Vol. 134, No. 32 — August 5, 2000

Regulations Amending the Food and Drug Regulations (1211 — Schedule F Additions)

Statutory Authority

Food and Drugs Act

Sponsoring Department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

Description

The Therapeutic Products Programme (TPP) of Health Canada intends to update Schedule F to the Food and Drug Regulations of the Food and Drugs Act by adding 11 substances to Part I of Schedule F.

Schedule F is a list of substances, the sale of which are controlled specifically under sections C.01.041 to C.01.046 of the Food and Drug Regulations. Part I of Schedule F lists substances which require a prescription for both human and veterinary use. Part II of Schedule F lists substances which require a prescription for human use, but do not require a prescription for veterinary use if so labelled or if in a form unsuitable for human use. The review and introduction of new drugs onto the Canadian market necessitate periodic revisions to Schedule F.

The Therapeutic Products Programme's Drug Schedule Status Subcommittee reviews the status of chemical entities proposed for marketing. A decision regarding the necessity for prescription versus non prescription status was made for each of the substances listed in this proposed amendment on the basis of established and publicly available criteria. These criteria include, but are not limited to, concerns related to toxicity, pharmacologic properties and therapeutic applications.

It is proposed that the following 11 substances be added to Part I of Schedule F:

1. Daclizumab — an immunosuppressive — a recombinant DNA-derived humanized monoclonal antibody indicated as an adjunct for the prophylaxis of acute organ rejection in renal transplant patients.

2. Marbofloxacin and its salts and derivatives — an antibacterial — a synthetic broad spectrum antibacterial indicated for the treatment of urinary tract infections in dogs, and for the treatment of skin and soft tissue infections in dogs.

3. Melanoma therapeutic vaccine — an immunostimulant and adjuvant — a combination of Melanoma Lysate, an antigenic component, and Detox, an immunological adjuvant, indicated for the treatment of Stage IV malignant melanoma.

4. Oseltamivir and its salts — an antiviral — an inhibitor of the influenza virus neuranimidase indicated for the treatment of uncomplicated illness due to influenza virus in adults.

5. Poractant alfa — a lung surfactant (porcine) — a sterile non-pyrogenic pulmonary surfactant prepared from porcine lungs and administered intratracheally, indicated for the treatment of Respiratory Distress Syndrome (RDS) in premature infants.

6. Risedronic acid and its salts — a bone metabolism regulator — a bisphosphonate in the form of hemi-pentahydrate, that inhibits osteoclast bone resorption and modulates bone metabolism, indicated for Paget's disease of the bone.

7. Rofecoxib — an anti-inflammatory analgesic — a nonsteroidal anti-inflammatory analgesic indicated for the treatment of the signs and symptoms of osteoarthritis and primary dysmenorrhea and relief of pain in adults.

8. Telmisartan and its salts and derivatives — an angiotensin II AT1 receptor blocker indicated for treatment of mild to moderate essential hyptertension.

9. Temozolomide and its salts — an antineoplastic — an alkylating antineoplastic indicated for the treatment of adults with recurring or progressing glioblastoma multiforme or anaplastic astrocytoma after standard therapy.

10. Tirofiban and its salts and derivatives — a platelet aggregation inhibitor — a reversible antagonist of fibrinogen which binds to the GP IIb/IIIa receptor, indicated for unstable angina or non-Q wave myocardial infarction. Used in combination with heparin and ASA.

11. Trastuzumab — an antineoplastic — a recombinant DNA-derived humanized monoclonal antibody indicated for metastatic breast cancer whose tumours overexpress the HER2 protein.

Alternatives

This recommended degree of regulatory control coincides with the risk factors associated with each specific substance. The review of the information filed by the sponsor of these drugs has determined that prescription status is required at this time. Advice from a medical practitioner is necessary to ensure that consumers receive adequate risk/benefit information before taking the medication.

Any alternatives to the degree of regulatory control recommended in this regulatory initiative would need to be established through additional scientific information and clinical experience.

No other alternatives were considered.

Benefits and Costs

The amendment would impact on the following sectors:

Public

Prescription access to the drugs affected by Schedule 1211 would benefit Canadians by decreasing the opportunities for improper use, and by ensuring professional guidance and care.

