Assessment of the Pharmaceutical Situation in Kenya - A Baseline Survey: APPENDICES: APPENDIX 6

APPENDIX 6 - COMPLETED LEVEL ONE QUESTIONNAIRE

Questionnaire on structures and processes of country pharmaceutical situation

Country 96 Kenya (AFRO)
Date (dd/mm/yyyy)
30^th April 2003

Name of respondent(s)

Dr. Kipkerich Koskei

Position(s) Chief Pharmacist, Ministry of Health

Dr. Bibiana Njue

Deputy Chief Pharmacis

2003

Latest WHO Data

1. NATIONAL MEDICINES (DRUG) POLICY (NMP)

1.1 Is there a National Medicines Policy (NMP) document? (See glossary for a definition of NMP.) If no, skip to 1.4.

Yes/No/Don’t Know Yes

Yes

Is it an official or draft document?

Official/Draft/Don’t Know Official

Official

What year was it last updated?

Year 1994

1994

1.2 Is there an NMP implementation plan that sets activities, responsibilities, budgets, and timeline?

Yes/No/Don’t Know Yes

If yes, when was it last updated?

Year 1996

1.3 Is the NMP integrated into a published/official national health policy/plan? If yes, when was it last updated?

Yes/No/Don’t Know Yes Year 1999

1.4 Is there a national policy on traditional and complementary/ alternative medicine (TM/CAM) either as part of the medicines policy or health policy or as a separate document? (TM/CAM is defined in the glossary.)

Yes/No/Don’t Know No

If yes, when was it last updated?

Year ____

1.5 Has a national assessment/indicator study been conducted? If yes, what areas have been studied and when was the most recent study covering each area conducted?

Yes/No/Don’t Know No

Overall pharmaceutical situation:

Yes/No/Don’t Know No Year ____

Rational use/prescription audit:

Yes/No/Don’t Know No Year ____

Access:

Yes/No/Don’t Know No Year ____

2. LEGISLATION/REGULATION

2.1 Is there a medicines law? If yes, when was it last updated? Which of the following areas are covered by medicines legislation and when was each last updated?

Yes/No/Don’t Know Yes Year 2001

Establishment of regulatory authority:

Yes/No/Don’t Know Yes Year 2001

Yes

Marketing authorisation of pharmaceuticals:

Yes/No/Don’t Know Yes Year 1982

Yes 1983

Manufacturing of medicines:

Yes/No/Don’t Know Yes Year 1992

Yes 1983

Distribution of medicines:

Yes/No/Don’t Know Yes Year 1957

Yes 1983

Promotion & advertising of medicines:

Yes/No/Don’t Know Yes Year 2002

Yes 1983

Importation of medicines:

Yes/No/Don’t Know Yes Year 1957

Yes 1983

Exportation of medicines:

Yes/No/Don’t Know Yes Year 1957

Licensing & practice of prescribers:

Yes/No/Don’t Know Yes Year ____

Yes 1983

Licensing & practice of pharmacy:

Yes/No/Don’t Know Yes Year 2001

Yes 1983

Herbal medicines (See glossary for definition):

Yes/No/Don’t Know No Year ____

Empowers inspectors to enter premises and collect samples and documentation:

Yes/No/Don’t Know Yes Year 1957

Requires transparency, accountability and code of conduct in regulatory work:

Yes/No/Don’t Know No Year ____

2.2 System and operation of medicines registration:

a) Is marketing authorisation required for medicines to be sold? If yes, how many medicinal products have been approved to be marketed? (express as number of dosage forms & strengths)

Yes/No/Don’t Know Yes
Total 8232

5000

Is marketing authorisation required for herbal medicines to be sold? If yes, how many herbal medicinal products have been approved to be marketed? (express as number of dosage forms & strengths) (See glossary for a definition of herbal medicines)

Yes/No/Don’t Know No
Total

b) Are there detailed written guidelines, including reference guidelines and criteria, for submitting applications for the registration of medicinal products? Are there guidelines covering the registration of herbal medicines?

Yes/No/Don’t Know Yes
Yes/No/Don’t Know No

c) Is the WHO Certification Scheme certificate required as part of the marketing authorisation process?

