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The Evidence on rBST

A. The Safety of rBST for Humans

The Committee received contradictory evidence on human safety aspects of rBST. Naturally occurring bovine somatotropin (BST) indirectly affects mammary cells through the insulin-like growth factor 1 (IGF-1), a mediator produced in the liver. As a result, both BST and IGF-1 are found naturally in milk. The injection of rBST increases the level of IGF-1 in the cow. As pointed out to the Committee by Mr. Mark Feeley, a member of the internal review team from the Bureau of Chemical Safety, IGF-1 is also a naturally occurring hormone in the human body and there is some scientific evidence to suggest that it may have an influence on human prostate cancer and human breast cancer, since it does promote the growth of cells. A study undertaken at Harvard University showed links between IGF-1 levels in the blood and prostate cancer. Supporters of the drug argue that it does not change the composition of milk in any significant manner, and that no health risk is posed to those who may consume residues of rBST and IGF-1. Others suggest there is not yet sufficient evidence to assure human safety, bearing in mind that exposure to those residues may occur over a lifetime.

Health Canada scientists who authored the Gaps Analysis Report, and the subsequent Internal rBST Review report, concurred that the standard data package of acute, sub-acute and chronic studies, two-generation reproduction studies, teratology studies, and residue studies was not part of the Nutrilac submission. In their view, this meant that such long-term health risks as sterility, infertility, birth defects, cancer and immunological consequences had not been investigated. They were also concerned about the lack of evidence to assure that human health would not be compromised through increased use of antibiotics in treating rBST side-effects in cows. There is now concern among health officials that antibiotic-resistant pathogens can develop in food-producing animals and be passed on to humans.

For eight years, as the standard data package requirements were waived, the international scientific community held that rBST and IGF-1 residues posed little or no problem because, as proteins, both would be broken down in digestion and would not reach the blood stream where they might affect other cells or organs. It was also claimed that rBST is considered biologically indistinguishable from natural BST (the difference is one amino acid in 191) and that the injection of rBST does not change the composition of milk in terms of BST and IGF-1 levels.

In January 1998, however, the Health Canada internal review team found evidence that rBST is not broken down in digestion. They noted the effects of the drug on test animals in a 90-day rat study conducted in the late 1980s for Monsanto and contained in the manufacturer's New Drug Submission. The Gaps Analysis Report noted that 20 to 30% of test animals that received high doses of the drug orally for 90 days produced antibodies to it. Some also showed evidence of cysts and other early effects. Some studies suggest an increase of IGF-1 levels in rBST milk, and evidence that IGF-1 is not broken down in digestion but survives in the presence of casein, a milk protein. Recent articles in scientific journals suggest that elevated IGF-1 levels are associated with a higher incidence of breast and prostate cancer, showing that IGF-1 may have local effects.

The Committee also heard from witnesses who found no need for new human safety research. Mr. Ray Mowling, of Monsanto Canada, told the Committee there are "exhaustive scientific studies that address long-term risks to human health, and (that) overwhelmingly (point) to BST's safety for humans, as well as animals." He cited respected authorities, including the Canadian Paediatric Society and a Canadian Medical Association Scientific Panel, that had found no evidence of risk to human health associated with rBST. As Dr. Mueller pointed out, however, many credible bodies that have formed opinions on rBST have "looked at summaries and, overall, it looks pretty good." Few have examined the raw data and how these were generated.

The Committee also received evidence that mitigates concern about rBST and IGF-1 residues in milk. There is controversy about the effect of milk pasteurization on rBST. It is claimed that pasteurization denatures rBST. Information contained in Appendix XI of the Gaps Analysis Report, however, indicates that this assumption was only based on a study using higher pasteurization temperatures than the legal minimum required in Canada. IGF-1 is not destroyed by pasteurization, and different claims have been made about the effect of heat on the preparation of infant formula. In his statement to the Committee, Dr. Paterson, Director General of Health Canada’s Foods Directorate, said that at least 50% was destroyed, while some papers have reported that 90% was destroyed. The Committee was also told that the additional amount of IGF-1 that people might drink in milk is a "drop in the sea" of the IGF-1 produced naturally in their bodies.

