Drug regulator must put patient safety ahead of Big Pharma profits

Overseas drug approval may have unintended consequences. Victor/Flickr, CC BY

One of the much-heralded platforms of the Abbott government is its promise to business to reduce red tape and burdensome regulatory obligations. Pharmaceuticals are a multi-billion dollar global industry, so it’s not surprising the national drug and device regulator, the Therapeutic Goods Administration (TGA), is a key target.

A committee tasked with investigating the options for red tape reform has released its first discussion paper to canvass the options.

The paper raises some important implementation problems and potential reforms. But we need to be wary of commercial interests derailing drug approval and advertising regulations that protect patient safety and ensure products are evidence-based.

Local drug approval

The discussion paper sets out the laudable, commonsense idea that:

if a system, service or product has been approved under a trusted international standard or risk assessment, Australian regulators should not impose any additional requirements unless it can be demonstrated that there is good reason to do so.

The concept here is that the duplication of regulatory paperwork involved in introducing a new medication for sale in Australia could be prevented if we identified some other national regulatory agencies whose standards we would effectively accept as equivalent to ours.

If a drug was approved by the United States Food and Drug Administration (FDA), for example, the TGA would automatically accept it here as well for the same purpose. The savings in time and money to drug manufacturers would be considerable, as it would reduce the expense of listing new drugs in this country.

Some red tape is important for consumer protection. Shutterstock

But this simple idea could play out in a number of undesirable ways.

If “trusted regulators” disagreed with each other about the safety or efficacy of a drug, the TGA would have to choose one over the other, or insist on a separate application. This would either weaken the status of a “trusted” regulator or defeat the purpose of the proposed change.

A drug formulation with existing approval could be changed overseas, with ingredients added or subtracted. We might be in a situation where an ingredient discouraged or banned in Australia might be able to be forced onto the market by an automatic inclusion agreement.

We don’t really know whether reducing this red tape will improve or hinder the TGA’s ability to regulate the safety of drugs sold in Australia. We might be flooded with overseas-approved drugs with few advantages over our current ones. Maybe there’s a case for forcing the pharmaceutical companies to only bet on drugs that are proven winners.

Overall, it’s unclear whether the end result would mean any net benefit to consumers and the TGA, whereas the benefits to industry are obvious.


Pharmaceutical companies want the TGA to ease the requirement to prove their over-the-counter, pharmacy-only drugs do what they say on the label.

The report notes:

only ten ingredients are currently included in Appendix H, which industry stakeholders argue is due to the resource costs involved with satisfying evidentiary requirements.

In practice, this limits the number of over-the-counter (Schedule 3 products companies can sell in pharmacies without a prescription. The companies say this is because it’s too expensive for them to do the scientific studies required to show evidence of efficacy and safety to add to this number.

The current list has been essentially “grandfathered” in, based on ingredients that have been used for some time, without significant safety concerns. Companies have been making solid money from these ten ingredients for decades without having to put up good evidence of benefit.

Good medicine requires good information. Ben W/Flickr, CC BY-NC

A 2012 Cochrane review, for instance, concluded that over-the-counter cough medicines have no good evidence either for or against their use due to the age and poor methodology of the studies they reviewed. The same conclusion was reached years earlier and no new evidence had been produced despite the supposed urgent need for such studies.

In the absence of solid science to support claims of benefit, manufacturers should not be further disencumbered of the few obligations they have to demonstrate that their product actually does what they claim in the advertising.

Advertising pharmaceuticals

Slightly more worrying is the consideration to allow direct-to-consumer advertising for prescription-only (Schedule 4) medicines. New Zealand and the United States are currently the only countries that permit advertising prescription medicines to consumers.

The blatant undermining of health professionals is sold as “patient empowerment”. But I haven’t seen any evidence that flooding TV, internet and radio with pharmaceutical ads can further the consumer’s interests without intruding on the professional relationship they have with their GP or specialist.

Under the Australian model, a doctor with expertise in a specific field recommends a treatment, which the patient can then research and decide about.

Penalties for breaches

Finally, the Review rightly identifies that strong public interest in the lack of enforcement of advertising breaches highlights the perception of the TGA as a paper tiger. It notes that:

the low penalty levels may make mounting a successful prosecution for an advertising breach difficult, as the breach would be assessed by the Commonwealth Director of Public Prosecutions (CDPP) as a trivial offence under the CDPP’s prosecution policy and guidelines.

Misleading consumers about health-care products should not be shrugged off as “trivial”. The TGA needs to be given adequate legislative power and administrative resources to ensure there is a credible deterrent for companies who want to take short cuts in their evidence or quality procedures, or exaggerate the benefits of their products.

The available track record of TGA prosecutions suggests the industry does not fear compliance penalties when their big-money product lines are threatened.

Maintaining high standards

There may be some areas where streamlining procedural red tape benefits consumers. There could even be some savings to Medicare or the PBS, though this is up for debate. But no matter how much companies may whine about regulation, we should never lower the bar for the protection of health consumers.

Besides, you can still make substantial profits by fairly and ethically selling medicines.

Good medicine depends on clinicians making accurate judgements about risk and benefit, and advising patients so they can make the best decision for them about their medicines. Exaggerating or misrepresenting the benefits and concealing or under-reporting the harms distort this judgement and undermine good practice.

We should never apologise for defending the highest possible standards for safety and efficacy in regulating the health care business. If that means keeping some red tape, I’ll tie the bow myself.