Three stories from Canada have caught our attention this week, all around legalities and regulations regarding medicines in the country.
Pharma Abuse Of Dominance Investigation discontinued
An investigation launched back in 2016 to investigate the alleged abuse of dominant positions in the market by brands including including Celgene, Pfizer and Sanofi-Aventis. The Competition Bureau have determined that there is currently insufficient evidence to pursue the investigation any further at this time. However, they have left open the possibility of returning to the case in future.
Specifically, this investigation looked into whether the manufacturers were causing other companies unnecessary difficulties in obtaining samples of their products. This action would have prevented the production of generic versions of their products entering the market, thus protecting the market share enjoyed by the original products.
Genetic Non-Discrimination Act struck down by Québec Court Of Appeal
The Genetic Non-Discrimination Act came into law in May 2017, but was challenged on the grounds that it was unconstitutional (being that it refers to civil or property aspects of law rather than criminal). The Government of Québec referred the question of constitutionality to the Québec Court of Appeal, and the case was heard in December 2018.
The Court agreed with the grounds given above, and ruled to strike down the law.
However, the Act was intended to protect against citizens being discriminated for products such as health insurance when genetic tests revealed a probability of contracting a disease, for example. The Canadian Coalition for Genetic Fairness has filed an appeal which will be heard at the Supreme Court.
Notifying Health Canada of foreign actions: Guidance updated
The provisions contained within the 2018 Food and Drug Regulations around foreign risk reporting came into force in October, triggering an update to the Health Canada publication Notifying Health Canada of Foreign Actions – Guidance Document for Industry.