DRAFT: May 3, 1996 by Ed Hore 868-1340
The Canadian Drug Manufacturers Association (CDMA) is an association of manufacturers of generic drugs. A full description of the CDMA and its members is behind Tab "A".
The size shape and colour issue
For decades generic prescription drugs in Canada have had similar size, shape and colour as their equivalent brand name product. This promotes patient safety, and is in the public interest.
However, this practice has now been put into jeopardy by a series of lawsuits commenced by brand name companies, alleging that particular new generic products should not have similar size, shape and colour as their reference brand name drugs. In some cases, the courts have held in preliminary motions that the generic drug must have a different size, shape and colour pending the final decision of the court at trial. Essentially every new generic product is now faced with a lawsuit of this kind when it appears on the market.
Canada's laws should be amended
In view of the important health and safety issues at issue, statutory/regulatory amendments are needed, which would require generic drugs to resemble their brand name equivalents. Draft amendments to the Food and Drug Regulations and the Trade-marks Act are set out behind Tab "B".
To ensure that any intellectual property or "passing off" concerns are met, the amendment to the Food and Drug Regulations provide that generic drugs should be imprinted with a code or logo indicating the manufacturer of the product, as is the practice at the present time. This ensures that patients or health professionals who want to know the manufacturer of a particular tablet can immediately identify that manufacturer by a glance at the tablet.
This will maintain the current practice whereby the size, shape and colour of a drug indicates what kind of drug it is, rather than who makes it.
Why a statutory/regulatory change is in the interests of Canadians
There are presently hundreds of generic products in Canada which have similar size, shape and colour as the brand product. The recent spate of court actions begun by brand name companies constitutes a concerted effort to change the staus quo which has prevailed in Canada for many years.
The issue in each court case is confined to the narrow question of whether common law property rights exist in the appearance of one particular brand name drug. It is not within the competence or the jurisdiction of the courts in these cases to consider questions of public safety or the public interest as a whole. Neither the public nor governments are parties to the lawsuits, and are not able to put their concerns before the courts.
Yet the issue concerns all Canadians. It is not merely a private property dispute.
The Health Protection Branch of Health and Welfare Canada has the mandate and the obligation, in view of the health issues at stake, to make appropriate changes to the Food and Drug Regulations in the public interest. The private interests of drug companies should not be permitted to outweigh the interests of Canadians as a whole.
It may also be appropriate for Parliament to amend the Trade-mark Act. However, even if this is delayed, or not done at all, the regulatory change shold be made as soon as possible.
The safety concerns arising from the size, shape and colour of generic drugs
Many groups across Canada have expressed concerns about safety implications of the recent size, shape and colour lawsuits. Their concerns can be summarized as follows:
Similar-appearance generics are a safety check that helps prevent medication mix-ups: At present, if a patient is given a tablet that looks completely different from what he or she is used to, the patient (or perhaps a family member or nurse) will ask, "why?". This provides a vital safety check in the event that a doctor has prescribed the wrong dosage form or medication by mistake, a pharmacist or health professional has dispensed the wrong medication, or the patient or family member takes a tablet out of the wrong container. On the other hand, if generic drugs look different from the originator, then the check is lost: a tablet that looks different may be just another generic version. Medication mix-ups can have very serious consequences. Recently, the wrong dosage of a prescription drug was dispensed to patient in British Columbia, resulting in the death of the patient. This led to a coroner's recommendation that dosages should be distinguished by colour coding for the particular drug in question, and such coding should be uniform for all manufacturers across the industry. The report of the Judgment of Inquiry is behind Tab "C".
Patients, particularly seniors, rely on the appearance to identify their medication. Many patients, particularly seniors, take more than one medication. In a survey of seniors conducted by the CDMA, a majority of seniors stated that they use the size, shape and appearance of the medications to identify their medication. They therefore preferred generic drugs to look like the brand name drug to lessen the likelihood of mix-ups and for the sake of convenience. A copy of the Executive Summary of the report on this survey is behind Tab "D".
Patient compliance will decrease if generic size, shape and colour greatly differs from that of the brand name reference drug. All health care professionals are aware that lack of patient compliance with prescription drug regimes is a major problem. A recent study found that patient compliance with prescription drug regimens for tablets taken 3 times a day is only 38 to 75%. The study estimated the resulting direct costs to the health care system in Canada at $3.5 to $4.5 billion a year. If generic drugs have a completely different size, shape and colour from the originator drug, this problem will increase. Patients are uncomfortable with generic products if they look completely different and therefore less likely to take them regularly or at all.
Similar-appearing generics permit easy identification in emergency situations. In an emergency situation where a patient's stomach must be pumped or some other emergency procedure taken, uniformity of appearance for particular drugs in particular dosage strength makes it easier to identify what medication the patient has taken.
Groups calling for legislation
In recent months, consumers, seniors and professional pharmacists groups across Canada have stated publicly their strong view that the health of Canadians will be put at risk if the courts order the size shape and colour of generic drugs to be completely different from the equivalent originator products. They have called for government action. Copies of the many public statements the CDMA has received on this issue in recent weeks or months are behind Tab "E".
Groups that have called strongly for legislation to continue the present practice include the following:
* The Ontario Pharmacists Association
* The Consumers' Association of Canada (Alberta)
* The West End Seniors' Network Society (Vancouver)
* Consumers' Association of Canada (British Columbia Branch)
* The Royal Canadian Legion
* The Canadian Society of Hospital Pharmacists
* Metropolitan Toronto Pharmacists Association
A summary of the positions of each of groups is provided behind Tab "F" is provided
Please give careful attention to the attached statements and position papers.
There is concern across Canada about this issue. We urge the government of Canada to act to safeguard the health of Canadians.
Food and Drug Regulations
1. The Food and Drug Regulations are amended by adding the following after section C.08.002.1
C.08.002.2 Where the Minister has granted or grants a notice of compliance in respect of a drug on the basis that that drug is the pharmaceutical equivalent or bioequivalent of a Canadian reference product, the dosage form of or an administration device for the drug shall have the same or substantially similar size, shape and colour as that of the equivalent dosage form or administration device of the Canadian reference product, and shall be marked or imprinted with a code imprint indicating the manufacturer or distributor, unless the Minister determines that such marking or coding is not technologically feasible.
1. The Trade-marks Act is amended by adding the following after section 7:
7.1 Where a drug has been granted a notice of compliance under the Food and Drug Regulations on the basis that it is the pharmaceutical equivalent of or bioequivalent to a Canadian reference product, and a dosage form or administration device of that prescription drug has the same or substantially similar size, shape and colour as the equivalent dosage form of the Canadian reference product, that size, shape and colour of the drug shall be deemed not to violate the prohibitions in section 7 and not to constitute infringement under section 20, notwithstanding any interlocutory or final order of any court.