Yes/No/Don’t Know Yes

d) Is INN used in the registration of medicines?

Yes/No/Don’t Know Yes

e) Is a list of all registered products publicly accessible? (Registered product is defined in the glossary.)

Yes/No/Don’t Know Yes

Yes

2.3 Is there a computerised registration system that facilitates retrieval of information on registered products? (Registration system is defined in the glossary.)

Yes/No/Don’t Know Yes

Is there a medicines regulatory authority website providing publicly accessible information on any of the following: legislation, regulatory procedures, prescribing information (such as indications, counterindications, side effects, etc.), authorised companies, and/or approved medicines?

Yes/No/Don’t Know No

2.4 Is licensing a requirement? (Licensing is defined in the glossary.) If yes, is it based on site inspection of:

Yes/No/Don’t Know Yes

Manufacturers:

Yes/No/Don’t Know Yes

Yes

Importers/wholesalers:

Yes/No/Don’t Know Yes

Retail distributors/pharmacies:

Yes/No/Don’t Know Yes

Yes

2.5 Are there written national guidelines/codes/checklists for the inspection of:

Manufacturers:

Yes/No/Don’t Know No

Importers/wholesalers:

Yes/No/Don’t Know No

Retail distributors/pharmacies:

Yes/No/Don’t Know No

2.6 Is prescribing by generic name obligatory in the:

Public sector:

Yes/No/Don’t Know Yes

Yes

Private sector:

Yes/No/Don’t Know No

Is generic substitution permitted at: (Generic substitution is defined in the glossary.)

Public pharmacies:

Yes/No/Don’t Know Yes

Yes

Private pharmacies:

Yes/No/Don’t Know Yes

Yes

2.7 Is promotion/advertisement of medicines regulated by:

Company self-regulation:

Yes/No/Don’t Know No

Government agency

Government agency or medicines regulatory authority:

Yes/No/Don’t Know Yes

Are civil society/non-governmental organisations involved in review, assessment, or surveillance of promotion/ advertisement of medicines?

Yes/No/Don’t Know No

Do regulations on promotion/advertisement of medicines include: (See glossary for the distinction between promotion and advertisement.)

Published ethical criteria for medicines promotion:

Yes/No/Don’t Know Yes

Pre-approval for promotional materials:

Yes/No/Don’t Know Yes

Pre-approval for advertisement materials:

Yes/No/Don’t Know Yes

Explicit prohibition on advertising prescription medicines:

Yes/No/Don’t Know Yes

Yes

Detailed restrictions on advertising non-prescription medicines:

Yes/No/Don’t Know No

2.8 Are adverse drug reactions (ADR) monitored? If yes, what is the total number of each of the following for the most recent year for which data is available?

Yes/No/Don’t Know No

Total number of validated ADR reports received:

____ (Year ____) DK

Total number of reporting physicians:

____ (Year ____) DK

Total number of physicians in country:

____ (Year ____) DK

Are ADR of herbal medicines monitored?

Yes/No/Don’t Know No

3. QUALITY CONTROL OF PHARMACEUTICALS

3.1 Testing of medicines samples collected last year for regulatory purposes (i.e. including drug registration and post-marketing surveillance, but excluding testing done in conjunction with procurement activities):

Total number of samples

Total number of samples collected:

___ 350

Don’t Know

Total number of samples tested:

___ 61

Don’t Know

Total number of samples that failed identity or assay:

___ 12

Don’t Know

3.2 Where have the above samples (see 3.1) been tested:

Percentage of total samples tested

Government quality control laboratory:

100%

Don’t Know

Local academic institutions:

Don’t Know

Quality control laboratory in another country:

Don’t Know

Private quality control laboratory:

Don’t Know

4. ESSENTIAL MEDICINES LIST (EML)

4.1 Are there Essential Medicines Lists (EML)? (An Essential Medicines List is a government-approved selective list of medicines or national reimbursement list)

Total number of medicines

Year of last update

Total no. Meds

Year up-dated

National EML:

Yes/No/DK Yes

254

2002

Yes

330

1993

State or provincial list:

Yes/No/DK Yes

254

2002

List for primary health care:

Yes/No/DK Yes

2002

4.2 Are EMLs being used in: Public sector procurement:

Yes/No/Don’t Know Yes

Public insurance reimbursement:

Yes/No/Don’t Know No

Private insurance reimbursement:

Yes/No/Don’t Know No

4.3 Are local herbal medicines included on the national EML?

Yes/No/Don’t Know No

5. MEDICINES SUPPLY SYSTEM

5.1 Who is responsible for

Procurement

Distribution

public sector drug procurement and distribution? What percentage of the total cost is each responsible for?