Pharmaceutical Industry

The classification of these drugs as prescription products would limit their sale subject to the provision of the advice of a practitioner, thereby reducing misuse and decreasing liability to the manufacturer.

Health Insurance Plans

These drugs, when assigned prescription status, may be covered by both provincial and private health care plans.

Provincial Health Care Services

The provinces may incur costs to cover physicians' fees for services. However, the guidance and care provided by the physicians would reduce the need for health care services that may result from improper use of the drugs. The overall additional costs for health care services should therefore be minimal.

Consultation

The manufacturers affected by this proposed amendment were informed of the intent to recommend these substances for inclusion on Part I of Schedule F at the time of market approval of the drugs.

A letter to the stakeholders dated March 7, 2000, was provided by direct mail to the Pharmaceutical Issues Committee, Deans of Pharmacy, Registrars of Medicine, Registrars of Pharmacy, Provincial Deputy Ministers of Health, Health and Trade Associations, Regional Directors of the Health Protection Branch (HPB) of Health Canada, Health Industries Branch of Industry Canada, Director Generals of Food and Environmental Health and Food Operations, Directorates of Laboratory Centre for Disease Control, and the Acting Director of Regulatory Affairs of Agriculture and Agri-Food Canada, with a 30-day comment period. This initiative was also posted on the Therapeutic Products Programme Web site: http://www.hc-sc.gc.ca/hpb-dgps/therapeut/zfiles/ english/schedule/earlycon/sch-1211_e.pdf. Two comments were received regarding the proposed amendment in the letter to the stakeholders; the stakeholders had no objections to the regulatory proposal.

A 30-day comment period will be provided upon prepublication in the Canada Gazette, Part I.

Compliance and Enforcement

This amendment would not alter existing compliance mechanisms under the provisions of the Food and Drugs Act and Regulations enforced by the Therapeutic Products Programme Inspectors.

Contact

Kiran Nath, Policy Division, Bureau of Policy and Coordination, Therapeutic Products Programme, Holland Cross, Tower B, 2nd Floor, 1600 Scott Street, Address Locator 3102C5, Ottawa Ontario K1A 1B6, (613) 957-6451 (Telephone), (613) 941-6458 (Facsimile), kiran_nath@hc-sc.gc.ca (Electronic mail).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subsection 30(1) of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1211 — Schedule F Additions).

Interested persons may make representations with respect to the proposed Regulations within 30 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Kiran Nath, Therapeutic Products Programme, Department of Health, Address Locator No. 3102C5, 2^nd Floor, Tower B, 1600 Scott Street, Ottawa, Ontario K1A 1B6. (Fax: (613) 941-6458; E-mail: kiran_nath@hc-sc.gc.ca)

The representations should stipulate those parts of the representations that should not be disclosed pursuant to the Access to Information Act and, in particular, pursuant to sections 19 and 20 of that Act, the reason why those parts should not be disclosed and the period during which they should remain undisclosed. The representations should also stipulate those parts of the representations for which there is consent to disclosure pursuant to the Access to Information Act.

Ottawa, July 27, 2000

MARC O'SULLIVAN
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1211 — SCHEDULE F ADDITIONS)

AMENDMENT

1. Part I of Schedule F to the Food and Drug Regulations (see footnote 1) is amended by adding the following in alphabetical order:

Daclizumab
Daclizumab

Marbofloxacin and its salts and derivatives
Marbofloxacine, ses sels et dérivés

Melanoma therapeutic vaccine
Vaccin thérapeutique contre le mélanome

Oseltamivir and its salts
Oséltamivir et ses sels

Poractant alfa
Poractant alfa

Risedronic acid and its salts
Acide risédronique et ses sels

Rofecoxib
Rofécoxib

Telmisartan and its salts and derivatives
Telmisartan, ses sels et dérivés

Temozolomide and its salts
Témozolomide et ses sels

Tirofiban and its salts and derivatives
Tirofiban, ses sels et dérivés

Trastuzumab
Trastuzumab

COMING INTO FORCE

2. These Regulations come into force on the day on which they are registered.

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Regulations Repealing the Country Elevator Agents and Managers Hours of Work Regulations, 1979

