Summary of new Canadian law
Bill C-17, An Act to Amend the Food and Drugs Act, reported in our earlier Pharma in Brief has now passed through Parliament and was given Royal Assent on November 6, 2014.
The new provisions include broad powers to allow for the public disclosure of confidential business information in certain circumstances, and amendments that would require disclosure of certain prescribed information concerning clinical trials. The key provisions of the amendments include:
- the Minister may disclose “confidential business information” about a therapeutic product without notice to the owner of the information if it is believed that there may be a serious risk to Canadians;
- the holder of a therapeutic product authorization shall ensure that prescribed information concerning certain clinical trials or investigational tests are made public within the prescribed time and in the prescribed manner;
- the Minister may order the provision of any information the Minister deems necessary regarding a therapeutic product where it “may present a serious risk of injury to human health;
- the Minister may order changes to the labeling or packaging for therapeutic products if it is believed that doing so will “prevent injury to health”;
- the Minister may order a recall of a product or have the product sent to a specified location if that product “presents a serious or imminent risk of injury to health”;
- the Minister may order a manufacturer to conduct assessments on the therapeutic product, compile information, and conduct studies or tests in respect of a therapeutic product and submit this requested information to the Minister; and
- significantly higher fines than what is currently available, including up to $5 million or imprisonment for a maximum term of 2 years, or both, upon conviction by indictment; and unlimited fines and up to 5 years imprisonment for those who wilfully provide false or misleading information to the Minister, or knowingly or recklessly cause serious risk of injury to human health by contravening any other provision in respect of therapeutic products.
Summary of new policy at the European Medicines Agency
Following a consultation which began in November 2012, the European Medicines Agency (EMA) has recently adopted a new policy for the proactive disclosure of clinical reports which will make them more widely accessible to the public.
The new policy will apply to clinical reports submitted to the EMA as part of applications for new marketing authorisations made under the centralised authorisation procedure on or after 1 January 2015; and extension applications made under the centralised authorisation procedure on or after 1 July 2015.
Applicants/MAHs will need to carefully consider what data in the clinical reports to be submitted they wish to redact and to clearly articulate their justifications for any proposed redactions. It will also be necessary for applicants/MAHs to understand what rights they have to challenge a decision of the EMA, their rights against the registered users of the data under contract and how they may be able to prevent misuse by any third party.