Yes/No/DKYes 30%

Yes/No/DKYes 80%

Ministry/Department of Health:

Non-governmental organisation (NGO):

Yes/No/DKNo 0%

Private institution contracted by the government:

Yes/No/DKYes 70%

Yes/No/DKNo 0%

Individual health institutions:

Yes/No/DKYes 0%

Yes/No/DKYes 20%

5.2 Is government procurement limited to medicines on the EML?

Yes/No/Don’t Know Yes

Yes

If no, is a percentage of the budget set aside for non-EML items?

Yes/No/Don’t Know

What is the percentage?

5.3 Type of tender and percentage of the total cost for each:

Percentage of total cost

(Tender is the process by which competing bids are entered for a particular contract.) National competitive tender:

Yes/No/DKYes

International competitive tender:

Yes/No/DKYes

95%

91%

Negotiation/direct purchasing:

Yes/No/DKNo

5.4 Is drug registration a prerequisite for government purchases?

Yes/No/Don’t Know Yes

6. MEDICINES FINANCING

6.1 What is the total public or government budget for medicines in US$ for the most recent year for which data is available?

$ _____ 16,000,000, Year 2002/3

6.2 Are there guidelines on medicines donations that cover the public sector, the private sector, or non- governmental organisations (NGO)?

Public Sector

Private Sector

NGO

Yes/No/DK Yes

Yes/No/DK No

Yes/No/DK Yes

6.3 Which medicines are

free at primary public health facilities:

Yes/No/Don’t Know No

All medicines are free of charge:

Malaria medicines are free:

Yes/No/Don’t Know Yes

Tuberculosis medicines are free:

Yes/No/Don’t Know Yes

Sexually transmitted diseases medicines are free:

Yes/No/Don’t Know Yes

HIV/AIDS-related medicines are free:

Yes/No/Don’t Know No

Medicines are free to those who cannot afford them:

Yes/No/Don’t Know Yes

Medicines are free for children under 5 years of age:

Yes/No/Don’t Know Yes

Medicines are free for pregnant women:

Yes/No/Don’t Know Yes

Medicines are free for elderly persons:

Yes/No/Don’t Know No

No medicines are free of charge:

(Don’t Know )

6.4 Which fees are charged in public health facilities:

Registration/Consultation fees:

Yes/No/Don’t Know Yes

Dispensing fees:

Yes/No/Don’t Know No

Flat fees for medicines:

Yes/No/Don’t Know Yes

Flat rate copayments:

Yes/No/Don’t Know No

Percentage copayments:

Yes/No/Don’t Know No

(Co-payments cover part of the cost of medicines, the other part being paid by an insurer or government.)

6.5 Is revenue from fees or drug sales used to pay the salaries of public health personnel in the same facility?

Always/Frequently/Occasionally/Never/DK Never

6.6 Health insurance: (Health insurance is any prepayment scheme for health care costs additional to but excluding subsidies funded through the Ministry of Health budget.)

Public

Private

Public

Private

What percentage of the population has health insurance?

All/Some/None/DK
None

All/Some/None/DK
Don't know

Are medicines covered by health insurance?

All/Some/None/DK
None

All/Some/None/DK
Some

Yes

Of the covered medicines, what percentage of the cost is covered:

___ %

100 %

6.7 Is there a pricing policy on medicines that covers the public sector, the private sector, or non-governmental organisations?

