rBST AND THE DRUG APPROVAL PROCESS

Interim Report

The Standing Senate Committee on Agriculture and Forestry 

Chairman : The Honourable Leonard J. Gustafson

Deputy Chairman : The Honourable Eugene F. Whelan, P.C., O.C.

March 1999


MEMBERSHIP

 

The Honourable Leonard J. Gustafson, Chairman
The Honourable Eugene F. Whelan, P.C., O.C., Deputy Chairman

 and

 The Honourable Senators:

Chalifoux, Thelma Robichaud, Fernand, P.C.
Fairbairn, Joyce, P.C. Rossiter, Eileen
*Graham, Alasdair B., P.C. (or Carstairs, Sharon) Sparrow, Herbert
Hays, Daniel Spivak, Mira
*Lynch-Staunton, John, P.C. (or Kinsella, Noel A.) Stratton, Terry
Rivest, Jean-Claude Taylor, Nicholas

 

*Ex Officio Members

 

Note: The Honourable Senators Ghitter, Mahovlich and Milne were members or present at meetings at various stages during the course of this study.

Staff from the Parliamentary Research Branch of the Library of Parliament:

 

Ms. June Dewetering and Mr. Frédéric Forge
Research Officers

 

 Blair Armitage
Clerk of the Committee


ORDER OF REFERENCE

 

Extract from the Journals of the Senate, Thursday, May 14, 1998:

The Honourable Senator Whelan, P.C., moved, seconded by the Honourable Senator Robichaud, P.C. (L’Acadie-Acadia):

THAT the Standing Senate Committee on Agriculture and Forestry be authorized to examine and report on the Recombinant Bovine Growth Hormone (rBST) and its effect on the human and animal health aspects.

After debate,

The question being put on the motion, it was adopted.

 

Paul Bélisle
Clerk of the Senate


TABLE OF CONTENTS

EXECUTIVE SUMMARY

LIST OF RECOMMENDATIONS

LIST OF ABBREVIATIONS

Introduction

The Drug Approval Process

A. The Process
B. The Process and rBST
C. Conclusions Reached

The Evidence on rBST

A. The Safety of rBST for Humans
B. The Safety of rBST for Animals
C. Other Aspects of rBST Use

Management Issues within the Health Protection Branch of Health Canada

A. Resolving Differences
B. The Joint Program Management Advisory Committee
C. Accessing Information
D. Performance Standards

Accessing Information

A. Access by the Committee
B. Access by the Public

Conclusion

APPENDIX 1

THE PRECAUTIONARY PRINCIPLE AND RISK MANAGEMENT DEFINED

A. Precautionary Principle
B. Risk Management

APPENDIX 2

THE CODEX ALIMENTARIUS COMMISSION AND THE JOINT EXPERT COMMITTEE ON FOOD ADDITIVES

APPENDIX 3

ACCESSING INFORMATION

APPENDIX 4

WITNESSES


EXECUTIVE SUMMARY

On 5 May 1998, the Senate of Canada unanimously passed a motion urging the government to defer licensing recombinant bovine somatotropin (rBST) for at least one year and thereafter until the long-term risks to public health are known.

Recombinant bovine somatotropin is a non-therapeutic drug, produced by genetic engineering, which can increase milk production in dairy cattle. For more than a decade, the long-term effect of rBST on animals and on people has been the subject of controversy. In 1990, Health Canada received a submission from a manufacturer that wanted to market rBST in Canada. When the Standing Senate Committee on Agriculture and Forestry began its public hearings on 4 June 1998, Health Canada had not completed its review of rBST. During its study of the effects of rBST on people and on animals, the Committee heard from Monsanto Canada; Health Canada scientists and officials; scientists from other countries; dairy producers and processors; and public interest groups. As well, more than 400 Canadians wrote to the Committee.

