The Government of Canada's recent announcement to provide provinces with $1.5 billion in funding over three years represents an important opportunity to better support Canadians living with rare disease.Pfizer joins the rare disease community in thanking the Government of Canada for this needed investment in rare disease care. The federal Minister of Health articulated the need for improved access to medications and further allocation of additional funding for First Nations and Inuit patients living with rare diseases. With 95% of rare diseases having no available treatments, Minister Duclos also announced investments in clinical trial networks, screening and diagnostic tools. Through this plan, the community will have a seat at the table with the establishment of an Advisory Group.Rooted in this plan is the acknowledgement that scientific knowledge and ability to conceive and develop new treatments continue to grow at an astonishing pace – and our regulatory and health care models must keep up. With its commitment, Canada is joining a growing number of countries who are focused on modernizing their health systems to better care for and support people living with rare disease.By leveraging global insights alongside the new capabilities and resources provided with this funding, we can action a national strategy for rare disease that truly meets the needs of the rare disease community.This plan is a significant step forward and can be further strengthened through additional elements. Canada should start by adopting a formal definition of rare disease that is consistent with international standards such as the European Union (equivalent to less than 1 in 2,000 people). Why would this be helpful? The adoption of a common definition would create the necessary pathways for Health Canada, the Canadian Agency for Drugs & Technologies in Health (CADTH), the Institut national d'excellence en santé et en services sociaux (INESSS), and provincial and territorial drug payers to streamline and accelerate access to current and emerging treatments and innovations – aligning with the Minister's goals. It would also represent a 'guiding star' for key partners such as patients and patient associations, pharmaceutical manufacturers, and government decision-makers and provide a way to measure success; which key stakeholders at the Canadian Organization for Rare Disorders (CORD) Conference referred to during the week of March 27th 2023.Leveraging global learnings and applying them to our Canadian landscape will have a very positive impact on patient outcomes.In France, we have seen the benefits of its early access program, or 'autorisation temporaire d'utilisation' (ATU). The program was implemented to provide a clear process that enables access to certain treatments where there is a high unmet need ahead of pricing negotiations, market permission or reimbursement. Through the program, 82% of non-COVID-related applications have been accepted by Haute Autorité Santé (HAS). Almost 70% of drugs have been made available in France before US FDA approval, meaning improved access to innovative therapies for those who urgently need them.Continued federal, provincial and stakeholder collaboration will be essential as the provinces and territories develop their approaches and work out the details of the pending bilateral agreements.While Canada's primarily provincial-led system and countries in the EU with national-based systems make it difficult to propose an apples-to-apples comparison, there are important lessons to be learned from the regional collaboration and information-sharing of European countries' efforts, as well as ongoing evolution to reflect changing needs.Looking to European countries for additional lessons learned that Canada, as well as the provinces and territories could consider leveraging and adapting, these examples all support earlier access for patients and negotiations with payers around mutual value. It also demonstrates that a new way of doing things can be achieved - again the Canadian way. Such practices include early access programs with specific criteria before regulatory approval is granted; providing patients access immediately upon regulatory approval; and increasing the willingness to pay threshold (i.e., a higher QALY level for rare disease patients). These are just some examples of mechanisms designed to help patients gain faster access to innovative and potentially life-saving treatments.  In all of these, negotiations with manufacturers remain intact.Following the Government of Canada's recent announcement, $1.4 billion of the investment will be made available to provinces and territories through bilateral agreements; an opportunity to share knowledge, jointly develop a formal definition for rare disease and determine and provide access to new and emerging treatments in a consistent way across the country.We look forward to the opportunity before us – collaborating with the rare disease community to build on the $1.5 billion in funding and aspire to a more ambitious strategy that aligns with exemplary markets, includes key elements like a formal definition, a consistent regulatory pathway, investment in R&D to address the 95% of diseases currently without treatments, incentives and is reflective of the unique needs and realities of the three millions Canadians living with a rare disease. We also thank the federal Minister of Health for prioritizing this national strategy for rare disease patients.Fred Little is Pfizer Canada's Country lead for Rare Disease and Gene Therapy.  In the past 25 years, he has helped bring innovative medicines to over 50 patient markets