Consultations Commence for Major Changes to Canadian Pharmaceutical Policy
On May 16, 2017, the Federal Minister of Health, the Hon. Jane Philpott presented several major announcements, which are likely to have significant impacts on both national and provincial/territorial pharmaceutical policy. The announcements covered an array of developments including:
- changes to the regulations that govern how the Patented Medicine Prices Review Board (PMPRB) operates;
- enhancing the capacity of the pan-Canadian Pharmaceutical Alliance (pCPA) which will be further elucidated in an upcoming announcement;
- closer alignment of drug submission review activities between Health Canada and the Canadian Agency for Drugs and Technologies in Health (CADTH);
- expansion to Health Canada’s priority review policy;
- a National Formulary to make access more equitable between payers; and
- expanding the availability of prescribing data through initiatives related to Canada Health Infoway E-Prescribing System.
According to the Minister, this announcement represents the most significant suite of changes to impact pharmaceutical pricing proposed in over two decades. Please see the summary below for more information on the Minister’s comments.
The key regulatory changes focus on elements such as:
- Reference Countries – to update the list of reference countries to one that is “better aligned with Canada economically (for example) and also countries that have effective cost containment measures to protect consumers.”
- “Me Too Drugs” – the Minister believes value for money should be a factor that is considered – “we have to see evidence that the drug will prolong life and/or improve the quality of life.”
- Drug Price Reporting – since confidential price rebates are not currently factored in by the PMPRB, the Minister is proposing “a requirement to report rebates, discounts, and refunds to payers.”
Timing of Regulatory Changes
- May 16, 2017 – Launch of Public Consultations
- June 28, 2017 – Conclusion of Public Consultations
- Fall 2017 – Publication of Draft Regulations Posted in Canada Gazette Part I for Consultation
- By End of 2018 – Final Regulations implemented by Health Canada
Further information on Health Canada’s PMPRB Consultations can be found here:
Protecting Canadians from Excessive Drug Prices Consulting on Proposed Amendments to the Patented Medicines Regulations
Enhancing pCPA Capacity
- Working with provincial and territorial jurisdictions to enhance the capacity of the pCPA with an announcement anticipated in the coming weeks.
CADTH & Health Canada
- Align process between Health Canada and CADTH and, if possible, move towards concurrent reviews.
- Currently pilot testing the combined process with CADTH.
- Will provide guidance to drug sponsors early in the process to help them meet the needs for both Health Canada and CADTH when they are submitting their application.
- Both Health Canada and CADTH plan to increase the use of Real World data throughout the product life cycle
Expansion of its priority review policy: while the current policy grants a shorter review period for drugs for diseases where there is currently no treatment, the Minister is proposing broadening that to apply to other new drugs which may meet special needs of the healthcare system and patients
- The Minister noted that Canada has numerous public and private drug plans with various formularies.
- She indicated that the development of a National Formulary is an essential building block to improve equitable access and may “also improve our ability to negotiate better prices for Canadians.”
- Minister Philpott has raised this topic to provincial and territorial colleagues to positive feedback and she intends to continue to raise this issue in upcoming Health Ministers’ meetings.
- She noted that there are options to consider such as starting with a small list of essential medicines (including the majority of drugs in common use), or focusing on joint decisions to list new drugs as they enter the market.
Expanding the Availability of Prescribing Data
- In addition to the work of the Canadian Institute for Health Information (CIHI), Canada Health Infoway’s E-Prescribing System will play a role in expanding the data available.
- The Minister noted that once complete, this new drug information system is going to be a comprehensive system helping to improve the safe use of prescription drugs for Canadians.
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