The Committee received testimony about Canada's drug approval process, both generally and with respect to rBST. In the opinion of some witnesses, Monsanto's rBST submission failed to meet the standard data requirements for any new drug submission. Moreover, in the opinion of Health Canada drug evaluators in the Bureau of Veterinary Drugs, not all animal and human safety aspects were adequately addressed in the department’s evaluation of the submission.

On 14 January 1999, Health Canada announced that it will not approve rBST for sale in Canada, citing the findings of two expert advisory panels formed to evaluate rBST. At the same time, Monsanto announced that it intends to continue to seek approval of the drug. Believing that additional studies are needed, the Committee recommends that no approval for rBST be granted in future until long-term studies on human health are submitted and reviewed. It also recommends that Health Canada ask for a previously-requested study on animal safety and efficacy.

Many witnesses told the Committee of their concerns about the drug approval process in general. They testified that some Canadians believe that Health Canada views industry, rather than the Canadian public, as the department's client. Viewing these concerns as serious, the Committee makes a number of recommendations to enhance public confidence. The Committee recommends that the Government conduct an evaluation of the drug approval process, and that Health Canada explore means for ongoing consultation with the public. Also recommended is the creation of a mechanism for ongoing public discussion of the economic, trade, social, ethical and other considerations related to drugs and medical devices.

The possibility of industry influence on the drug approval process and conflicts of interest were noted by a number of witnesses, as was the potential impact of decisions made by international organizations. Witnesses questioned the participation by industry in the Bureau of Veterinary Drug's Joint Program Management Advisory Committee, and industry representation at the Codex Alimentarius Commission and the Joint Expert Committee on Food Additives. The Committee believes that Canadians must be assured that decisions about drug approvals are made domestically. It recommends that Health Canada evaluators make these decisions, while acknowledging that the opinions of external advisory panels and international bodies can complement evaluators’ reviews. To reinforce confidence in the drug approval process, the Committee also recommends full adherence to Health Canada's conflict of interest guidelines in the appointment of members to external panels and as Canadian representatives on international bodies.

The Committee also heard testimony about management problems in the department and suggestions of pressure, coercion, document theft and gag orders. Feeling that the best decisions are made in an atmosphere of trust, the Committee recommends that Health Canada officials appear before the Committee to provide information about steps they have taken to resolve the problems.

Finally, the Committee experienced difficulties in receiving information from Health Canada. Believing that parliamentary committees require complete information to carry out their responsibility to Canadians, the Committee recommends that federal departments fulfill information requests from committees completely and as expeditiously as possible, with proprietary information presented to committees in camera.

The Committee intends to hold additional hearings to receive testimony from the expert advisory panels which evaluated rBST and others who have expressed ongoing concerns.


LIST OF RECOMMENDATIONS

 

  1. The Committee recommends that Health Canada ensure full adherence to its conflict of interest guidelines and, in cases of perceived conflict of interest, publicly declare its reasons for accepting the appointment of any individuals for whom a conflict is perceived. (page 10).

  2. The Committee recommends that decisions about the safety of drugs for humans, and the safety and efficacy of drugs for animals, be left with Health Canada evaluators (page 11).

  3. The Committee, having heard the suggestion of some witnesses, recommends that the government conduct an evaluation of Health Canada's drug approval process to ensure that it fully safeguards human and animal health and safety. This evaluation should be undertaken by independent experts, either in conjunction with any follow-up activities of the Auditor General of Canada regarding the Health Protection Branch or subject to review by the Auditor General (page 13).

  4. 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 (page 17).

  5. 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 (page 18).

  6. 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 (page 21).

  7. 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 (page 22).

  8. 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 (page 24).

  9. 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 (page 24).