Dr. Jock McLean, of Australia's Swinburne University of Technology, served on the 1998 JECFA. He told the Committee that, in the opinion of the JECFA, an rBST-prompted increase in IGF-1 milk posed no risk. In the worst case, people would consume 2,000 nanograms of IGF-1 in a litre of milk, compared to the 10 million nanograms their own bodies produce daily. He noted that he has examined rBST in committees for a decade, and in his opinion there are no unresolved issues of human safety.

From a different perspective, Dr. Michael Hansen, of the Consumer Policy Institute of the U.S. Consumers Union and a temporary advisor to the JECFA, told the Committee that it is misleading to compare IGF-1 levels in milk with the levels that people produce naturally and conclude that a 1% increase is not significant. Milk casein not only protects the IGF-1 from digestion, it also slows down the process, making the additional IGF-1 available in the body system 17 times longer than IGF-1 not found in milk. He concluded that "(f)or some people that would be significant." Dr. Hansen also said that he had examined the science on rBST for a decade and believes the 90-day rat study is crucial. He said the antibodies found in the blood of rats could not be explained away by the study's methodology. He also noted that the reaction was prompted by amounts of rBST smaller than the levels of other food proteins needed to trigger allergies. He agreed with the Gaps Analysis Report that the 90-day rat study should have prompted longer-term studies.

The Committee is aware that the U.S. Food and Drug Administration (FDA) has approved rBST, and that the JECFA claims there is no need to limit the level of rBST and IGF-1 residues in milk in order to protect human health. Laws in the United States do not require milk from rBST-treated cows to be labelled as such, although it is possible to label milk as being "rBST-free." Where this is done, however, it must also be indicated that the FDA has determined that there is no significant difference between the milk from cows treated with rBST and the milk from cows that have not been treated. The Committee heard testimony, however, from Mr. Anthony Pollina, of the Vermont Public Interest Research Group, who suggested that the FDA approval process can be "characterized by misinformation, by cover-up, by the skewing of data, by violation of the approval process rules at the FDA and conflicts of interest between the FDA and Monsanto." Regarding the FDA process, Dr. Hansen said the agency had misreported the results of the 90-day rat study in the journal Science in 1990 when it concluded there were "no toxicologically significant changes" in the rats that had received the drug. He said the Consumers Union, the largest U.S. consumer organization, has urged the U.S. Congress to investigate. Mr. Pollina also provided the Committee with a letter from U.S. Senators representing the state of Vermont asking for information from the agency as a result of the Health Canada scientists' reports.

The Committee believes that, while the findings and data of such bodies as the FDA and the JECFA can assist the Health Canada decision-making process, Canadians must know that the final decision will be made domestically.

The Health Canada internal review team scientists agreed on the gaps in the science on rBST, but they differed on how best to deal with them. In testifying before the Committee, they did, however, agree that their recommendations are complementary. Two members of the rBST internal review team who evaluate veterinary drugs daily told the Committee that they recommended new long-term studies to answer the unresolved issues. They suggested to the Director General of Health Canada's Food Directorate that the manufacturer be asked to provide the studies noted as missing by all members of the internal review team, namely: long-term toxicology studies to ascertain human safety, investigation of such possibilities and potentials as sterility, infertility, birth defects, cancer and immunological derangements; and studies addressing the anticipated increase in rBST-related infective mastitis, antibiotic therapy and resulting antibiotic resistance in the farm-borne pathogens of humans.

Two members of the internal review team who work in other Health Canada divisions told the Committee that they had greater concern about IGF-1 residues of rBST itself. Although their report recommends no new long-term studies, it does suggest: another 90-day study into the effects on rat pups to oral exposure to milk from rBST-treated cows; bioassays to characterize the immunological response to rBST and IGF-1 (the Human Safety Division that has already signed off on the drug would then decide whether long-term studies were needed); and consideration of a post-approval monitoring program in Canada to determine whether an increase in mastitis could lead to the development of antibiotic resistance.

In their statement to the Committee, these two scientists also suggested an exposure assessment for IGF-1. They proposed an investigation of the validity of assay methods used to measure IGF-1 so that the results of the different studies can be compared and the level of IGF-1 in the milk of cows to which rBST has been administered over a long period of time (more than two lactations, without the use of dilution factors). They also proposed an evaluation of the impact on IGF-1 activity of current milk processing practices in Canada, and a verification of the amount of IGF-1 from rBST milk absorbed into the systemic circulation when ingested. Finally, the exposure assessment would include a comparison of levels of biologically active IGF-1 retained in the gastrointestinal tract after consuming milk from cows that have been chronically treated with rBST with the levels produced endogenously.

