCA does increase doctor visits and prescriptions. It is recommended that the legislation regulating DTCA should be strengthened to ensure that DTC advertisements provide balanced information to consumers. This legislative review and subsequent change could be undertaken either as an amendment to the Medicines Act 1981 or in relation to the work being done on a new Therapeutic Products Act which is to be ready for government consultation by late 2002.

RECOMMENDATIONS
The recommendations are that you:

(a) Note that the Ministry of Health received 43 submissions on the ¡¥Direct-to-consumer Advertising of Prescription Medicines in New Zealand¡¦ discussion paper, with an almost even split of submissions between in favour of DTCA and those against DTCA
(b) Note that any policy decision on DTCA will be contentious and will attract media interest and that upon indicating your preferred policy option, the Ministry of Health will prepare a media communications package
(c) Note that very little empirical evidence exists to support hypotheses of potential health benefits or harm from DTCA
(d) Note that it is difficult to find strong policy justification to ban DTCA, and thus it would be difficult to provide a ¡¥demonstrable justification¡¦ in terms of the New Zealand Bill of Rights Act 1990
(e) Note that the Ministry¡¦s preferred policy option is to retain DTCA under more stringent rules and regulations than are currently in place, but continue industry self-regulation.
(f) Note that changes to the rules and regulations could include allowing DTCA in the media only; disallow pharmaceutical company sponsorship of events, increase fines for not complying with the legislation, specify the length of time that advertisements must show mandatory information; require voice-overs relaying risk information. The Ministry and Medsafe would need to undertake further consultation upon these options.
(g) (i) Agree that DTCA be banned; or
(ii) Agree that DTCA be retained under the current rules and regulations and industry self-regulation (status quo); or
(iii) Agree that DTCA be retained under more stringent rules and regulations, and industry self-regulation; or
(iv) Agree that DTCA be retained under more stringent rules and regulation and government regulation; or
(v) Agree that DTCA only be allowed as part of government approved public health campaigns.


David Lambie (Dr)
Deputy Director-General
Personal & Family Health Directorate

MINISTER¡¦S SIGNATURE:

DATE:

