Quebec Bill 81; Tender process for drugs and distribution – Draft regulation

The proposed regulation around Bill 81 was published recently in the Official Gazette of Quebec. Two components of this legislation was adopted by the Quebec National Assembly on June 9th of this year.

The followings are highlights for consideration at this time.

The Health Minister could be using two different forms of tenders for drugs.

The first one is a more traditional one where manufacturers are invited to bid. The Health Minister may decide to adjudicate the contract to include up to 3 manufacturers. Each manufacturer will be assigned a market share. The mechanics of how this will work are not detailed in the draft regulations. This form of market share allocation could be challenging in many ways, in terms of implementation.

The second type of tender is a fixed-price tender. In this case, the Health Minister will determine the price of the drug. The award will be granted to all eligible manufacturers whose tender is compliant. If such competition is insufficient, the Health Minister may open the tender to outside suppliers.

As for the wholesaler part, the proposed regulation does not offer any details other than the admissibility condition to bid on a tender. The process for tendering for exclusive distribution by one (or maybe more than one) wholesaler is not finalized at this time.

Stakeholders interested in commenting on this regulation have 45 days to submit their opinions or suggestions. There should be more information on the final regulation later this fall, possibly in November.

For more information, please do not hesitate to contact Ghislain Gauthier, Director, The Pangaea Group