Apr 15, 2022 | International
Statement
Today, our government announced that it will proceed with Amendments to the Patented Medicines Regulations to provide the Patented Medicine Prices Review Board (PMPRB) with new tools to protect Canadians from excessive prices for patented medicines.
April 14, 2022 | Ottawa, ON | Health Canada
Today, the Honourable Jean-Yves Duclos, Minister of Health, issued the following statement:
The Government of Canada is committed to improving access to quality medicines for Canadians. Today, our government announced that it will proceed with Amendments to the Patented Medicines Regulations to provide the Patented Medicine Prices Review Board (PMPRB) with new tools to protect Canadians from excessive prices for patented medicines.
This will improve access for Canadians to quality medicines while generating significant savings over the coming years. At the same time, these changes will ensure the sustainability of the healthcare system, while supporting innovation and investment in the pharmaceutical sector.
After consulting with stakeholders on a way forward in March 2022, Health Canada will be moving forward with the implementation of the new basket of comparator countries and reduced reporting requirements for those medicines at lowest risk of excessive pricing. These Amendments will come-into-force on July 1, 2022.
The Government will not proceed with the Amendments related to the new price regulatory factors, nor with the requirements to file information net of all price adjustments. This will be reflected in Canada Gazette in late Spring 2022.
The Amendments, originally proposed in 2019, were the first substantive update to the regulations in more than 30 years. Since then, the pharmaceutical landscape has shifted dramatically, a new context has developed brought on by the COVID-19 pandemic, coupled with the progression of various initiatives seeking to improve accessibility and affordability for needed medicines.
In addition to these regulatory changes, the Government continues its work to streamline the approval of new drugs, advance on universal national pharmacare, develop a national strategy for drugs for rare diseases, and proceed with an ambitious biomanufacturing and life sciences strategy.
Contacts
Marie-France Proulx
Press Secretary
Office of Honourable Jean-Yves Duclos
Minister of Health
613-957-0200
Media Relations
Health Canada
613-957-2983
media@hc-sc.gc.ca
Jan 1, 2022 | International
FEHD strengthens regulations on handling of meat and poultry by fresh provision shops
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With a view to ensuring food safety and enhancing environmental hygiene, a spokesman for the Food and Environmental Hygiene Department (FEHD) said today (December 31) that the FEHD will introduce a new licensing condition in fresh provision shops (FPS) licences to strengthen the regulations on their handling of meat and poultry.
The spokesman said, “The new licensing condition stipulates that unless prior written approval for an alternative arrangement has been obtained from the FEHD, all fresh/chilled/frozen meat or poultry to be delivered to the licensed FPS for sale, no matter whether the meat or poultry is prepackaged, must be directly delivered into the premises, and at no time be left or kept outside the premises (including any street, pavement, alley, passageway, and space) pending further handling or sale. In addition, in any circumstances under the alternative arrangement, the meat or poultry must at all times be properly kept in a clean and hygienic condition and be so protected to prevent from the invasion or contamination by any kind of animals (including mammals, birds and insects) or the ambient environment pending collection or during delivery into the premises.”
“Under the new arrangement, the FEHD will impose the above licensing condition in newly issued FPS licences starting January next year. If the applicants consider it necessary, they are required to apply to FEHD for prior approval for alternative arrangement when they apply for the licences.”
For existing FPSs with valid licences, the FEHD has met with various trade representatives recently to explain the operation details of the new licensing condition and gauge their views, and will also issue letters to serve as a notice to existing licensees of all FPSs. The above licensing condition will be added to the renewed licences, and a notification period of at least 90 days are given before the new condition comes into effect. Applications for alternative arrangement shall be made at least one month before the expiry of the existing licences. The FEHD appealed to licensees of all FPSs to make preparation and follow up as early as possible.
“When considering the approval of alternative arrangement for newly issued licences or renewed licences, the FEHD will take into account if the FPSs have practical difficulties that render direct delivery of meat or poultry into the premises impossible. If licensed FPSs are found in breach of the abovementioned licensing condition, the FEHD will consider cancelling their licences,” the spokesman added.
The spokesman said that the FEHD will evaluate the effectiveness of the initiative after implementation, and will step up inspections and enforcement actions as necessary to ensure that FPSs comply with the relevant licensing condition as well as various regulations stipulated under the Food Business Regulation (Cap. 132X) and other relevant laws. He appealed to all FPS practitioners and the trade to work together with the Government to safeguard food safety and protect public health.