LIST OF ABBREVIATIONS

BVD: Bureau of Veterinary Drugs
CNS: Central Nervous System
ESC: Experimental Studies Certificate
EU: European Union
FAO: Food and Agriculture Organization
FDA: Food and Drug Administration
HSD: Human Safety Division
IGF-1: Insulin-like Growth Factor 1
IND: Investigational New Drugs
JECFA: Joint Expert Committee on Food Additives
NDS: New Drug Submission
NOC: Notice of Compliance
rBGH: recombinant bovine growth hormone
rBST: recombinant bovine somatotropin
WHO: World Health Organization
WTO: World Trade Organization

Introduction

On 5 May 1998 the Senate of Canada passed a unanimous motion, introduced by the Honourable Senator Eugene F. Whelan, P.C., O.C. and seconded by the Honourable Senator Céline Hervieux-Payette, P.C., urging the government "to defer licensing the use of (rBST) … for at least one year, and thereafter until such time as scientific studies have been designed, tested and completed whose conclusions enable the Government to either precisely identify for Canadians the long-term risks to public health or, in the alternative, to publicly assure them that the use of this growth hormone will not affect their individual health." Following this motion, on 4 June 1998 the Standing Senate Committee on Agriculture and Forestry initiated public hearings on the health and safety effects of rBST use on humans and on animals. This study is not the first parliamentary examination of rBST. In 1994, the House of Commons Standing Committee on Agriculture held hearings on this issue, and recommended that "in order to allow a period of adjustment for the dairy industry and address the need for more public information about (rBST), ... the federal government legislate a one-year moratorium on the use of bovine somatotropin in Canada." It also recommended that "the period of the one-year moratorium be used to review in greater detail the impact of synthetic bST on: the costs and benefits for the Canadian dairy industry; animal health, including the stress placed on target animals; animal genetics; and U.S. consumer reactions and any outstanding human health issues."

Recombinant bovine somatotropin (rBST), or recombinant bovine growth hormone (rBGH) as it is also known, has been the subject of controversy, in Canada and elsewhere, for more than a decade. Health Canada has not approved the sale or use of rBST in Canada. A non-therapeutic veterinary drug produced by genetic engineering, this hormone can increase milk production by up to 10-15% when administered to lactating cows. According to a number of sources, including presentations made to the Standing Senate Committee on Agriculture and Forestry, the potential long-term effects of the hormone on animals to which it has been administered, and on humans who have consumed the products of these animals, are disputed.

In its study, the Standing Senate Committee on Agriculture and Forestry heard from officials of Monsanto Canada, a drug manufacturer that wants to market rBST in Canada; Health Canada scientists and senior managers; scientists from the United States and Australia; dairy producers; dairy processors; and public interest groups in various countries. As well, more than 400 Canadians wrote to express their concern about rBST. This report summarizes evidence received by the Committee, and makes recommendations in a number of areas. While the Committee notes Health Canada's 14 January 1999 announcement that it will not approve rBST for sale in Canada, the Committee does make recommendations specific to rBST; these recommendations could be important in light of Monsanto's intention to continue to seek approval. The Committee also makes recommendations related to the drug approval process in general, however, as its study has highlighted concerns with the approval process.

The Committee believes that its hearings and this report will clarify some of the issues about rBST use in Canada as well as internationally, and about the drug approval process. In light of information brought to public attention by the Canadian Senate, two United States Senators, several public interest groups and others are calling on the U.S. Food and Drug Administration to revisit its findings on rBST. Moreover, the Committee hopes that its recommendations will aid Health Canada in reinforcing the confidence of the public and of industry in its drug approval process.


