OTC in Action Episode 1


OTC medications are gaining respect worldwide. They offer convenient, safe and effective treatment at low, or no, cost to consumers and other healthcare payers, including health insurance plans and governments. Our new OTCs in Action column will share the good news about how OTCs around the world are finally getting the respect they deserve.

Harmonisation: OTCs gain respect in North America

Nicholas Hall & Company’s OTC.NewDirections bulletin reports that the US-Canada Regulatory Cooperation Council’s Joint Forward Plan calls for the FDA and Health Canada to co-ordinate and adjust their respective OTC monograph development processes to reduce regulatory burdens on stakeholders (and themselves) [link]. The fact that OTCs are part of the plan validates their importance. Given the commonality of brands / marketers across both markets, this harmonisation is a real benefit to manufacturers. That said, OTC INSIGHT North America reported last spring on the FDA’s public hearing to explore ways to update its inefficient OTC monograph [link]. Perhaps the US can sync with Canada to fast-forward its process.

Canada has been modernising its OTC regulatory structure. Last year, Health Canada combined the Nonprescription Drug and Natural Health Product programmes to form the the Natural Health Products Directorate (NHPD), establishing a single department to align oversight of all consumer health products. This important initiative was improved further this summer when the agency added “nonprescription” to the department’s name, now the Natural & Nonprescription Health Products Directorate (NNHPD). On a more substantive note, Health Canada is also making progress with product licensing applications, labelling requirements and Rx-to-OTC switch guidelines.

OTC INSIGHT North America also reported last month on another Canada-US harmonisation initiative: “This autumn, it is expected that Canada’s federal government will set out its plans to implement a budget commitment to investigate, and possibly control, higher prices on consumer goods in Canada relative to the US market. The media has already pointed out some of the differences in the consumer health product market when the Conservative Government launched its “consumer first” agenda over a year ago and some OTC products were included in the ensuing media dust-up.”

Where OTC products are concerned, Canadian distribution laws actually can result in higher costs. However, these subtleties have been lost in the blame game for high prices between retailers and manufacturers. As the report says: “It seems more likely that this is a chicken and egg scenario that will play out with each part of the supply chain defending their costs, possibly suggesting that one of the other players in the system should take the hit on any actions to roll prices closer to the US norm.”

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