The Committee wishes to comment on their recommendation regarding a post-approval monitoring program. It has received a written statement from Dr. Losos that a conditional Notice of Compliance is not legally permissible for veterinary drug products; human and animal safety and efficacy must be assured before an NOC is granted. This would hold true for the human health risk of development of antibiotic resistance. Therefore, a post-approval monitoring program could serve only as a secondary check to confirm the safety established by other studies.

The Committee heard evidence that the Post Approval Monitoring Program (PAMP) performed by Monsanto in the United States and reviewed by the JECFA had addressed the issue of antibiotic residues. It suggested there had been no significant rBST-prompted increase in drug residues during the two years following the approval of the drug in the United States. Dr. Hansen, however, questioned this conclusion. He testified that the PAMP was "fundamentally flawed because no data were taken on the actual antibiotic residues in milk from treated cows." He told the Committee that PAMP data gathered from 12 States did show an increase in milk discarded due to antibiotic residues, but that the JECFA and the FDA claimed that this could be partly explained by a change in residue testing methods. Dr. Hansen, however, questioned their explanation. Other witnesses suggested that potential increases in antibiotic residues in milk could be managed through existing dairy industry practices. Milk must be tested and found free of antibiotic residues before it is processed. The Gaps Analysis Report noted, however, that testing is likely to miss many drugs, particularly the "off-label" use of some of the more than 150 antibiotic drugs now available but not approved for treating specific animal diseases. The Report noted that "(t)he existing antibiotic testing program cannot guarantee that no illegal residues are present in the milk supply."

Given conflicting evidence and testimony, and differing opinions on the need for further study, the Committee believes that the scientific evidence does not lead directly to the conclusion that rBST residues are unsafe, or that people consuming the products of rBST-treated animals in countries where the drug is used are risking their health. Rather, in the Committee's view, the evidence and testimony highlight the need for additional studies. The Committee is persuaded by the questions posed by Dr. Mueller in her statement to the Committee. She said that:

"In summary, the main toxicological concerns that have been raised with respect to the use of rBST are: (a) would rBST residues be absorbed intact from the gastrointestinal tract in sufficient quantities to produce a toxic and/or immunologic response; and (b) would IGF-1 residues in milk or milk products survive the gastrointestinal tract environment to produce localized effects, or be absorbed intact and remain bioactive in sufficient quantities to produce systemic effects?"

The Committee believes that the Internal rBST Review report provides valuable suggestions on how those questions might be answered, and recognizes the opinion of the human health expert advisory panel with respect to the 90-day rat study. The Committee feels that, in cases of scientific uncertainty, the precautionary approach is the wisest course of action. Since rBST is a non-therapeutic drug whose residues in milk could be consumed over a lifetime, the Committee holds the view that a cautious, science-based approach is required. For this reason,

  1. the Committee recommends that no Notice of Compliance be issued for rBST until the manufacturer submits the long-term studies identified by Health Canada's rBST internal review team as data missing from its submission and until a review of those studies more precisely determines any risks to human safety.

 

B. The Safety of rBST for Animals

The Health Canada internal review team did not investigate the animal safety review process, aside from matters that touched on human safety. It did note, however, that the Bureau of Veterinary Drugs was analyzing the U.S. PAMP that examined some of those matters. The Bureau also received the Posilac product label, which lists some 21 potential adverse effects on animals that receive the drug, including mastistis, reproductive problems and lameness. While the Posilac label does list a number of possible side effects, Monsanto noted that these effects "may occur" or that the drug's use "may increase the risk." The Committee received no information on the details of the BVD's analysis of the PAMP; moreover, at this time it does not have the benefit of the opinions of other veterinary experts who have asked to present evidence to the Committee. Monsanto officials testified that the PAMP revealed nothing in those herds to which rBST had been administered that does not occur in dairy herds generally.

