Canada’s health minister is being given a powerful new slate of tools to deal with medical device safety problems.
Under draft guidance issued Thursday, the minister would receive powers to publicize new information about a device’s safety risks and to demand labeling changes, recalls and postmarket studies.
The guidance, which would implement last year’s Protecting Canadians from Unsafe Drugs Act, or Vanessa’s Law, spells out that the health ministry must provide manufacturers with supporting documentation when it wants to take action on a safety issue, and manufacturers will have time to respond and refute the government’s position.
However, if the response is deemed inadequate the minister could order the company to comply. The guidance also would put limits on who can have access to proprietary information devicemakers supply to the ministry to investigate new risks. Only foreign regulatory bodies, expert advisors, and public health and safety personnel could view trade secrets.
Firms Lack Legal Recourse
When Vanessa’s Law was passed in November, some manufacturers feared it would allow the health minister to disclose any trade secrets to virtually everyone, including investors with no role in health and safety.
The new protections may still be inadequate, says attorney Simon Elliott with Foley & Lardner in Washington, D.C., adding they appear to be general statements of principle, rather than legally binding limitations.
The guidance also lacks any legal recourse for companies that feel the health minister disclosed too much confidential business information, Elliott says.
Health Canada has posted an online survey for stakeholders to provide feedback on the guidance. Comments close May 25.