BACKGROUND INFORMATION
1. Direct-to-consumer advertising (DTCA) refers to medical advertising that is directed to the patient or consumer, as opposed to the medical practitioner or pharmacist. New Zealand and the United States of America are the only industrialised countries that allow DTCA, however many other countries are at present grappling with the issue of whether to permit DTCA.
2. DTCA has become commonplace in New Zealand in the last five years, with the introduction of extensive mass-media campaigns for drugs such as Xenical (weight loss), Flixotide (asthma), and Viagra (impotence).
3. The increased prevalence of DTCA has raised concerns about:
„h individual and public health
„h the appropriateness or inappropriateness of pharmaceutical use
„h the doctor/patient relationship
„h increasing health care costs ¡V to the individual and Government pharmaceutical budget.
4. In 2000 you directed the Ministry of Health to review the existing policy on direct-to-consumer advertising of pharmaceuticals and provide advice on whether there should be changes to the current regime, and if so, what these changes should be.
5. On 30 November 2000 the Ministry of Health released the ¡¥Direct-to-consumer Advertising of Prescription Medicines in New Zealand¡¦ discussion paper (the discussion paper) which reviewed the DTCA policy internationally and in New Zealand, and provided a range of policy options for the future. Forty-three submissions were received.
6. The polarised nature of the DTCA debate was exemplified in the submissions on the discussion paper, with an almost even split of submissions between those persuaded by the arguments in favour of DTCA and those persuaded by arguments against DTCA. The discussion paper asked respondents to identify which policy option they preferred. The resulting frequencies are reported in the following discussion, under each policy option.
Current regulatory environment for Direct to Consumer advertising of medicines
7. All advertisements must comply with the Medicines Act 1981 and the Medicines Regulations 1984, which provides, among other provisions, a range of restrictions on claims and a requirement for specific disclosure of side effects.
8. Other legislation covering prescription medicines advertising includes:
„h the Commerce Act 1986, which establishes the legal competitive environment within which prescription advertisers operate
„h the Fair Trading Act 1986, which legislates against unfair advertising
„h the Misuse of Drugs Act 1975, Consumer Guarantees Act 1994, Privacy Act 1993, and Health Information Privacy Code 1994. These also impact on how the pharmaceutical industry markets and sells prescription drugs.
9. In addition, the New Zealand Bill of Rights Act 1990 affirms the right to freedom of expression. This right protects the promotion of commercial products through advertising. Further comment is provided as to whether any attempt to restrict the provisions of the Medicines Act 1981 would be in breach of the Bill of Rights Act 1990 (See paragraph 32).
10. New Zealand¡¦s regulatory framework relies on compliance monitoring by Medsafe and industry self-regulation, with a fall back to judicial action in the case of non-compliance. In 1996 the Advertising Standards Authority introduced the Code of Therapeutic Advertising, which requires that advertisements not only comply with the relevant legislation, but also are also truthful, socially responsible and not misleading or deceptive.2 The Code applies to all forms of therapeutic advertising and covers prescription and non-prescription medicines, medical services, complementary medicines and food when a therapeutic purpose is claimed.
11. Since 1999 the Association of New Zealand Advertisers has provided a pre-vetting service to determine whether proposed advertisements complied with the legal and Code requirements. On 1 November 2000 this voluntary service was made mandatory by the advertising industry and renamed the Therapeutic Advertising Pre-Vetting Service (TAPS). All advertisements are vetted and issued with a TAPS number. The TAPS number provides an assurance to the broadcasting sector that the advertisement complies with the relevant legislation, regulations and industry Code of Practice.
COMMENT
Policy options
12. The ¡¥Direct to consumer advertising of Prescription Medicines in New Zealand¡¦ discussion paper sought submissions on four policy options for the regulatory environment for DTCA:
„h Ban DTCA
„h Retain DTCA under the current rules and regulations under the management of the industry (status quo)
„h Retain DTCA under more stringent rules and regulations than are presently in place, but continue with industry management of the process
„h Retain DTCA under more stringent rules and regulations than are presently in place, with management by a government agency.
13. A submission on the discussion paper also suggested that another policy option could be to ban DTCA, but allow government approved promotion of disease management education. This model could allow prescription drugs to be advertised to the public as part of a government run campaign.
14. Each of the policy options is assessed in the discussion below using the following criteria:
„h Ease of implementation
„h Fiscal implications
„h Evidence of harm or health improvements
„h Consumer access to information
„h Pragmatic considerations
„h Doctor/patient relationship
„h Legal implications.

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
(a) we have no evidence that the increases in physician visits or prescriptions are beneficial or harmful to consumers
(b) responsibility for prescribing lies with the physician

Evidence of harm or health improvements
22. 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
23. 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.
24. 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.
25. 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.
26. 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
27. 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.
28. 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.
Doctor/patient relationship
29. 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.
30. Research has also shown that a high proportion of doctors honour patient requests for advertised drugs.5
Legal issues
31. 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.
32. 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.
33. 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.
34. 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
35. 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.
36. 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
37. The status quo option would not require any legislative change, thus, no implementation would be required.
Fiscal implications
38. The status quo option would maintain the current economic activity and employment in the advertising industry.
39. 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
40. 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
41. 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
42. The status quo option would not change the current doctor/patient relationship.
Legal issues
43. 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
44. 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.
45. Some suggested changes to tighten DTCA legislation are:
„h 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 ¡V none of which are vetted by TAPS.
„h 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.
„h 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.
„h Fines for not complying with the legislation and regulations could be increased.
„h A Review of Regulation 8 of the Medicines Regulations 1984 to make it more sensible and practical to apply (see paragraph 51).
„h Specify the length of time for TV advertisements for the mandatory risk information to be specified, as well as the font size.
„h Require voice over of risk information (this is mandatory in the United States of America).
„h 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.
„h Require a fair balance of benefit and risk information (which is required in the United States of America).
Ease of implementation
46. 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
47. It is possible that legislative changes could lessen the pressure on the pharmaceuticals budget than the status quo option.
Access to information
48. Adopting the suggested changes to advertising regulations would enhance consumer access to accurate and balanced information.
Doctor/patient relationship
49. The option could put less pressure on the doctor/patient relationship.
Legal considerations and pragmatic considerations
50. 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.
51. 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.