The Drug Approval Process

A. The Process

Health Canada alone has responsibility for approving the sale of any new drug in Canada, including rBST. The department administers the Food and Drugs Act and its Regulations, which control therapeutic and non-therapeutic drugs for humans and animals. Regulations prohibit anyone from selling a new drug or advertising one for sale unless several conditions have been met. Before a new drug can be used, its manufacturer must have filed a New Drug Submission (NDS) and Health Canada must have issued a Notice of Compliance (NOC). Regulations require an evaluation of the safety, purity, effectiveness, potency and stability of the drug. As well, they require the manufacturer to submit scientific data that demonstrate the drug is safe and effective when used in accordance with the directions on the label. Section C.08.002.(2) of the Regulations calls for, among other things, detailed reports of the tests made to establish the safety of the new drug for the purpose and under the conditions of use recommended; Regulations do not, however, specify the type of studies to be undertaken. Health Canada's rBST internal review team has noted that the standard requirement for any new drug submission is a data package that includes acute, sub-acute and chronic studies, two-generation reproduction studies, and teratology studies. In the case of a drug for food-producing animals, residue studies are also required to support recommended periods for withdrawal of the drug before milk or meat is marketed.

Health Canada is required by law to consider each drug submission, and must review the information and scientific data provided by the manufacturer. In this review, only scientific considerations are relevant. If the NDS complies with all the relevant requirements, Health Canada must issue a Notice of Compliance. If, however, the submission does not meet the requirements, Health Canada must so notify the manufacturer and give it the opportunity to add scientific information or data. Once the NDS is complete and its contents are satisfactory, Health Canada issues a Notice of Compliance. In reviewing veterinary drugs, evaluators must be assured that all safety and efficacy issues have been addressed before the NOC is granted. Conditional NOCs, allowing the manufacturer to demonstrate safety through a post-approval monitoring program, or any other condition attached to the NOC, are not permitted for veterinary drugs.

The Bureau of Veterinary Drugs (BVD) within the Food Directorate of the Health Protection Branch is responsible for the implementation of that part of the Food and Drugs Act and its regulations dealing with veterinary drugs. Within the BVD, the Human Safety Division (HSD) evaluates the human safety aspects of all veterinary drugs for food-producing animals; the Pharmaceutical Assessment Division, formerly the Central Nervous System (CNS)/Endocrine/Antiparasitic Division, evaluates the target animal safety and efficacy.

 

B. The Process and rBST

Since 1984, Monsanto, Elanco and Cyanamid have made requests to Health Canada regarding rBST-based products. In particular, they have requested Experimental Studies Certificates (ESC) for researchers to carry out specific projects and Investigational New Drugs (IND) for investigators to conduct clinical evaluations, and have filed New Drug Submissions (NDS) in order to market their product. In October 1985, Health Canada issued the first Experimental Studies Certificate for an rBST product, concluding that milk from animals to which rBST had been administered posed no human health hazard. In 1986 the department told manufacturers that meat from the experimental cows could be sold for human consumption with no withdrawal period for drug residues.

Prior to Health Canada's 14 January 1999 announcement, the only rBST submission under review at Health Canada was for Nutrilac; Monsanto Canada, the manufacturer, had filed an NDS in February 1990. In March 1988, Elanco Canada submitted an NDS for its rBST-based product. At Elanco’s request, however, the application was put on hold in May 1996, pending the outcome of Monsanto’s submission.

On 12 March 1990, 21 days after Monsanto had filed its New Drug Submission, the Chief of the Human Safety Division wrote to the manufacturer indicating that it had met all human safety requirements. In 1995, however, the CNS/Endocrine/Antiparasitic Division (now the Pharmaceutical Assessment Division) three times refused to sign off on the product, citing inadequate evidence demonstrating its efficacy and animal safety. Drug evaluators cited potential risks to cows, including mastitis, reproductive problems and birth defects. They also concluded that the manufacturer had failed to demonstrate that the product increased milk production, and questioned the design of the submission's studies.

In September 1996, five Health Canada officials met with two officials of Monsanto Canada and three officials of Monsanto U.S. to establish commitments and timelines for the approval of rBST. They agreed, among other things, that one BVD reviewer would be the principal reviewer, working full-time on the evaluation, assisted by a special BVD advisory committee. By August 1997, senior managers within the Health Protection Branch expected that issues of animal safety and efficacy would be resolved and that the review would be completed by the fall of that year. While the department has no legal authority to delay issuing an NOC once a review is completed, it was decided, with the concurrence of Monsanto officials, to delay approving rBST until human safety issues had been evaluated at a February 1998 meeting of the Joint Expert Committee on Food Additives (JECFA). The JECFA is a scientific advisory body to the Codex Alimentarius Commission, an international food standards-setting body, established in 1962 by the World Health Organization and Food and Agriculture Organization of the United Nations.