While the Committee's mandate is to study the effects of rBST on both animals and humans, much of the testimony pertained chiefly to human safety; the Committee intends to hold additional hearings, which will provide an opportunity for more extensive testimony related to animal safety. The Committee did, however, receive conflicting anecdotal evidence from dairy farmers and a report prepared by the Government Relations Director of the Wisconsin Farmers Union describing adverse effects on animals noted by several U.S. dairy farmers. Ms. Joyce Hutchings, an Ontario dairy farmer appearing on behalf of the National Farmers Union, also told the Committee of her observations while visiting New York State and provided information on one dairy producer who had received premium payments for his milk prior to using Posilac but who had lost much of his herd to disease and nearly lost his farm after using it.

On the other hand, Ms. Linnea Kooistra, an Illinois dairy farmer who appeared with Monsanto, commented on mastitis by noting that "… it comes down to keeping your cows clean and your equipment in good working order to try to lower somatic cells so your cows do not get mastitis." She also told the Committee that "( c) ows are our livelihood. We would not be doing anything to our cows that would not be healthy for them because we rely on them for our living." Moreover, Dr. Michelle Wieghart, a Wisconsin dairy farmer who appeared with Monsanto and a former professor of dairy production with a specialization in nutrition, noted that in milk produced on her farm she has not seen any changes in the level of somatic cell counts that are indicative of animal health problems, nor has she experienced any other concerns about animal health and rBST use.

Nevertheless, some analysis undertaken at the University of Sussex using the same raw data as Monsanto showed an increased incidence of mastitis. Finally, the CNS/Endocrine/Antiparasitic Division (now the Pharmaceutical Assessment Division) refused an NOC on several occasions because the adverse side effects of rBST administration outweighed the benefits, namely the degree to which milk production is increased. The Committee notes that, when the NOC for target species efficacy and safety was refused in 1995 by the CNS/Endocrine/Antiparasitic Division, the manufacturer was asked to provide an additional Canadian study. The methodology was submitted and reviewed, but the study was never done. From this perspective,

  1. the Committee recommends that Health Canada ask that the study requested by the evaluators of the former Central Nervous System/Endocrine/Antiparasitic Division be conducted and submitted in order to meet the requirement of section C.08.004.(2) of the Food and Drug Regulations.

 

C. Other Aspects of rBST Use

The Food and Drugs Act does not permit Health Canada to include non-scientific considerations in its decision to approve veterinary drugs. The Committee did, however, receive testimony on economic, trade and other implications of rBST use.

In speaking of the economic benefits of rBST use, some witnesses testified that rBST is a production tool that dairy producers should have the option of using. Dr. Robert Bell, a veterinary practitioner who appeared with Monsanto, testified that any tool that lowers production costs or can cost-effectively increase revenue without capital expenditures is a "godsend" in the 1990s, particularly for smaller dairy farms, since most technologies that lower cost first require large capital expenditures. In his view, rBST use is more profitable than such alternatives as three-times-a-day milking, which has labour and lifestyle implications. Mr. Mowling made the point that "(s)hould the product be registered, farmers and veterinarians can clearly voice their thoughts by either buying it or not. If there is no demand, the product will not be used."

Ms. Kooistra informed the Committee of the benefits of rBST use on her farm. She views the hormone as a management tool that allows cows to be kept on the farm longer, and feels that its use has also resulted in increased awareness of management issues. She argued that "… as independent producers, we feel we should have the choice to use whatever technology is available that can help us in our business." In her view, "(without rBST), … we would have to build a barn, we would have to increase the veterinarian costs, increase utility costs and all those other things. With (rBST), we are able to get more milk, with the same amount of cows."

The particular benefits of rBST for small operations were highlighted by Dr. Wieghart, who also views the hormone as a tool that is especially useful for small dairy producers. She told the Committee that rBST "… is a tool that is particularly well suited for small herds. We had no big initial investment to use that product. … (I) can milk 38 cows in a 38-cow barn instead of milking 46 cows and get the same amount of milk out of those 38 cows." In addition to avoiding the capital expenditure outlay, use of the hormone saves the farmer from having to purchase additional cows. Noting the experience in Ontario and Quebec over the last two years, Dr. Bell made the point that the purchase of cows carries with it the risks of disease transmission between herds.

Other witnesses, however, told the Committee that rBST is not needed if the goal is increased milk production, since this can be achieved without using the hormone. Mr. Baron Blois, of the Dairy Farmers of Canada, noted that in recent years he has changed his feeding program from silage and a grain twice daily to a total mix ration, thereby increasing production significantly. In view of the other means of increasing production, some witnesses questioned why rBST would or should be approved when there are possible detrimental effects for both humans and animals, particularly in the absence of identified need.