Option 4: Allow DTCA under more stringent rules and regulations than are presently in place, but managed by government agency
52. This option involves a tightening of the regulatory regime (similar to but not necessarily the same as for Option 3) and a government agency taking control of overseeing industry compliance of the rules governing DTCA. Under this option it is likely that Medsafe¡¦s role would have to be expanded to include oversight of this regime.
Ease of implementation
53. This option would involve considerable Ministry personnel resource to both establish functions and to manage the vetting process of advertisements. This function would need to be absorbed by Medsafe although funding would still come from pharmaceutical companies.
54. This option would require an amendment to the Medicines Act 1981.
Access to information
55. Aside from a ban, this option would provide the strongest assurance that consumers were only subjected to accurate and balanced pharmaceutical information.
Pragmatic considerations
56. A government agency regulating pharmaceutical advertising would be seen to be entirely independent and transparent. However, a government agency would not have support from the pharmaceutical sector, which may in turn alter their compliance with the regulations.
Doctor/patient relationship
57. This option may reduce pressure on the doctor/patient relationship as consumers would not be exposed (and therefore not demand) as many pharmaceuticals as they do currently. Consumers may still obtain information from the internet, which may still lead them to request pharmaceuticals.
Fiscal implications
58. This option could involve significant cost to the Government ($1 to 2 million per year) if funded directly. Alternatively, these costs could be recovered if the agency was funded by fees paid by the pharmaceutical industry, just as they currently pay for advertisements to be vetted by TAPS.
Legal considerations
59. The same legal considerations apply as for Option 3.
Option 5: Only allow government approved DTCA
60. The Australian Government continues to ban DTCA of prescription medicines, however, it allows government sponsored public health campaigns, which do not mention specific pharmaceuticals.
61. This option would effectively be a ban. The arguments from option 1 are therefore applicable.
Review of regulatory environment governing DTCA for over-the-counter medicines or preparations (manufactured or natural)
62. The discussion paper asked respondents whether they considered there is a need for the Government to review the regulatory environment governing DTCA for over-the-counter medicines or preparations (manufactured or natural). Seventy percent of submissions supported the proposal. However, many submissions appeared to truncate the original question and agreed for the need to review the regulatory environment governing DTCA, without specifically acknowledging over-the-counter medicines. The Non-Prescription Medicines Association are concerned that a distinction be made between registered over-the counter medicines (medicines that have been through the Medsafe evaluation) and products available to consumers as dietary supplements or herbal remedies purporting to offer therapeutic benefits to consumers.
63. Many submissions that specifically addressed the discussion paper question, considered that sufficient regulation already exists for registered OTC medicines. The OTC medicines sector has to comply with the Medicines Act 1981 (and regulations), Medsafe Guidelines, and specific industry codes of practice. The Advertising Standards Authority Therapeutic Code covers all products that make a therapeutic claim whether they are prescription medicines or over-the counter medicines.
64. However, concern was expressed about natural and complementary medicines that technically evade the Medicines Regulations ie products on the fringes which ¡¥suggest¡¦ but do not make a therapeutic claim.
65. The Government has recently established an Advisory Committee on Complementary and Alternative Health to advise the Minister of Health on issues related to complementary and alternative healthcare products, therapies and practitioners. Given that this Committee has been established, it would not make sense for the Ministry to conduct a separate review on over-the counter medicines which have not been approved by Medsafe.
66. The proposal for a joint trans-Tasman agency to regulate therapeutic goods may precipitate the need to review the regulatory requirements for all medicines. Thus, it is recommended that the regulatory environment for over-the-counter medicines not be reviewed at present. However, this does not preclude any amendments to the Medicines Act 1981 or Regulations 1984 from also applying to over-the-counter medicines. Further, dietary supplements will be regulated under the planned trans-Tasman joint agency.