Statutory Authority

Canada Labour Code

Sponsoring Department

Department of Human Resources Development

REGULATORY IMPACT ANALYSIS STATEMENT

Description

The Country Elevator Agents and Managers Hours of Work Regulations, 1979 (the Regulations), establish a standard and overtime hours of work regime for some 2 700 country elevator agents and managers who work throughout the four Canadian western provinces. The Regulations stipulate that for 32 weeks of the year, agents and managers at country grain elevators will work a standard 8-hour day and 40-hour week before overtime, with a maximum work week of 48 hours. For the remaining 20 weeks, which in practice are split into two periods of 10 weeks each, which encompass the planting and harvest seasons, these employees work a 48-hour week before becoming entitled to overtime. The maximum weekly hours of work are 60. Overtime during these 20 weeks is banked and is to be taken as time off with pay some time between November 1 and April 13.

In response to an application of the Grain Services Union, calling for the repeal of these Regulations, the Minister of Labour appointed, in September 1997, a Commissioner, Mr. Stephen Kelleher, Q.C., to investigate the situation of employees of country grain elevators in Western Canada. After holding public hearings and receiving numerous written submissions, the Commissioner reported his findings and recommendations on January 26, 1998. He recommended that the Regulations be repealed and that the general hours of work provisions under Part III of the Canada Labour Code (the Code) apply. The report and the recommendations were accepted, and on July 10, 1998, the Minister announced that these Regulations would be repealed January 31, 2001.

Alternatives

The other alternative would have been to retain the Regulations in their present form.

The Commissioner found that the business patterns and working conditions in grain elevators have changed dramatically since the Regulations were developed in 1979. There has been a reduction of 50 percent in the number of country grain elevators. Country elevators have become large, technologically innovative high-throughput facilities. The country elevator agent and manager has less physical work and operates more as a commodities dealer and a retailer of all manner of agricultural products. There have been significant changes to the flow of grain; most is now being shipped year-round through ice-free western ports. Many grain deliveries now go to end users who want just-in-time delivery. This results in a more constant flow of grain through country elevators, eliminating or reducing the busy/slack periods occasioned by the planting and harvesting cycle.

The Commissioner concluded that the repeal of the Regulations would not in any way be detrimental to the grain-handling industry. The hours of work provisions found in the Code contain sufficient flexibility to ensure the availability of workers when needed. Keeping the Regulations would result in a fundamental unfairness for one group of employees to be treated differently from other employees in the federal jurisdiction. There are many employees in other federally regulated or provincially regulated occupations where special arrangements have been made and which do not contemplate a work year of 2 240 hours without overtime.

Benefits and Costs

The Grain Services Union characterized the Regulations as obliging country elevator agents and managers to provide 160 hours of unpaid overtime to grain companies. The repeal of the Regulations means that these employees will now receive adequate compensation for the work they accomplish.

The Western Grain Elevator Association (the Association) argued that the repeal of the Regulations would lead to higher costs. Since virtually all managers work 2 240 hours, elevator companies would have to compensate them for the additional 160 hours at time and one-half. This would add approximately 12 percent to their salaries. It would cost the industry some $10,000,000 per year. The Association speculated that this could lead to closing marginal operations. Since the grain prices have not kept up with the operation costs, it would also lead to higher charges to producers. It was felt that the economics of operating with higher costs could also lead to seasonal layoffs of elevator employees.

The Association also pointed out the collective bargaining leverage that would be accorded to the Grain Services Union if the Regulations were repealed. If the employer seeks concessions in collective bargaining to help pay for the high cost of repealing the Regulations, that will lead to possible strike action.

The Commissioner considered their arguments but concluded that the repeal of these Regulations would not be seriously detrimental to the operations of the industrial establishments. On July 10, 1998, the Minister of Labour announced that the Regulations would be repealed January 31, 2001. By then, all companies would have had an opportunity to negotiate adjustments as part of the normal collective bargaining process.

Consultation

There have been extensive consultations with stakeholders on the issues. In the course of his review of the Regulations in 1997, the Commissioner consulted with a wide range of employer and union representatives.

