Tag Archives: FDA

Mark Warner was featured on Global News National talking about Florida getting U.S. Food and Drug Administration approval to import cheaper drugs from Canada and Canada’s ability to block some bulk prescription drug exports. (January 5, 2024) Mr. Warner was Legal Director of the Ontario Ministry of Economic Development & Trade and advised Ontario trade and investment negotiation and dispute settlement matters including NAFTA . Mr. Warner, a Canadian and U.S. lawyer, who has practiced in Toronto, Washington, D.C., New York and Brussels, and has advised pharmaceutical companies on pricing, distribution and other competition and trade matters. Mr. Warner has also advised governments on trade policy and trade negotiations and previously worked on trade and competition issues as counsel in the OECD Trade Directorate, where he represented the OECD at meetings of the WTO Working Group on Trade and Competition Policy.

Mr. Warner has assisted pharmaceutical clients in the global distribution of HIV / AIDS anti-retroviral drugs and the development of innovative patient access programs in the developing world, advised a U.S.-based pharmaceutical company and its French and South African subsidiaries in a cartel investigation involving 11 leading global Pharmaceutical companies in South Africa and advised a U.S.-based pharmaceutical company on competition law issues relating to the distribution of various nuclear medicine imaging agents in Canada.

As Legal Director of the Ontario Ministry of Economic Development & Trade, Mr. Warner advised Ontario on the negotiations of the Canada-EU Trade Agreement (CETA) including on IP, patent litigation and drug reimbursement issues and on economic development, research and innovation grants and loans to corporations, including leading global pharmaceutical companies for research, manufacture and clinical trial projects. As Legal Director of the Ontario Ministry of Research and Innovation, Mr. Warner also led Ontario’s legal team in creating the $250 million Ontario Emerging Technologies Fund with an emphasis on life-sciences companies and advised on legal and corporate governance issues in the formation of Clinical Trials Ontario.

Mark Warner was featured in the Wall Street Journal talking about some of the reasons for the Canadian difficulty of delivering COVID19 vaccines. (April 8, 2021) Mr. Warner is a Canadian and U.S. lawyer who has practiced in Toronto, Washington, D.C., New York and Brussels and has advised governments on trade policy and trade negotiations and previously worked on trade and competition issues as counsel in the OECD Trade Directorate.

Mr. Warner has assisted pharmaceutical clients in the global distribution of HIV / AIDS anti-retroviral drugs and the development of innovative patient access programs in the developing world, advised a U.S.-based pharmaceutical company and its French and South African subsidiaries in a cartel investigation involving 11 leading global Pharmaceutical companies in South Africa and advised a U.S.-based pharmaceutical company on competition law issues relating to the distribution of various nuclear medicine imaging agents in Canada. Mr. Warner was Legal Director of the Ontario Ministry of Economic Development & Trade and advised Ontario on the negotiations of the Canada-EU Trade Agreement (CETA) including on IP, patent litigation and drug reimbursement issues and on economic development, research and innovation grants and loans to corporations, including leading global pharmaceutical companies for research, manufacture and clinical trial projects. As Legal Director of the Ontario Ministry of Research and Innovation, Mr. Warner also led Ontario’s legal team in creating the $250 million Ontario Emerging Technologies Fund with an emphasis on life-sciences companies, drafted funding agreements, including for the Ontario Research Fund and Ontario Brain Institute, and advised on legal and corporate governance issues in the formation of Clinical Trials Ontario.

In addition, Mr. Warner, led the Province’s legal team for the insolvency / restructuring of General Motors and Chrysler in the difficult context of the 2008-2009 Recession.

Mark Warner was featured in the Wall Street Journal talking about the National Advisory Committee on Immunization recommendation that Canadian governments halt on administering the AstraZeneca COVID19 vaccines to people under the age of 55 . (March 29, 2021) Mr. Warner is a Canadian and U.S. lawyer who has practiced in Toronto, Washington, D.C., New York and Brussels and has advised governments on trade policy and trade negotiations and previously worked on trade and competition issues as counsel in the OECD Trade Directorate.

Mr. Warner has assisted pharmaceutical clients in the global distribution of HIV / AIDS anti-retroviral drugs and the development of innovative patient access programs in the developing world, advised a U.S.-based pharmaceutical company and its French and South African subsidiaries in a cartel investigation involving 11 leading global Pharmaceutical companies in South Africa and advised a U.S.-based pharmaceutical company on competition law issues relating to the distribution of various nuclear medicine imaging agents in Canada. Mr. Warner was Legal Director of the Ontario Ministry of Economic Development & Trade and advised Ontario on the negotiations of the Canada-EU Trade Agreement (CETA) including on IP, patent litigation and drug reimbursement issues and on economic development, research and innovation grants and loans to corporations, including leading global pharmaceutical companies for research, manufacture and clinical trial projects. As Legal Director of the Ontario Ministry of Research and Innovation, Mr. Warner also led Ontario’s legal team in creating the $250 million Ontario Emerging Technologies Fund with an emphasis on life-sciences companies, drafted funding agreements, including for the Ontario Research Fund and Ontario Brain Institute, and advised on legal and corporate governance issues in the formation of Clinical Trials Ontario.

In addition, Mr. Warner, led the Province’s legal team for the insolvency / restructuring of General Motors and Chrysler in the difficult context of the 2008-2009 Recession.