Another year has passed, and still legislation amending the Food and Drugs Act (Act) has not been reintroduced. In our 2010/11 Life Sciences & Law Current Issues update, we had noted that the prior amending bill, Bill C-51, would have made substantial amendments to the Act, but it died on the Order Paper when the Canadian Parliament was prorogued in 2008. That said, expectations are, again, that legislation will become a reality in due course, given that the current Act has not been substantially amended for over 50 years. With a new majority government elected in May 2011, it is possible the legislation will be a priority. The prior bill proposed changes to the law respecting all products covered under the Act — prescription drugs, over-the-counter drugs, devices and natural health products (NHPs) — however, concerns were raised by the natural health product industry that caused some pause over whether the Act should change the rules for NHPs. Accordingly, if legislation is reintroduced, NHPs may not be treated in a similar manner, or included at all.
In the meantime, in the absence of legislative change, Health Canada offi cials moved forward with broad-based consultations, which began in October 2010. The consultations centre around proposed changes to all therapeutic product areas excluding NHPs — prescription and non-prescription drug regulations, as well as those relating to medical devices. Patients and consumer advocates, health care professionals, academics and industry are among the stakeholders consulted. Regulations on food are not included in the process at this time.
Health Canada held a series of consultation sessions in late 2010 and early 2011 and stakeholders were invited to comment further through written input, recognizing that even in the absence of new statutory provisions, many of the changes proposed could be accomplished within the current authority of the Act.
The primary goal of the proposed changes is to permit the regulator, Health Canada, to follow more of a life cycle approach to regulating products in the pre-market phase through to the post-market phase, and to allow Health Canada more agility to deal with issues as they arise. While draft regulations have not yet been presented, the consultations have proceeded on the basis of broad concepts being considered.
Some of the more notable changes proposed are:
- Moving from a one-time issuance of a “Notice of Compliance” to a “Market Authorization,” with terms and conditions that will evolve over time and will allow more fl exibility for the regulator;
- Requiring prescription drugs a pre-notifi cation period of at least six months prior to fi ling a submission for product approval;
- Requiring notifi cation, six months in advance, of discontinuing manufacturing of a drug when it has a public health impact;
- Publication of negative decisions, i.e., posting of reasons for Health Canada refusing to grant a Market Authorization;
- Implementation of defi nitions for “orphan drug” and “rare condition,” paving the way for separate policies for these products for the fi rst time in Canada;
- Providing regulatory rules for submission, labelling and post-market requirements of subsequent entry biologics (also known as SEBs, and in other countries, biosimilars or follow-on biologics);
- Granting Health Canada the ability to impose “special” conditions beyond the standard conditions for a product that could relate to the use of the product as well as the collection and assessment of information about the product’s benefi ts and/or risks;
- Altering and possibly placing further restrictive limits on direct to consumer advertising; and
- Granting Health Canada the ability to request reassessment of product benefi ts and risks.
It is expected further consultations will be held prior to the development of actual regulatory language for consideration, so fi nal regulations are likely to be a few years away. While the current regulatory reform proposals do not address NHPs at all, in due course, it is expected we will see how the government chooses to deal with these products, and whether they will be subject to a completely separate legislative authority outside of the Food and Drugs Act, or whether they will continue to be bound by the same framework as other therapeutic products.
As a fi nal point, SEBs continue to be a popular topic for discussion within industry. While regulations that set the pathway for SEBs are still some time away, it is expected regulatory developments in the U.S., as well as in Europe, which is considering the policy for monoclonal antibody biosimilars, will have infl uence. Gowlings will continue to update its Biologics Portal (www.biosimilars.ca) as changes emerge in Canada, the U.S. and Europe.