Public hearings were conducted in Calgary, Winnipeg, Regina and Saskatoon on November 14, 17, 18 and 19, 1997, respectively. Written submissions were presented by the Grain Services Union and the Western Grain Elevator Association. In addition, submissions were filed by Wild Rose Agricultural Producers, Saskatchewan Canola Growers Association, Saskatchewan Chamber of Commerce, Western Canadian Wheat Growers Association, National Farmers' Union, the Canadian Grain Commission, Alberta Grain Commission, Manitoba Corn Growers Association Inc., Flax Growers Western Canada and Keystone Agriculture Producers. Letters and oral submissions from individual producers and individual employees of grain elevators were also received.

The Grain Services Union argued that the Regulations should be repealed. It characterized the Regulations as providing 160 hours of unpaid overtime to grain companies. It also argued that technological and business changes have led to different work patterns. It stated that the business of grain elevators is no longer concentrated in the planting and harvesting season. For example, the month of July, which is not covered by the Regulations, is the busiest month for grain receipt. It also indicated that country elevator agents and managers should be treated the same as other workers subject to Part III of the Code. The submissions received from individual elevator managers were to the same effect.

The Western Grain Elevator Association's position is that the regulations should be retained because of the seasonal nature of the business. The Association stated that elevators are busiest at seeding and harvest time, and that producers usually have only one opportunity to seed or harvest. The elevator staff must provide service when that service is needed by them.

The position of producer organizations and the vast majority of individual producers was that the Regulations should be retained. They emphasized the difficult environment in which producers operate and the lack of capacity for increased costs or decreased services.

The Commissioner recognized that western grain producers operate in a difficult environment, but that it does not mean that the Regulations should be retained. The Commissioner concluded that the repeal of the Regulations could take place after new collective agreements have been negotiated for all agents and managers covered by these Regulations. It was considered that the hours of work provisions found in the Code contain sufficient flexibility to ensure the availability of workers when needed. To facilitate the transition, the Commissioner recommended that a lapse of time be given to the grain elevator companies and the unions to adjust before the hours of work provisions of the Code apply. The Minister of Labour accepted the recommendation, and on July 10, 1998, the Minister announced that the Regulations would be repealed January 31, 2001.

Compliance and Enforcement

When the Minister of Labour announced, in July 1998, that the Regulations would be repealed January 31, 2001, he indicated that by that time all companies would have had an opportunity to negotiate adjustments through the normal collective bargaining process before the hours of work provisions of the Code apply to the country elevator agents and managers. The Minister also stated that the Federal Mediation and Conciliation Services would be available to the parties should they need assistance in reaching agreements.

Saskatchewan Wheat Pool and Agricore Co-operative Ltd., the only two unionized workplaces, have negotiated new collective agreements that take into account the hours of work provisions of the Code. In order to mitigate the transition to the new regime, the two companies have agreed with their respective unions to apply the averaging provisions of the Code for the calculation of their hours of work and payment of overtime.

Contact

Fred Chilton, Manager, Labour Standards Policy and Legislation, Labour Program, Human Resources Development Canada, Place du Portage, Phase II, 165 Hôtel-de-Ville Street, Hull, Quebec K1A 0J2, (819) 953-0193 (Telephone), (819) 994-5264 (Facsimile), fred.chilton(hrdc-drhc.gc.ca (Electronic mail).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to paragraphs 175(1)(a) and (b) of the Canada Labour Code, proposes to make the annexed Regulations Repealing the Country Elevator Agents and Managers Hours of Work Regulations, 1979.

Interested persons may make representations with respect to the proposed repeal within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Fred Chilton, Manager, Labour Standards Policy and Legislation Division, Labour Program, Human Resources Development Canada, Ottawa, Ontario, K1A 0J2.

Ottawa, July 27, 2000.

MARC O'SULLIVAN
Assistant Clerk of the Privy Council

REGULATIONS REPEALING THE COUNTRY ELEVATOR AGENTS AND MANAGERS HOURS OF WORK REGULATIONS, 1979

REPEAL

1. The Country Elevator Agents and Managers Hours of Work Regulations, 1979 (see footnote 2) are repealed.

COMING INTO FORCE

2. These Regulations come into force on January 31, 2001.

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Regulations Repealing the Manufacturing and Storage of Patented Medicines Regulations

Statutory Authority

Patent Act

Sponsoring Department

Department of Industry

REGULATORY IMPACT ANALYSIS STATEMENT

Description

These Regulations repeal the Manufacturing and Storage of Patented Medicines Regulations.

