NZORD submission to the Ministry of Health on Direct-to-Consumer Advertising of Prescription Medicines
In March 2006 the Ministry of Health called for public submissions on DTCA. Changes to advertising rules will occur because of the proposed Australia-New Zealand Therapeutic Goods Administration, and while advising the extent of the proposed changes, the Ministry took the opportunity to consult because of perceived concerns about DTCA in New Zealand. Click on this link for the discussion document on the Ministry's website. Here is the submission made by NZORD.
NZORD is a Charitable Trust that works to improve information, clinical care and research into rare disorders, and works in collaboration with health professionals and policy agencies to achieve these outcomes. We operate as an umbrella network for more than 120 rare disease support groups and in addition we have good links and collaboration with many of the 70+ groups dealing with more common disorders. We cannot assume to fully represent their views, but can claim to be well connected with the issues and challenges they face, and in touch with many of their views and concerns.
Over the past five years we have consulted widely with many groups on many topics, and submitted on a wide range of Ministry consultations and on those of other agencies, e.g. Pharmac, Food Safety Authority, Bioethics council, etc. We have usually felt quite confident in the stance we have taken in those submissions, even allowing for the diversity of views and attitudes among groups and their leaders, because of wide discussion within our networks on the topics on many occasions, and the relative ease of identifying a position that is likely to reflect the mainstream of opinion and interests among the variety of groups.
On this occasion we feel obliged to say that a consensus position would be much more difficult to identify. Some reasons for this are:
- Much less effort at wider discussion or consultation on this specific topic as it has not seemed to be a priority issue for many groups - despite indications in your discussion document that it is a matter of concern in the community.
- A sense that many opinions expressed on this topic within the wider community (for or against) often seem to be driven by agendas or political perspectives rather than by objective assessment of evidence.
- A significant change in the dynamics of health information availability via the internet in the past decade, and the significant impact this may have on doctor/patient relationships (whether influenced by DTCA or not), in circumstances where these changes have not been easily adjusted to by some professionals.
Therefore what we submit is a series of “middle ground” observations gleaned from discussions with no more than a few dozen support group leaders in personal conversation or in health policy meetings in recent years. We hope you find these relevant to the discussion and useful to you in formulating your advice to government.
Our observations are:
- We accept the need for regulation of prescription medicines because of the basic principle that such medicines will invariably have some side-effects and contra-indications that need careful evaluation and consideration, as well as licensing of who can prescribe them. That is the same basic premise that justifies at least some controls and regulation of information/advertising of them also.
- However we are surprised that so much discussion and energy goes into the question of regulating advertising of prescription medicines, yet so little into the same issues relating to over the counter medicines (OTC), or even complementary or alternative medicines (CAM). Those other medicines can be harmful in the wrong dose or in the wrong combinations. There seems to be a strong case for consistency of approach across all medicines, rather than a specific focus on one class.
- Although your consultation is about prescription medicines only, we think the approach taken towards them should be adopted in principle for all medicines and your advice to government should not exclude advice on advertising of OTC or CAM. In our experience there are as many concerns expressed about inappropriate claims for and promotion of these items, as there are expressed about advertising of prescription medicines. There are also significant concerns about CAM enthusiasts advising against prescribed medicine use.
- In your paper you refer to the 1998 inquiry into DTCA and disquiet from health professionals about its impact. We would suggest the timing of that survey might have significance in coinciding with major internet growth and a significantly better informed community. We don’t think the appropriate response to patient demand (even if inappropriate demand) is to block out the information. Education and the development of a more sophisticated community is a much better approach than censorship.
- If the presence of information about prescription medicines was presumed to be harmful because it led to inappropriate patient demand, then the government should cancel its subscription to the BMJ Best Treatments website, or restrict access to the site so only health professionals could access it, for on that site there is substantial information about treatments that are invariably prescription only, that are freely viewable to all patients with an internet connection. The impracticality of this approach is obvious.
- It should be important for your advice to government to note that they are not a neutral party in this debate. Because they pay subsidy on most prescription medicines they also have a direct financial interest in the debate. Government should be encouraged to take the highest principled position of public good regulator and avoid any temptation to make decisions that may be weighted to its own financial interest. This is particularly so in circumstances where many pharmaceuticals are subject to delay in government subsidy, and the subsidy is a key factor in patient access to the drug. There could be a very strong temptation for government to effectively suppress information about drugs that do meet best practice but which it does not fund.
- If government is to use objective financial factors in the decision making process on prescription medicines it should also apply those same factors consistently across OTC and CAM, for there are very significant sums spent in those two areas each year in New Zealand.
- Some of the argument against DTCA, such as medicalisation of normal processes and influencing patient behaviour, are regarded by some as patronising and disempowering by some individuals, just as they are adopted with enthusiasm by others.
Summarising these observations into direct response to the questions in the discussion document:
Q1. There are some concerns that DTCA could have some negative consequences but on balance most views regard it in a neutral light and would support regulation only to the minimum level needed for safety, accuracy, patient protection, etc.
Q2. The interest shown by most groups/individuals revolves around access to good quality information about treatments for their health condition. There is a preference for open access to information that meets a good standard of accuracy and presentation.
Q3. The case for DTCA seems most sustainable, provided the quality of information assists good decisions and empowers people in managing their health care. Suppression of information seems draconian as well as impracticable. The precautionary principle does not seem to be a sound basis for decision making on DTCA. There should be a much higher threshold of evidence required to justify any interference in information flow.
Q4. Encourage a balanced assessment of DTCA against OTC and CAM advertising, and the application of a consistent approach across all types of medicine advertising.
Q5. On the basis of our observations above, and the very limited evidence to support stronger controls, we would support the default position, Option 1, envisaged by the Therapeutic Products Advertising Code.
Q6. We do not support any further options for DTCA regulation.
Q7. While there is now a wealth of publicly available health information on the internet, there is great potential for this to be improved considerably by provision of New Zealand focused websites that draw together a lot of relevant links and information sources to provide a high quality internet reference site for New Zealand patients. MedlinePlus is a good example of this being very well done in the United States. There are not many New Zealand sites at all that do this sort of thing well enough for the New Zealand community. In fact some that attempt to do this, including some that are government funded, do it badly.