Concerns were also raised about the difficulties of giving consumers in Canada a choice between rBST-free milk or milk from cows to which rBST has been administered. Mr. Tim Finkle, of the National Dairy Council of Canada, noted the difficulties and cost associated with segregation at pickup, delivery and processing. He suggested that the segregation of milk could cost about $500,000 per plant, and could only be done at a smaller plant; milk segregation would be extremely costly, with the result that the price of all dairy products could rise and consumption could fall. In the view of the National Dairy Council, which is opposed to rBST, farmers who use rBST should absorb these costs. A related issue raised by some witnesses was labelling. Most argued that if rBST is approved for use in Canada, labelling must give consumers the opportunity to make an informed choice. Retailers could also incur segregation costs.

From a trade perspective and using rBST as an example, some Committee members are concerned with the role that could be played by the Codex Alimentarius Commission in decisions about drug approvals. Although nations are not obliged to abide by decisions of this standards-setting body, the World Trade Organization (WTO) increasingly uses Codex Alimentarius Commission decisions as a technical and scientific reference when resolving trade disputes between countries. According to Mr. John Verrall, of the United Kingdom Food Ethics Council, the European Union (EU), which has a moratorium on rBST, is not likely to be challenged under the WTO because it does not deny access to dairy products from countries where rBST is used. In his view, a trade challenge is unlikely, no matter what the outcome in June 1999, unless countries reconsider giving access to dairy products from countries using rBST.

At this time, Canada's position mirrors that of the EU, in that Canada does not restrict imports of milk and dairy products from the United States. Some Committee members believe this access should be reconsidered. In this case, strong scientific arguments would be needed if Canada’s position were challenged under the WTO. Committee members who travelled to Europe to discuss the upcoming round of WTO negotiations, among other issues, were told that while it is unlikely that rBST will be approved for use in the EU, consumers do not appear to be upset that they may be consuming the products of cows to which rBST has been administered; labelling of these products does not occur.

An environmental argument for the use of rBST was also brought to the attention of the Committee. Dr. Bell said that increased cow efficiency results in a decreased environmental impact, in terms of reduced urine, methane and manure output per unit of milk from rBST-supplemented cows. Other witnesses, however, testified about potential negative environmental impacts. Ms. Jennifer Nelson, a dairy farmer, Rural Vermont Board member and State legislator, argued that "… more feed (induced by rBST injections) means more manure to manage as well, which means more land or too many nutrients on our limited land base." She also noted that rBST use could lead to lost production, and additional costs for antibiotics and veterinary care incurred by mastitis.

From an ethical viewpoint, Mr. Pollina shared his view that rBST "… is a production drug. It is not a therapeutic drug. It does nothing for society, whatsoever. It does not cure disease, it does not benefit consumers or society. Its only purpose is to force cows to make more milk. Given this complete lack of benefit, there should be absolutely no risk at all to consumers from its use."

In addition to the human and animal health and safety aspects of rBST use, other factors -- economic, trade, and ethical to name but a few -- do exist. While these may, and should, be secondary to human and animal health and safety, the Committee believes that they merit some examination. From this perspective,

  1. the Committee recommends that once human and animal health and safety are assured, the government establish an ongoing mechanism that would stimulate public discussion on economic, trade, social, ethical and other considerations related to drugs and medical devices that are being considered by Health Canada. This mechanism should involve the Canadian Food Inspection Agency where relevant, and may be one outcome of the Health Protection Branch's Transition initiative.

Management Issues within the Health Protection Branch of Health Canada

A. Resolving Differences

In the course of its study, the Committee received testimony, from Health Canada scientists and others, that highlighted management problems within the Health Protection Branch. It was alleged, for example, that scientists were being pressured and coerced, and that managers were refusing to meet with employees. Moreover, there were allegations of gag orders, and stolen and shredded documents. In this regard, the Committee notes the announcement of 12 January 1999 that the Information Commissioner of Canada had found "no improper destruction of records relating to (rBST) by staff of (Health Canada)." The Commissioner's investigation had been undertaken following alleged improper destruction of rBST-related records by BVD officials during the 23-27 October 1998 period.