The Manufacturing and Storage of Patented Medicines Regulations were enacted in 1993, as part of the reforms to the Patent Act brought into force with the passage of Bill C-91, An Act to Amend the Patent Act (1992). Foremost among these reforms was the phasing-out of the compulsory licencing regime, a federally regulated arrangement whereby second-entry drug manufacturers (usually generic drug companies) could, on the payment of royalties to patent-holding innovator drug manufacturers (usually brand-name drug companies), obtain licences to sell generic versions of patented drugs.

While Bill C-91 brought about the extinction of the regime of compulsory licencing, it also introduced into the Patent Act (the Act) two provisions that provide exceptions to the otherwise exclusive rights of the patentee to make, construct, use or sell a patented invention. The first such provision, subsection 55.2(1) of the Act, gives second-entry manufacturers the right to work a patented product for the purpose of completing whatever regulatory approval process applies to the product. The second such provision, subsection 55.2(2) of the Act, allows second-entry manufacturers to work a patented product for an "applicable period provided for by the Regulations" in order to stockpile an equivalent product which may then be sold after the relevant patents expire (assuming the regulatory approval process has been completed). In the pharmaceutical industry, these provisions are designed to promote the entry onto market of generic drugs as soon as possible after the expiry of the patents for the brand-name product.

Subsection 55.2(3) is the provision of the Patent Act that gives the Governor in Council the authority to make regulations for the purposes of the subsection 55.2(2) stockpiling exception. The Manufacturing and Storage of Patented Medicines Regulations were the only set of Regulations enacted pursuant to that authority. By providing for a six-month "applicable period", the Manufacturing and Storage of Patented Medicines Regulations gave effect to the stockpiling exception. The effect of the present Regulations repealing the Manufacturing and Storage of Patented Medicines Regulations is to render the stockpiling exception of no practical force or effect.

International Trade

Repealing the Manufacturing and Storage of Patented Medicines Regulations became necessary in order to comply with a ruling of the World Trade Organization (WTO) Dispute Settlement Body (DSB) dated April 7, 2000, adopting the Panel's report in the case of "Canada — Patent Protection for Pharmaceutical Products." That case arose out of a challenge to the exceptions of subsections 55.2(1) and (2) of Canada's Patent Act brought by the European Communities (EC) and their member States under the WTO Dispute Settlement Rules and Procedures. In the Panel's report, dated March 17, 2000, it endorsed the regulatory approval exception but found the stockpiling exception to be inconsistent with Canada's international obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

The TRIPS Agreement is annexed to the Agreement Establishing the World Trade Organization, which Canada entered into in 1994, following its participation in the Uruguay Round of Multilateral Trade Negotiations, the most recent round of multilateral trade talks under the General Agreement on Tariffs and Trade (GATT). TRIPS establishes intellectual property protection standards to which WTO members must subscribe. It came into force in Canada in 1996.

In challenging subsections 55.2(1) and (2) of the Patent Act, the EC argued that the two provisions gave rise to exceptions in patent protection which were incompatible with the exclusive rights mandated by TRIPS. In defence of subsections 55.2(1) and (2), Canada explained that the two provisions constituted limited exceptions permitted by TRIPS to the exclusive rights conferred by a patent and as such, were designed to foster a balanced patent regime which promotes effective patent protection, while allowing competitive drugs to reach the market as soon as possible upon patent expiry.

While there is ample evidence to indicate that the subsection 55.2(1) regulatory approval exception succeeds in its intended objective, evidence of a relationship between the subsection 55.2(2) stockpiling exception and the entry onto market of generic drugs is less clearly established. It has been demonstrated that without the regulatory approval exception, the market access of generic drugs would be delayed by a period of three to six and a half years (the average time required to complete the regulatory approval process for a generic drug). In contrast, even without the stockpiling exception, generic manufacturers typically have a number of months to manufacture and store product in the period between the regulatory approval date and the date a drug becomes listed on provincial formularies (upon which market penetration of generic drugs largely depends). Accordingly, Canada's loss on stockpiling is minimal when compared to its successful defence of the regulatory approval exception.

