Efforts by Health Canada to harmonise standards for prescription drugs have, so far, been putting private profit ahead of public health, claims a new study.
The agency has been “deliberately ignoring” harmonisation efforts that would raise standards while working with the drug industry to lower drug safety standards and speed new drugs to market, according to the report, which is published by the Canadian Centre for Policy Alternatives (CCPA) as Health Canada begins its final consultations on proposals to modernise standards for prescription drugs.
The report acknowledges that harmonising drug regulation standards among countries makes sense since it can reduce the workload on individual regulatory agencies and allow them to draw on each other’s strengths. However, it adds, the main driving force in the field is the International Conference on Harmonization (ICH), an organization whose only voting members are the regulatory agencies and associations representing the brand-name pharmaceutical industry in the European Union (EU), Japan and the US.
The pharmaceutical industry’s main goal in participating in the ICH is to get its products to market more rapidly and at less cost, and while regulatory agencies justify participation on the grounds that the ICH will lead to newer and better medicines, in fact only a small fraction of new drugs that are marketed are major therapeutic advances, it adds.
Moreover, “research indicates that, when it comes to safety, ICH has been harmonising to the lowest common denominator,” the study claims.
Health Canada sits as an observer at ICH meetings and sees its involvement as crucial - but makes very little information about its role available on its website - but a 1999 document made it clear that the agency saw pursuing international agreements as a priority, says the study.
It points to Health Canada’s moves to shorten the time taken to approve the early phase of clinical trials as “an early example of harmonisation and how industry’s goals seemed to have been prioritised.” The initial discussion paper put out by the agency on this topic was “deficient in a number of areas” and emphasised how the changes would increase industry investment in Canada, it says, adding that, since then, Health Canada has gone on to sign agreements to share information, on a confidential basis, with Australia, the EU and the US.
Harmonisation is also intimately tied in with the federal government’s policy of “smart” regulation, whose messages - making sure that Canadian standards conform with those of its major trading partners and speeding up the drug regulatory process - are also messages that coincide with the priorities of the pharmaceutical industry. While faster approvals get drugs to market more quickly, they may also compromise safety - an important consideration as an increasing number of people are exposed to new drugs that ultimately are pulled from the market because of safety concerns, the study warns.
Although Health Canada has harmonised some aspects of drug regulation, it has ignored others, the study goes on. For example, the agency has explicitly rejected developing standards for the length of time it takes between receiving a report of an adverse drug reaction (ADR) and when that report has been analysed and posted on its website. Also, while Health Canada has been talking for five years about requiring the public registration of clinical trials it has not yet taken any action, nor is there any timeline for a decision.
“The evidence to date suggests that we have been harmonising down,” says study author Joel Lexchin, a professor at York University’s school of health policy and management. “Regulatory harmonisation needs to be undertaken in the interests of public health, not private profit. To date, that has not been happening,” he adds.