Several of the Health Canada scientists who appeared before the Committee were so concerned about their future employment that they delayed appearing until they had received assurance that there would be no reprisals. As well, they took the unusual step of swearing an oath before testifying. These concerns are serious, and the Committee re-iterates the point made during their appearance: it wishes to be contacted should they feel they are suffering reprisals related to their appearance, whether in the short or the long term.

The Committee did not study these allegations fully, and thus lacks sufficient information to say definitively to what extent they are accurate. It welcomes, however, the statement of Mr. Dodge, who testified that he regarded the allegations as "extraordinarily serious," and that he was taking steps to get to the bottom of them.

A number of scientists informed the Committee that scientific opinions often differ. Scientists must be able to engage in debate and express differing points of view without suffering reprisals. Indeed, it is perhaps this debate and exchange of opinions that will in part ensure public health and safety, as scientists challenge one another and explore alternative points of view. In her appearance before the Committee, Ms. Jean Szkotnicki, of the Canadian Animal Health Institute, testified that the "… BVD needs to implement a proper and disciplined scientific dispute mechanism." The Committee agrees that such mechanisms are critical, and urges managers at Health Canada to create an environment and mechanisms that will facilitate debate.

Health Canada management recognizes the importance of scientific differences of opinion. Dr. Losos told the Committee that they are very common and are welcomed. He also agreed, however, that differences of opinion have not perhaps always been addressed in the best way. He testified that "… over the years … perhaps in certain units those differences of opinion between scientists were not properly co-ordinated or managed. The (Health Protection Branch) does have dispute resolution mechanisms when it comes to science, but I would say that they have not been used uniformly across the branch in the past. … (T)hey certainly will be because I personally and my senior staff will be strengthening that dispute resolution mechanism from here on in." Mr. Dodge testified that "… good science must have an atmosphere of free discussion and free debate in order to survive."

The Committee would like to review departmental actions taken to resolve the management issues identified in this report, and retains an active interest in changes within Health Canada. For this reason,

  1. the Committee recommends that Health Canada officials appear before the Standing Senate Committee on Agriculture and Forestry no later than June 1999 to provide information about the initiatives undertaken to resolve the management problems identified in this report.

The Committee notes that witnesses testified that some Health Canada officials responded to questions in a manner that, in their opinion, was factually inconsistent with letters, internal memoranda or other documents written by those officials. Since the Committee did not pursue this issue, it cannot comment on whether or not these inconsistencies were intentional.

 

B. The Joint Program Management Advisory Committee

Some Committee members have concerns about the Joint Program Management Advisory Committee, particularly industry input on the Advisory Committee. The Advisory Committee's membership includes senior officials from the Bureau of Veterinary Drugs, representatives of the Canadian Veterinary Medical Association, and representatives of the Canadian Animal Health Institute, an industry association that represents animal drug manufacturers in Canada. The Advisory Committee shares and discusses issues of common interest and importance to the veterinary drugs program.

The Committee received evidence that it was through this Advisory Committee that industry representatives gained routine access to the names of the drug evaluators reviewing their products. This came about despite the objections of evaluators who feared pressure from industry. In the area of health and safety, there must be no pressure, bias or conflict of interest. To ensure public confidence in their food and drugs, Canadians must be confident that drug evaluators, food safety inspectors, and others, are not being pressured; Canadians must know that these professionals are permitted to act solely in the best interests of the Canadian public. The Committee believes that efforts must be taken to ensure that the operations of the Bureau of Veterinary Drugs are not being inappropriately influenced by industry concerns expressed through the Joint Program Management Advisory Committee. To this end, the Committee urges the Minister of Health to review the composition and role of the Advisory Committee with a view to eliminating any undue industry influence.

 

C. Accessing Information

In their appearance before the Committee, several Health Canada scientists noted that the files related to rBST are kept in a locked cabinet, to which only one person has the key. Dr. Chopra told the Committee that "… Dr. Alexander guards all rBST files in the department. Nobody else is allowed to see the rBST files. This is unique to only this file. Every other file is accessible to us in the central registry." Moreover, Dr. Haydon informed the Committee that rBST-related files had been stolen from locked cabinets in her office, which had prompted a full RCMP investigation of the matter; Health Canada officials informed the Committee that the RCMP closed the file. Mr. Dodge told the Committee that, in light of this situation, the department has an obligation to ensure that this does not happen again. He also noted that with extraordinarily sensitive files, of which rBST is one, the normal procedure is to heighten security measures.

