The Parliamentary Secretary for Health, Mark Butler, is coming under pressure over a meeting scheduled between the Therapeutics Goods Administration and industry, which he mentioned in this release.
Dr Ken Harvey, a tireless campaigner for ethical marketing, outlined his concerns about the bilateral meeting in this recent Croakey post.
Now, Health Action International, “an independent, global network, working to increase access to essential medicines and improve their rational use through research excellence and evidence-based advocacy”, has written to the Minister, raising similar concerns and calling for more effective regulation of marketing.
Here’s the letter:
10 September 2009
Sustaining a strong national medicines policy in Australia calls for a committed partnership between all of the stakeholders affected by the policy’s content. For this reason, Health Action International (HAI) is deeply concerned to learn that the country’s Therapeutics Goods Administration (TGA) plans to meet with various industry associations later this month to discuss their various codes of conduct and determine potential strategies for a way forward.
Such a bilateral approach to controlling pharmaceutical promotion—without expert input from civil society and health care professionals or any reference to the World Health Organization’s Ethical Criteria on the Promotion of Medicinal Products —does little to earn or retain public trust in the Australian government’s efforts to protect public health. Instead, it seems aimed at accommodating the industry’s need to create markets for its products.
As an organisation devoted to the rational use of medicines, we know that the evidence shows that self regulation of promotion by the pharmaceutical industry has been mostly ineffective. This is mainly due to the obvious conflict of interest between the business goals of pharmaceutical manufacturers and the need to protect public health and ensure that medicines are used in a acceptably safe and rational way. Promotion is a key factor driving sales. When product sales are given priority over public health, promotion can lead to over-prescribing and poor quality prescribing and medicine use. This, in turn, leads to an increased risk of adverse effects and higher health care costs. Unethical pharmaceutical promotion has led to numerous health disasters, including those caused by thalidomide, DES and more recently, rofecoxib (Vioxx).
Codes of conduct, developed by industry associations or related groups, lack the strength of legislation and usually contain few or no provisions on enforcement and substantial sanctions. In addition, your belief that removing code inconsistencies and adopting a national, industry-wide approach will push companies to follow the highest possible ethical standards may instead result in the adoption of code provisions of the lowest common denominator.
Instead, HAI and a number of its public health contacts in Australia believe that a new approach to pharmaceutical regulation on promotion is required. There should be one code applicable to all therapeutic claims and promotional practices; one complaint (and appeal) process, one monitoring process and one set of effective sanctions, including corrective advertising orders and fines related to the sales income of the product and company involved.
Unlike your proposal, we believe this process should be overseen by government, funded by industry (through product registration fees), and carried out by an independent committee representative of all stakeholders. The system should have a legislative base in the TGA and/or regulations and have strong enforcement provisions. Such a new system would be in line with the 2007 World Health Assembly Resolution WHA 60.16.5 on the Rational Use of Medicines. This urged member states (including Australia) to:
“Enact new, or enforce existing, legislation to ban inaccurate, misleading or unethical promotion of medicines, to monitor promotion of medicines, and to develop and implement programmes that will provide independent, non-promotional information about medicines”.
Ensuring the rational use of medicines is too important a task to be left to the industry alone. For years, Australia’s Medicines Policy has been a model to countries in the Asia Pacific region. Allowing just the industry to advise the government on the best way to control inappropriate and unethical promotion goes against the spirit of the national policy and damages its independent, public health approach. Instead of encouraging the country’s pharmaceutial industry to determine how its products can be marketed, Australia should make regulation of pharmaceutical promotion a higher priority. HAI urges the Australian government to take the lead in formulating
effective regulatory policies that enable companies to sell needed medicines and demand that they market them in a responsible way.
Dr. Tim Reed