Ottawa, Ontario–(Newsfile Corp. – June 23, 2021) – On June 21, Innovative Medicines Canada (IMC) submitted six recommendations to the federal government as part of the Patented Medicine Prices Review Board’s (PMPRB) Guideline Monitoring and Evaluation Plan consultations. IMC firmly maintains that industry is prepared to consult and collaborate with governments with a view to protecting the health of Canadians.
Regulatory amendments to the Patented Medicine Prices Review Board (PMPRB), Canada’s drug pricing ceiling regulator are set to be implemented on July 1. These severe changes will impede R&D investment in Canada’s biopharmaceutical sector and reduce access to new medicines for Canadians. PMPRB’s reforms have prompted concern.
Ahead of the planned implementation of these reforms, the PMPRB is proposing a Guideline Monitoring and Evaluation Plan (GMEP) to assess the impact of its amendments. IMC contends that it is premature to implement an evaluation framework when there is still a marked need for PMPRB to consult with its stakeholders on its approach to reforms.
IMC stands with provinces, patient groups, and life sciences stakeholders in calling on the federal government to stop the implementation of the PMPRB regulations on July 1, and to undertake in-depth consultations with stakeholders on its regulatory amendments.
IMC’s GMEP submission proposes the following recommendations:
- Prioritize resources to address COVID-19 and stop the PMPRB regulatory reforms given the ongoing pandemic.
- Given the impact of two judicial decisions, PMPRB needs to reconsider and revise its final Guidelines.
- Ensure that the impact of the PMPRB changes is assessed by an independent third party.
- Concentrate on reporting metrics within the PMPRB’s mandate.
- Limit PMPRB reporting data resources to regulatory filing information only.
- Replace or supplement the PMPRB’s outdated 1987 definition of industry R&D with the more credible alternative recently used by Statistics Canada.
IMC also calls on the federal government to join in a roundtable discussion about the path forward to an actionable national life sciences strategy. Such a strategy must address such critical issues as domestic manufacturing, a more streamlined review process, and a more balanced and predictable price regulatory system. This can be accomplished while addressing affordability and pharmaceutical system sustainability considerations.
Our industry stands ready to collaborate with governments on changes to the PMPRB that will be less damaging to Canada’s domestic life sciences capacity and timely access to medicines and vaccines for all Canadians.
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Innovative Medicines Canada is the national association representing the voice of Canada’s innovative pharmaceutical industry. The association advocates for policies that enable the discovery, development, and delivery of innovative medicines and vaccines to improve the lives of all Canadians and supports the members’ commitment to being a valued partner in the Canadian healthcare system. The association represents 47 companies who invest nearly $1.2-billion in R&D annually, fueling Canada’s knowledge-based economy, while contributing $8-billion to Canada’s economy. Guided by the Code of Ethical Practices, all members work with governments, private payers, healthcare professionals, and stakeholders in a highly ethical manner.
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