Mr. Speaker, I will be splitting my time with the member for Barrie. I am pleased to have the opportunity today to take part in this very important discussion about thalidomide and to pay tribute to the 12,000 babies in 46 countries who were born with malformations.

Like all Canadians, I am saddened to know that only some 8,000 of these babies made it past their first birthday. Let me assure the House, as has already been expressed by other members on this side of the House, that we will be supporting the motion today.

Many of my colleagues are contributing to this debate by bringing forward varying perspectives, sometimes their own personal stories or experiences, to this very important issue. However, if the best predictor of future behaviour is indeed past behaviour, it is important to consider the historical perspective of the regulatory framework in our country.

It is important to consider what was in place in the late 1950s and the early 1960s, and how this framework has evolved since then. The thalidomide experience caused the government to overhaul the Canadian drug regulatory framework. As a result, Canada has one of the safest and most rigorous drug approval systems in the entire world. The system is continuously evolving and improving as we find new ways to better protect the health of all Canadians.

These changes include the very recent improvements brought forward through Bill C-17, known as Vanessa's law. This bill, brought forward by the Minister of Health received royal assent earlier this month.

Canadians can rest assured that I am fully conscious of the fact that whatever improvements have been made since the thalidomide tragedy, they are of no relief whatsoever to the victims, their families, and friends. Nothing can ever undo the pain and suffering inflicted.

That being said, I feel it is very important to look back at the history of our regulatory framework. The history of federal oversight of foods and drugs in Canada started some 150 years ago and predates Confederation. Oversight was initially confined to ensuring that food and drugs were not adulterated.

The Proprietary or Patent Medicine Act of 1909 was the first legislation to register medicines. Although limited in scope, that act was the beginning of this country's legislative protection of the public against drugs administered without medical supervision. This regime prevailed until 1920, at which time the Food and Drugs Act was introduced. This followed the establishment of a federal Department of Health the previous year.

By the late 1920s, regulations developed under the Food and Drugs Act established specific requirements for the licensing of drugs. At that time, the Minister of Health had the authority to cancel or suspend a licence if these requirements were violated.

A significant reworking of the food and drugs regulations did not begin until 1947, but it laid the foundation for the regulations that are in place today. By 1951, and as is still the case today, manufacturers were required to file new drug submissions prior to marketing their drugs. As I said, that has not changed. However, the required content of these submissions has since changed significantly.

It is under that regulatory regime that thalidomide was first approved for sale in Canada to treat sleeplessness and morning sickness. More specifically, it was approved in November 1960 under the brand name, Kevadon, and again in October 1961 as Talimol.

In 1962, the drug was withdrawn from the Canadian market when it was discovered that it caused birth defects when taken during pregnancy. However, by then a lot of damage had already been done.

As I said previously, approximately 12,000 babies in 46 countries were born with malformations. In Canada, it is estimated that more than 100 Canadian families were impacted. The tragic circumstances surrounding thalidomide's removal from the market in the 1960s prompted a complete revision of the Food and Drugs Act and the food and drug regulations. These revisions were made to strengthen Health Canada's regulatory oversight and data requirements for new drug submissions.

The government asked the Royal College of Physicians and Surgeons to appoint a special committee to review new drug procedures under the Food and Drugs Act. The intent was to critically review the act and associated regulatory powers in order for Health Canada to more effectively carry out its purpose and to protect the public.

In December 1962, new legislation was introduced that substantially broadened Health Canada's powers. For the first time, Health Canada was given the authority to enact regulations respecting the distribution or conditions of distribution of drug samples; the prohibition of sale of certain drugs; the methods of preparation, manufacture, preservation, packing, labelling, storing, and testing of new drugs; and the sale or conditions of sale of any new drug. In January 1963, a complete revision of the Food and Drug Regulations concerning the sale and distribution of new drugs was finalized, and new regulations were arrived at in October 1963. These revisions imposed strict safety requirements. For the first time, manufacturers were required to produce “substantial evidence of the clinical effectiveness of the new drug”, including clinical case reports and in vitro studies, in addition to the previous safety requirements.

At the time that thalidomide was initially authorized, the package of information related to the drug was limited, contained in only a small binder of data. Now the volume of data received by Health Canada for the review of a new drug can fill several hundred binders, with safety, efficacy, and quality-related data.

Given the observations noted by the special committee in the 1960s, drug distribution was also an important issue to be addressed in revising the Food and Drug Regulations. The situation was brought into focus when it was disclosed that the greatest distribution of thalidomide was to the medical profession, as free samples to give to patients. Reports also surfaced that individuals were taking delivery of these unsolicited samples and selling them to wholesalers, pharmacists, and others. The Food and Drug Regulations were therefore amended to discourage excessive and unsolicited sampling, through maintenance of complete distribution records by manufacturers.

Today, the post-thalidomide 1960s revisions of the Food and Drugs Act and the Food and Drug Regulations regarding Health Canada's regulatory responsibilities, the new drug submission requirements, as well as the distribution and sampling of prescription medicines, remain substantially the same. As science has evolved, the revised framework has allowed Health Canada to require appropriate and through studies to support drug approvals. Through the Food and Drugs Act and its regulations, Health Canada regulates the safety, efficacy, and quality of pharmaceutical drugs. The pharmaceutical drugs program involves pre-market review, post-market surveillance and compliance, and, of course, enforcement.

As I mentioned earlier in my remarks, the most recent substantive revision to the Food and Drugs Act, completed earlier this month, is the recently adopted Bill C-17, Vanessa's law. This legislation enables Health Canada to better respond to drug safety issues and improve patient safety related to prescription and over-the-counter drugs, vaccines, gene therapies, cell tissues and organs, and medical devices. It includes new measures to strengthen safety oversight of therapeutic products over their life cycle. These measures are intended to improve Health Canada's ability to collect post-market safety information, take appropriate action when a serious health risk is identified, and help ensure that drug safety information is available to Canadians. As well, these measures serve to promote greater confidence in the oversight of therapeutic products by increasing transparency and improving safety of their use.

In Canada, manufacturers must now file a submission with Health Canada and receive authorization before a new drug can be marketed. These submissions contain substantial information and data about a drug's safety, effectiveness, and quality, as well as side effects, warnings, precautions, and contraindications. Health Canada also continues to enhance its post-marketing surveillance and assessment of programs for health products. Comprehensive evaluations include information from post-marketing surveillance, on a global scale, to determine whether the benefits of a marketed drug continue to outweigh its risks.

The 1960s thalidomide tragedy highlighted the need to reform Canada's drug approval process, and prompted a modernization of the Food and Drugs Act and underlying regulations, which has shaped today's drug regulation standards in Canada. The drug review process continues to evolve and improve, but five decades after the thalidomide tragedy, the initial legislative reforms brought about by the result of this sad chapter in our history continues to underpin Health Canada's legislation and practices.

I look forward to hearing about the minister's constructive meeting with the Thalidomide Victims Association of Canada and what support we can offer these victims.

Colin Carrie

$516,145.00