Because BVD evaluators expressed concerns that not all target species and human safety aspects were adequately addressed in the submission evaluation, an internal review team was established by the Health Protection Branch in January 1998. The team included two scientists from the Bureau of Veterinary Drugs, one scientist from the Bureau of Chemical Safety, and one scientist from the Therapeutic Products Directorate. Its mandate was to review the data on human safety and determine whether there were procedural and scientific gaps. The internal review team produced two reports: the first report, the Gaps Analysis Report dated 21 April 1998, was signed by all team members; the second report, the Internal rBST Review report dated 10 June 1998, was signed by the two Health Canada scientists who are not members of the Bureau of Veterinary Drugs.

At the same time, the Health Protection Branch initiated third-party evaluations to be included in the decision-making process. Health Canada officials told the Committee that this kind of evaluation is a common procedure. Two expert advisory panels -- one under the direction of the Canadian Veterinary Medical Association for the animal health and efficacy aspects and the other under the Royal College of Physicians and Surgeons of Canada for the human health aspect -- were established to evaluate rBST. Health Canada officials told the Committee that these two organizations were chosen to oversee the expert advisory panels because of their reputation for expertise, eminence and integrity.

On 7 December 1998, Health Canada announced that a decision to approve rBST would be made only after the Codex Alimentarius Commission met in Rome in June 1999. It also indicated that, depending on the findings of these expert advisory panels, further long-term studies might be required. On 14 January 1999, Health Canada announced its decision not to approve rBST, and noted that this decision was based on "more than nine years of comprehensive review of the effects of (rBST) on animal and human safety, and consideration of the … findings by two independent external committees." The Committee intends to hold additional hearings on the issue of rBST, and to receive testimony from these expert advisory panels.

The panel evaluating human health found no significant risk to human safety associated with the consumption of products from animals to which rBST had been administered. It also concluded "that (rBST) poses no carcinogenic risk, that (rBST)-induced IGF-1 … is insignificant when compared with naturally-occurring IGF-1, that there is little likelihood of increased antibiotic resistance, and only a small potential for allergic reactions." The panel, however, also indicated that, in its opinion, Monsanto "should be asked to repeat the 90-day toxicity studies of (rBST) and to explore whether or not there is a real risk of hypersensitivity reactions occurring at 0.1mg/kg/day."

The panel assessing the implications of rBST on animal health, however, found "an increased risk of mastitis of up to 25%, of infertility by 18%, and of lameness by up to 50%. These increased risks and overall reduced body condition lead to a 20-25% increased risk of culling from the herd."

Concerns have been raised about apparent conflicts of interest in these two expert advisory panels. For example, in its statement to the Committee, the Council of Canadians noted that the panel formed by the Royal College of Physicians and Surgeons "… includes at least one member who has been a paid consultant of Monsanto since 1993." Nevertheless, it should be noted that members of both panels completed conflict of interest declaration forms, which were reviewed by Health Canada management and legal services. Health Canada officials indicated to the Committee that conflict of interest issues were investigated and all questions were answered.

The Committee is concerned about the effect of alleged conflicts of interest, particularly on public confidence in the integrity of the drug approval process. The point that public confidence must be reinforced is made repeatedly throughout this report. For this reason,

  1. the Committee recommends that Health Canada ensure full adherence to its conflict of interest guidelines and, in cases of perceived conflict of interest, publicly declare its reasons for accepting the appointment of any individuals for whom a conflict is perceived.