Treasury and Ministry of Justice comment
67. The Treasury and Ministry of Justice do not support any change to the current regulations covering DTCA practices as they believe there is no demonstrable justification for doing so. They consider that in order to address increases in visits to doctors and increases in prescribing, the Ministry of Health should focus on improving existing systems to better educate doctors about appropriate prescribing practice, especially in relation to new and emerging pharmaceuticals.
68. If there are issues around the nature of the content of advertisements (i.e. the advertisement contains claims that are false, misleading or deceptive), then this issue should be addressed by more stringent policing under the Fair Trading Act 1986.
69. Treasury and the Ministry of Justice consider that before any measure tightening the restrictions on DTCA can be considered a reasonable limitation on the right to freedom of expression, there would need to be some evidence demonstrating that the proposed measure provided the most minimal limitation on that right.
Ministry of Health preferred policy option
70. The policy debate surrounding DTCA is extremely contentious and highly political. It is difficult to formulate evidence-based policy as little empirical research exists. New Zealand is being watched by the international community to see which policy option we choose.
71. In summary, we can be sure that:
„h DTCA has been steadily increasing in New Zealand
„h Media advertising of prescription medicines is heavily concentrated among a relatively small number of drugs
„h DTCA stimulates sales of pharmaceuticals
„h Some studies have shown the quality of the information contained in advertisements is often poor
„h Physician visits increase for the conditions associated with advertised drugs increase during an advertising campaign, however, we cannot be sure on the appropriateness of these visits ie whether unmet need was met
„h A high proportion of physicians honour patient requests for advertised drugs
„h Responsibility for prescribing lies with the physician
„h Effects on the doctor/patient relationship remain largely unknown
„h No reliable evidence exists to support hypotheses of potential health benefits or potential harm resulting from DTCA
„h pharmaceutical advertising is an $18 million dollar industry in New Zealand
72. The Ministry of Health recommends allowing the continuation of direct to consumer advertising of prescription medicines, but with tighter regulations. Due to limited empirical evidence, it is difficult to find strong policy justification to ban DTCA as there is no proven link that DTCA directly harms consumers. Given this lack of policy justification, it would also be difficult to provide a ¡¥demonstrable justification¡¦ to ban DTCA in terms of the Human Rights Act 1990.
73. However, considering there is some evidence to show that DTCA contributes to increased doctor visits and prescriptions, it is recommended that the rules regulating DTCA should be strengthened to ensure that DTC advertisements provide balanced information. Hence the suggestion to require television and radio advertisements a voice-over of the risks. Further, the recommendation that DTCA only be permitted in the media, namely radio, television and print, would ensure that TAPS vets all DTC advertisements.
74. The regulations should also be reviewed to make sure that they are practical in terms of advertising technology. For example, both those in favour and against DTCA recommend reviewing Regulation 8 of the Medicines Regulation 1984.
75. The Ministry and Medsafe will need to be undertake further consultation to develop amendments to the Medicines Act 1981 and Medicines Regulations 1984. Alternatively, this work could also be considered as part of the development for the new legislation for the trans-Tasman joint therapeutics regulatory agency environment.
76. The Ministry agrees with the Ministry of Justice and Treasury that doctors have a responsibility to ensure that pharmaceuticals are prescribed appropriately. However, organisations already exist to provide prescribers with independent, evidence based advise to encourage appropriate prescribing, for example, the Preferred Medicines Centre Incorporated (PreMeC), the New Zealand Guidelines Group and Medsafe.
IMPLICATIONS FOR REDUCING INEQUALITIES
77. Concern has been expressed that DTCA targets the vulnerable (who may lack education or suffer from chronic or severe illness) with emotional rather than rational information. To ensure that consumers are empowered with accurate and balanced information, the Ministry preferred option is to permit DTCA but tighten the regulations.

ENDS

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