In finding the stockpiling exception to be inconsistent with TRIPS, the Panel concluded that "[t]he exception created by Section 55.2(2) does not become effective until implementing regulations are issued." It then noted that "[t]he only regulations issued to date under the stockpiling exception have been regulations making the exception operative with regard to pharmaceutical products." By repealing the Manufacturing and Storage of Patented Medicines Regulations, thereby rendering the stockpiling exception of no force and effect, Canada will have complied with the terms of the Panel's report and brought its patent protection into conformity with its TRIPS obligations.

Alternatives

In determining how to respond to the DSB's request that Canada bring subsection 55.2(2) into conformity with TRIPS, Industry Canada, Health Canada and the Department of Foreign Affairs and International Trade (DFAIT) considered two alternatives to repealing the Manufacturing and Storage of Patented Medicines Regulations.

Status Quo

Notwithstanding its international treaty obligations, Canada had the option not to implement the DSB's request. To do so, however, was considered unsound given that under WTO rules governing the settlement of trade disputes it would have allowed the EC to bring economic sanctions against Canada.

Legislative Change

Officials at Industry Canada, Health Canada and DFAIT also considered implementing the recommendations of the Panel by repealing subsection 55.2(2) of the Patent Act. However, in view of the fact that the implementation of the Panel's recommendation could be achieved either by regulatory or statutory repeal, the relative complexity and length of the legislative process militated towards implementation by regulation.

Benefits and Costs

Benefits

By repealing the Manufacturing and Storage of Patented Medicines Regulations these Regulations bring the protection provided by Canada's Patent Act into conformity with its international obligations under TRIPS. As a result, Canada will avoid the operation of Article 22 of the WTO Dispute Settlement Understanding (DSU), which calls for the payment of compensation or the suspension of concessions in the event that a member of the WTO fails to implement a Panel's recommendations.

Costs

The nature of the generic drug industry is such that effective market penetration for a generic product is chiefly dependant on its being listed as interchangeable with the brand name on provincial drug formularies. There is typically a lag time of several months between the date a generic drug manufacturer obtains Health Canada's regulatory approval for a drug and the date the drug becomes listed as an interchangeable product. Given that generic drug manufacturers have expressed confidence in their ability to generate industrial scale production levels in a very short space of time, the loss of the ability to stockpile patented drugs within the six months preceding patent expiry is not expected to have significant economic consequences on the generic drug industry. Nor is the loss of stockpiling expected to impact measurably upon Canadian consumers' access to generic drugs.

Consultations

The Government has maintained an ongoing dialogue with industry stakeholders throughout the proceedings before the WTO. In the context of doing so, an invitation was extended to stake-holders to participate in the formulation of Canada's defence submissions. This invitation was accepted by the Canadian Drug Manufacturers Association (CDMA), an interest group representing the generic drug industry. Consultations were also held with the Provinces to ensure that provincial officials were kept abreast of all material developments relating to the implementation of the Panel's recommendations.

Compliance and Enforcement

Patent rights are private rights which, when not respected, are enforceable through civil proceedings brought by the rights holder against the infringer. Accordingly, drug manufacturers who fail to comply with the repeal of the Manufacturing and Storage of Patented Medicines Regulations in a manner consistent with Canadian legal practice run the risk of infringement liability.

In determining the "reasonable period of time" for implementation Canada and the EC were unable to come to terms and the matter will therefore be decided through binding arbitration.

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subsections 55.2(2)(see footnote a) and (3)(see footnote b) of the Patent Act, proposes to make the annexed Regulations Repealing the Manufacturing and Storage of Patented Medicines Regulations.

Interested person may make representations with respect to the proposed Regulations within 30 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Serge Dupont, Director General, Corporate Governance Branch, Industry Canada, 5^th Floor, West Tower, 235 Queen Street, Ottawa, Ontario, K1A 0H5, (613) 952-0211 (Telephone), (613) 941-8151 (Facsimile).

Ottawa, July 27, 2000.