Members of the Health Canada internal review team told the Committee that they found procedural gaps in the BVD evaluation. Both the Gaps Analysis Report and the subsequent Internal rBST Review report detailed ways in which the rBST submission was atypically handled. They found that:

In fulfilling their legal duty, drug evaluators at Health Canada must undertake the review of any New Drug Submission with due diligence. According to Dr. Michelle Brill-Edwards, of the Alliance for Public Accountability and a former senior physician responsible for prescription drug approvals within the Health Protection Branch, an NOC for human safety is a legal commitment that Health Canada has performed its role with due diligence, has examined the submission in-depth and has no further questions regarding human safety. Dr. Brill-Edwards believes that due diligence has not been observed with respect to rBST, since a letter was sent to the manufacturer 21 days after its submission without evidence that the product had been reviewed for human health hazards. In her view, the two expert advisory panels established by the Health Protection Branch can be used to oppose the decisions of the department’s own scientists applying due diligence. The Committee believes that the attitude of the BVD evaluators, who expressed concerns about the validity of the data package and refused an NOC for animal safety and efficacy, is the correct approach.

As indicated to the Committee by Dr. Thea Mueller, a member of the Health Canada internal review team from the Therapeutic Products Directorate, "scientific issues … have become intertwined with the internal conflict that the rBST submissions have generated within the (BVD)." Indeed, Dr. Shiv Chopra, another member of the internal review team and a BVD evaluator, told the Committee that he and some other drug evaluators had been pressured and coerced to pass drugs of questionable safety, including rBST. Dr. Margaret Haydon, a former rBST drug evaluator, testified that files were stolen from her locked cabinet when she was one of the rBST evaluators. Issues related to the working environment within the BVD are addressed more fully later in the report.

In light of these procedural deficiencies, and the atmosphere with respect to the process, the Committee is concerned that Canadians may lose confidence in the health protection regulatory process, which is considered one of the best in the world. While the Committee recognizes that the decisions, opinions and analysis of external advisory panels and international bodies can complement the internal review at Health Canada, it believes that they must not replace the evaluation process within the department. Final responsibility and accountability must rest with Health Canada. The Committee cannot emphasize enough the importance of there being public confidence in the drug approval process and in food safety. From this perspective,

  1. the Committee recommends that decisions about the safety of drugs for humans, and the safety and efficacy of drugs for animals, be left with Health Canada evaluators.

 

C. Conclusions Reached

While the evaluation and approval of rBST is the issue currently under study, the Committee believes that there are more fundamental questions about how the drug approval process is, or is not, working. These concerns must be resolved at the earliest opportunity. A number of witnesses informed the Committee that, in the next decade, Health Canada will likely be asked to approve significantly more genetically engineered products. In fact, Dr. Joseph Losos, Assistant Deputy Minister of the Health Protection Branch of Health Canada, told the Committee that, over the next decade, increases of 200% to 500% in biotechnologically engineered products are predicted in some fields. Thus, any problems with the process must be resolved now.

The Committee is aware of the Health Protection Branch's Transition initiative. Health Canada's July 1998 Discussion Paper Health Protection for the 21st Century: Renewing the Federal Health Protection Program notes that "over the next two to three years, the H(ealth) P(rotection) B(ranch) will go through a process of review, consultation and renewal of our health protection activities in order to find new and better ways to protect the health of Canadians into the next century." The Science Advisory Board, made up of independent scientists, health professionals, consumer advocates and others with public health expertise, has been established to provide the Minister of Health with independent scientific, technical and policy advice.

Some Committee members are concerned about the submission of tests and data by the manufacturer of a new drug. One problem in this regard is public perception. In particular, there is a danger that public confidence is diminished if the manufacturer of a drug undertakes the testing of that drug. Although this procedure may be of concern, it is not new. The Committee recognizes that individuals and entities other than Health Canada scientists are capable of undertaking this task and believes that a mechanism must be found to give Canadians confidence that the client of the Health Protection Branch is the public, and not the drug manufacturer. The Committee believes that Health Canada drug evaluators must be permitted to undertake their task without perceived pressure from industry or from Health Canada management for them to approve drugs of questionable safety. While Health Canada management has an additional responsibility to ensure that drug evaluations are completed in a timely fashion, its first duty must be to ensure safety and to provide an environment in which evaluators can apply due diligence in fulfilling their tasks.