The Committee appreciates the difficulty of the department's task in safeguarding public health and safety, and believes that it can best be carried out if departmental scientists have access to all needed information and documents. The Committee is not suggesting that information or documents are deliberately being withheld from scientists, but urges the department to examine whether there is an alternative means by which sensitive information and documents could be safeguarded yet made available to those within the department that need them to do their jobs effectively and efficiently.

 

D. Performance Standards

The Committee wishes to make one final observation about the BVD. Ms. Szkotnicki testified that "… new drug submissions (have moved) from a time frame of 344 days in 1996 to 713 days in September of 1998. … (T)he government's own administrative time frame for review of these types of submissions is 180 days. … The BVD is not meeting its own standards of performance." The Committee hopes that one of the benefits of the changes within the Health Protection Branch will be greater adherence to internal performance standards, while recognizing the imperative of safeguarding health and safety.


Accessing Information

A. Access by the Committee

For this Committee, or any parliamentary committee, to conduct a study as thoroughly as possible, it must have full disclosure of information. To this end, following the first appearance of Health Canada officials, the Committee requested certain information and documents. To the Committee's disappointment, significant amounts of information were missing from the documents initially received from the department. Although more complete documentation was eventually received by the Committee through other means, the Committee is disturbed by the lengths to which it had to go to obtain information from the department. As a result,

  1. the Committee recommends that any federal government department asked for information by a parliamentary committee fulfill that request completely and as expeditiously as possible. Information that the department believes to be proprietary should be presented to committees in camera, with a rationale for maintaining confidentiality.

The Committee re-iterates the importance of providing parliamentary committees with all of the information and documents they require to fulfill their tasks and thereby serve Canadians in the best possible manner. The Committee supports the traditional constitutional powers of parliamentary committees to send for records. It also recognizes, however, that access to proprietary information carries with it an obligation to safeguard confidentiality.

 

B. Access by the Public

Witnesses told the Committee that public confidence in Health Canada is waning. Nevertheless, the Committee believes that Health Canada employees are professionals who fulfill their tasks with commitment and to the very best of their abilities. Canadians must see the department as credible, and the Committee views the Health Protection Branch's Transition initiative as very useful in this regard. It supports, in particular, the extent to which the initiative seeks to involve the public and thereby enhance transparency. The Discussion Paper notes that a guiding principle will be that "Canadians will be consulted. Individuals, other levels of government, communities, health organizations, unions, employees, health professionals, industry representatives, international organizations and others will be given opportunities to participate. The process of transition will be open and accountable to Canadians, including the goals, activities and results." In supporting the need for and benefits of consultation,

  1. the Committee recommends that Health Canada, and in particular the Health Protection Branch, explore means by which ongoing consultation with the public, and information dissemination to it, can continue following the Transition initiative.
  2.  

It is through such consultation and information disclosure that public confidence in the ability of Health Canada to safeguard the health and safety of Canadians will be ensured.


Conclusion

In the course of its study, the Committee has learned a great deal, and respects the opinions of the highly credible individuals and institutions that have presented testimony. It has been made clear to the Committee that the process by which drugs are evaluated and approved in Canada should be examined. The Committee again recognizes, and supports, the Transition initiative of the Health Protection Branch of Health Canada.

As noted earlier, in the next decade Health Canada will examine many more genetically engineered products. In the Committee's view, the approval process must be thorough, transparent and balanced. The process must be thorough to ensure that human and animal health and safety are protected in the short and long term, transparent so that Canadians believe that health and safety are the paramount considerations in drug approvals, and balanced to recognize not only the interests of drug manufacturers and the desire of Canadian producers to have the tools to facilitate competitiveness, but also the overriding imperative of human and animal health and safety within Canada.

Bearing all this in mind, the Committee is confident that the needed changes to the Health Protection Branch will be made. While many of the issues related to rBST have been controversial, the Committee believes that this has resulted in benefits through the identification of broader concerns about the drug approval process and the need for transparency and thorough review.

As Mr. Dodge testified before the Committee, "(t)he job of the department … is to protect the health and safety of Canadians. … Our client is every one of the 30 million Canadians … who eat food, consume drugs, and use toys or other products. … That is our sole job." The Committee believes that its findings and recommendations will assist the department in this task


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