The Canadian Government will soon release new regulations on drug shortage reporting, it has announced. The regulations will require companies to report drug shortages on a new, independently run website.
Drug shortages occur when there is not enough of a product to meet the needs of patients. Due to the complexity of the supply chain for drugs, shortages can occur for a variety of reasons, including manufacturing and distribution issues or unforeseen spikes in demand.
The current system for drug shortage reporting in Canada was created following the launch of the Multi-Stakeholder Steering Committee (MSSC) on Drug Shortages in 2012. The MSSC is a collaboration between the Canadian government, pharmaceutical industry and patient organizations to address the issue of drug shortages. The MSSC is guided by twotoolkits that discuss transparency and communication related to drug shortages.
Drug shortages are currently reported on the industry-run Canadian Drug Shortage Database website.
New Drug Shortage Reporting Requirements Coming Soon
Canada's announcement regarding new drug shortage reporting regulations come after a 2014 public consultation, which asked industry, healthcare providers and patients to submit feedback on Canada’s current drug shortage reporting measures.
Specific details about the mandatory drug shortage reporting requirements are still forthcoming, and it remains unclear what additional changes or requirements, if any, will be made.
To give the new regulations teeth, the Canadian government will impose fines and penalties on companies who do not comply with the reporting requirements. In the meantime, Health Canada will host a Public Notification Register on its website that will list any companies that do not voluntarily report drug shortages.
International Efforts to Address Drug Shortages
Other regulators have recently stepped up their efforts to address the issue of drug shortages.
In the US, manufacturers are required to report drug shortages six months prior to an interruption or discontinuance under Title X of the Food and Drug Administration Safety and Innovation Act (FDASIA). Prior to the passage of FDASIA in 2012, drug shortage reporting was limited to sole manufacturers of products and excluded biologics from reporting requirements. In 2013, FDA proposed changes to its regulations to implement the provisions of Title X of FDASIA.
In the EU, marketing authorization holders (MAHs) are required to pre-notify national competent authorities (NCAs) if one of their products “ceases to be placed on the market, either temporarily or permanently … no less than 2 months before the interruption.” In a separate Directive, manufacturers are required to inform NCAs of “any defect that could result in a recall or abnormal restriction on supply.”
In its 2012 Reflection paper on medicinal product supply shortages caused by manufacturing/Good Manufacturing Practice (GMP) compliance problems, the European Medicines Agency (EMA) called for marketing authorization holders to voluntarily report potential drug shortages related to manufacturing/GMP issues.
More recently, a group of European pharmaceutical industry associations proposed a set of guidelines it said would help the industry to comply with drug shortage reporting requirements. The group argued that harmonized standards for what is reported and when would reduce the complexity of drug shortage reporting across multiple NCAs.
Government of Canada Announcement