Health Canada officials repeatedly told the Committee that the Canadian public is, and always will be, the client. Nevertheless, the Canadian Health Coalition testified that "(a) growing body of evidence suggests that senior managers in Health Canada have implemented a biased mandate which serves the interests of industry instead of the public interest. All the evidence shows that industry is the client …" Certainly, greater transparency, public consultation and public input would aid in providing Canadians with a greater assurance that the Branch is there to protect them. In the words of the July 1998 Discussion Paper, "(i)f industry takes on more responsibility for product safety and standards, Canadians want assurance that public health interests will continue to be the first priority." The Committee strongly agrees.

The Committee also supports a question raised in the Discussion Paper that has relevance in this regard: "How do we ensure independence and effectiveness when we work in collaboration with private-sector scientists and facilities?" While the Committee understands the fiscal imperatives that have led to reduced research funding within Canada, mechanisms must be found to ensure that independence exists, both in fact and in perception. The Committee also notes the concerns of some witnesses with respect to cost recovery, whereby industry finances 70% of the cost of drug approvals. This, too, may lead the public to question whether industry or the Canadian public is the client of the Health Protection Branch.

Of some note in this regard is the testimony of Dr. Mueller, who told the Committee that "… it is a fact (that) … in the regulatory field … we place quite a large reliance, or heavy reliance, on data generated by the manufacturer. … (T)here are checks and balances that we can use. We can ask the company to design the studies in such a way that we can determine, or have a fair level of confidence, that the data (are) a true reflection of the situation." The Committee believes that these checks and balances must be used at every opportunity.

The Committee is cognizant of the Science Advisory Board's intention to study the drug review process. The Board is currently obtaining views from those with an interest in the process, particularly with respect to: the timeliness, efficiency and effectiveness of the process; whether the public has fair, reasonable and timely access to information about drug submissions and about drug safety and efficacy; whether Health Canada should continue to pursue harmonization and cooperation with foreign governments' regulatory authorities for the drug review process; the relationship between charging fees for drug review and influence on the drug review process; and the principles that should guide the drug review process. While such a study is welcome, the Committee believes that more must be done.

Moreover, the Committee is aware of the Auditor General's report of May 1995 on the Management of the Change Initiative at the Health Protection Branch and of the follow-up report of December 1998. The latter report stated that "(i)n most areas, additional work remains to be done by the Health Protection Branch to fully address … concerns." The Committee believes that an evaluation of the drug approval process could complement any follow-up activities undertaken by the Auditor General, and that the evaluation might occur after any recommendations made by the Science Advisory Board have been implemented. As a result, and notwithstanding the study of the drug review process being undertaken by the Science Advisory Board,

  1. the Committee, having heard the suggestion of some witnesses, recommends that the government conduct an evaluation of Health Canada's drug approval process to ensure that it fully safeguards human and animal health and safety. This evaluation should be undertaken by independent experts, either in conjunction with any follow-up activities of the Auditor General of Canada regarding the Health Protection Branch or subject to review by the Auditor General.

The Committee retains an interest in this, and other, concerns identified in the report, and will continue to monitor this issue.

Finally, the Committee wishes to note the concern of some witnesses that the drug approval process contain an element of predictability, in order that drug manufacturers continue to seek approval in Canada and thereby provide Canadians with the same drugs that are available in other countries. Mr. David Dodge, Health Canada's Deputy Minister, indicated that if the process is compromised in Canada, or if developers of new drugs believe this to be the case, they will not attempt to register their products here. In that case, Canadian consumers and farmers would lack access to products available elsewhere.


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