International Rare Disease Day always falls on the last day of February because in Leap Years, it's on the 29th – the rarest of all days. For 2022, we'll see monuments lit up in rare colours across Canada to mark the occasion.Rare Disease Day in Canada is particularly significant this year, and not just because the nearly three million Canadians with rare diseases and their families (since two-thirds of rare diseases are in children) have been severely affected by the COVID-19 pandemic and look forward to improved access to services they need.We're at a tipping point on the issue in Canada, just one month before the long-promised new federal funding for rare disease treatments is scheduled to start flowing. Several years ago, the Trudeau government pledged a two-year, $1 billion injection of new funding starting in 2022, and half a billion thereafter, to ensure what the government calls “fair, consistent and evidence-based access” to specialized medicines.This is excellent news for Canada's rare disease community, and there are indications that provinces are starting to take notice and preparing their public programs accordingly. Just before last year's federal election, for example, P.E.I., which has the lowest funding rate for rare disease medicines, secured a four-year, $35 million federal contribution to help pay for prescription medication costs, reduce co-pays for Islanders and expand access to more medicines, including those for rare diseases.We hope that investment was the tip of the iceberg, and Ottawa's $1 billion promise shows the feds are stepping up. The federal government has been consulting on and developing the plan for how the funding would be used. Good progress has been made and preliminary results are encouraging, especially the core vision, which we can all get behind: to improve access to rare disease treatments for patients.The formal plan couldn't come soon enough, as the rare disease community has waited decades for coordinated government action on the file. The United States and European Union have had dedicated strategies in place since 1983 and 2000, respectively. Here in Canada, the Canadian Organization for Rare Disorders (CORD) launched Canada's Rare Disease Strategy in 2015 – seven years ago – setting out the roadmap for how every stakeholder needs to lead including both levels of government, industry, healthcare professionals, researchers and patients and caregivers.This is especially important for Canada, with our relatively small and increasingly heterogenous population spread across a huge land mass, there are many conditions whose patients are counted in the mere dozens or even single digits. It's an issue that cries out for a national strategy that facilitates shared resources and expertise to ensure equitable treatment for all patients.The new federal funding should help ensure more timely and equitable access for Canadians to the many promising new treatments for rare diseases that have been developed already and continue to flow out of the global innovation system (many right here is this country).While we are hopeful it will reduce the financial obstacles to making these exciting new technologies available to needy patients, it must be recognized that access to treatments involves more than just funding. We also need a regulatory environment that is flexible enough to evaluate new treatments for rare conditions that can't be studied in the same way most medicines are. Large multi-centred clinical trials simply aren't a realistic expectation for these medicines. Often it would be unethical to compare patients on the medication to others who are not receiving the treatment.Canada can also learn from other countries in terms of reducing barriers to access. One approach would be to fund access for patients as soon as new treatments are approved by Health Canada, not years later after a long evaluation and funding negotiation. Several European countries exempt medicines that have small overall budget impacts from having to go through health technology assessments, and almost all developing countries have intellectual property incentives to spur research and launch of rare disease medicines. Canada has a lot of catching up to do.A national rare disease drug strategy for Canada also must recognize that patients need more than treatment support.  While the new federal funding is designated only for medicines, Canadians with rare disorders need better and more accessible screening programs, including at the neo-natal level, and easy access to specialists (some perhaps several provinces away) to diagnose their conditions earlier when they might be more treatable. Also vital is non-pharmaceutical support such as medical and care devices as well as effective programs providing home care and respite assistance for caregivers. The federal government could start doing this by endorsing CORD's 2015 Canadian Rare Disease Strategy.Finally, it's not just about Ottawa as it's the provinces who manage health systems. The provinces need to be positioned to implement the programs from early diagnosis, care pathways, research networks and drug funding. Some important steps are happening in Ontario and Quebec, and this year's elections in our biggest provinces should include platform commitments and debate on rare disease plans.Let's make sure 2022 is the last Rare Disease Day that Canada is alone among developed countries without a formal rare disease strategy.Bob McLay is Chair of RAREi (www.rarei.ca), a group of Canadian biopharmaceutical companies dedicated to developing treatments for rare disorders and the General Manager of Sobi Canada, Inc.