MARC O'SULLIVAN
Assistant Clerk of the Privy Council

REGULATIONS REPEALING THE MANUFACTURING AND STORAGE OF PATENTED MEDICINES REGULATIONS

REPEAL

1. The Manufacturing and Storage of Patented Medicines Regulations (see footnote 3) are repealed.

COMING INTO FORCE

2. The Regulations come into force on the day on which they are registered.

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Rules Amending the National Energy Board Rules of Practice and Procedure, 1995

Statutory Authority

National Energy Board Act

Sponsoring Agency

National Energy Board

REGULATORY IMPACT ANALYSIS STATEMENT

Description

Pursuant to paragraph 8(b) of the National Energy Board Act ("the Act"), the National Energy Board ("the Board") may make rules governing the making of applications, representations and complaints to the Board, as well as the conduct of its hearings. The Board has exercised that power by creating the National Energy Board Rules of Practice and Procedure, 1995 ("the Rules"). Subsection 8(8) of the Rules adopts in a general manner the rules of the Federal Court of Canada with respect to personal service of documents, in those situations where service of a document is required by the Act or the Rules. The adoption of the rules of the Federal Court in this respect are subject to certain minor changes concerning the manner in which Her Majesty the Queen is to be served.

Recent amendments to the rules of the Federal Court of Canada have been made and have caused a review of subsection 8(8) of the Board's Rules to be undertaken. As a result of that review, it has been determined that amendments to subsection 8(8) of the Rules are required to take into account changes made to the rules of the Federal Court and to clarify the manner in which Her Majesty in right of a province is to be served.

Alternatives

The alternative of not enacting the amendments was considered but was found to be an inadequate response to concerns expressed by the legal community respecting the potential for confusion in those provisions of the Board's Rules which apply to service of documents upon the Crown. Amending the Rules was considered to be the only viable alternative.

Benefits and Costs

The legal profession which engages in practice before the National Energy Board will benefit by this change because the amendment will provide legal certainty with respect to the manner of effecting service of documents on Her Majesty. The changes proposed by this amendment will not increase the costs borne by parties who are required to effect service of a document on Her Majesty.

Compliance and Enforcement

Service of documents is an integral part of regulatory proceedings administered by the Board. Proper service is enforced by the Board as part of its normal duties in an adjudicative process. Improper service of documents can result in the denial of relief requested by a party from the Board. No additional compliance or enforcement mechanisms will be necessary as a result of these amendments.

Contact

Peter W. Noonan, Counsel, National Energy Board, 444 Seventh Avenue SW, Calgary, Alberta T2P 0X8, (403) 299-3552 (Telephone), (403) 299-2710 (Facsimile).

PROPOSED REGULATORY TEXT

Notice is hereby given that the National Energy Board, pursuant to paragraph 8(b) of the National Energy Board Act, proposes to make the annexed Rules Amending the National Energy Board Rules of Practice and Procedure, 1995.

Interested persons may make representations with respect to the proposed Rules within 30 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Mr. Michel Mantha, Secretary, 444 Seventh Avenue SW, Calgary, Alberta, T2P 0X8, e-mail: mmantha@neb.gc.ca.

NATIONAL ENERGY BOARD
MICHEL L. MANTHA
Secretary

RULES AMENDING THE NATIONAL ENERGY BOARD RULES OF PRACTICE AND PROCEDURE, 1995

AMENDMENT

1. Subsection 8(8)(see footnote 4) of the National Energy Board Rules of Practice and Procedure, 1995(see footnote 5) is replaced with the following:

(8) The service that is required under paragraph 34(1)(a) and subsection 104(2) of the Act and under subsection 40(4) of these Rules shall be personal service and shall be effected in accordance with Part 3 of the Federal Court Rules, 1998, except that

(a) personal service on Her Majesty in right of Canada shall be effected in the manner prescribed in the Crown Liability and Proceedings (Provincial Court) Regulations; and

(b) personal service on Her Majesty in right of a province shall be effected by leaving a copy of the document with a lawyer employed at the principal office of either the provincial Department of Justice or the Attorney General, as the case may be.

(8.1) For greater certainty, a reference in the Federal Court Rules, 1998 to the word "Court" is deemed to be a reference to the Board.

COMING INTO FORCE

2. These Rules come into force on the day on which they are registered.

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Footnote 1

C.R.C., c. 870

Footnote 2

SOR/79-248

Footnote a

S.C. 1993, c. 2, s. 4

Footnote b

S.C. 1993, c. 2, s. 4

Footnote 3

SOR/93-134

Footnote 4

SOR/98-573

Footnote 5

SOR/95-208

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