Public sector

Private sector

NGO

Yes/No/DK

If yes, does it apply to:

All medicines, some or none:

All/Some/None DK

Is maximum wholesale mark up established in laws/regulations:

Yes/No/DK

If yes, amount:

___ %

Maximum retail mark up established in laws/regulations:

Yes/No/DK

If yes, amount:

___ %

Duty on imported raw pharmaceutical materials:

Yes/No/DK

Duty on imported finished pharmaceutical products:

Yes/No/DK

7. ACCESS TO ESSENTIAL MEDICINES

7.1 In your opinion, what percentage of the population has regular access to essential medicines (i.e. minimum of 20 most essential medicines available and affordable at public and private facilities within a one-hour walking distance)?

30 %

35%

7.2 What percentage of:

Public health facility

Private health facility

Public or private retail drug outlet

The population is within one-hour walking distance to:

50%

70 %

80%

Facilities have essential medicines available:

60%

80%

95%

The population can afford essential medicines at:

60%

30%

50%

8. PRODUCTION

8.1 What is the medicines production capability in the country?

Yes/No/Don’t Know No

Research and development of new active substances:

Production of pharmaceutical active starting materials:

Yes/No/Don’t Know No

Formulation from pharmaceutical starting materials:

Yes/No/Don’t Know Yes

Repackaging of finished dosage forms:

Yes/No/Don’t Know Yes

8.2 For each of the following types of local production, indicate number of factories and total annual sales in US$ for the most recent year for which data is available:

Number of factories

Sales in US$

Year

Don’t know

Starting materials:

None

____

Finished products:

$53,000,000

2002

Products containing active substances developed/marketed for the first time during the last 5 years:

8.3 What is the total volume and US$ value of the medicines market? Generic medicines compose what percentage of market volume and value?

Volume ____, Value $ ____
Volume ____ %, Value ____ %

9. RATIONAL USE OF MEDICINES

9.1 Are there standard treatment guidelines (STGs) produced by the health ministry/department for major conditions? (STGs are recommendations about how to treat a clinical condition.)

Number of conditions/ diseases

Year of publication or review

National STG:

Yes/No/DK Yes

___

2002

1994

STG for hospital level:

Yes/No/DK No

___

STG for primary health care level:

Yes/No/DK Yes

___

9.2 Is there a National Medicines Formulary manual? (A formulary manual contains summary drug information.)

Yes/No/Don’t Know No

If yes, does it cover only medicines on the Essential Medicines List?

Yes/No/Don’t Know

What year was it last published/reviewed:

Year ____

9.3 Are any of the following aspects of the essential medicines concept generally part of the basic curricula in most health training institutions/universities for:

Essential Medicines List

Standard Treatment Guidelines

Problem- based pharmaco therapy

Rational prescribing

(Essential medicines are those that satisfy the priority health care needs of the population. See glossary for a definition of problem-based pharmacotherapy.)

Yes/No/DK

Doctors:

Yes

Yes/No/DK
Yes

Yes

Nurses:

Yes/No/DK
Yes

Yes

Pharmacists:

Yes/No/DK
Yes

Yes

Pharmacy assistants:

Yes/No/DK
Yes

Yes

Paramedical staff:

Yes/No/DK
No

Yes/No/DK
Yes

9.4 Are there independent publicly or non- commercially funded obligatory continuing education programs which include use of medicines for:

Doctors:

Yes/No/Don’t Know No

Yes

Nurses/midwives/paramedical staff:

Yes/No/Don’t Know No

Yes

Pharmacists:

Yes/No/Don’t Know No

Yes

Pharmacy aides/assistants:

Yes/No/Don’t Know No

Yes

9.5 Is there a public or independently funded nationally accessible (e.g. by phone) medicines information centre or service co-ordinated by the Ministry of Health, academia, and/or a non-commercial non-governmental organisation that provides information on demand to:

Prescribers:

Yes/No/Don’t Know No

Dispensers:

Yes/No/Don’t Know No

Consumers:

Yes/No/Don’t Know No

9.6 Has there been any public education campaign concerning rational medicines use in the previous two years conducted by Ministry of Health/non-governmental organisation/academia on the following topics:

Use of antibiotics:

Yes/No/Don’t Know No

Use of injections:

Yes/No/Don’t Know No

Other topics/issues:

Yes/No/Don’t Know Don't know

9.7 How often do the following personnel prescribe at the primary health care level in the public sector?

Doctors:

Always/Frequently/Occasionally/Never/DK Occasionally

Nurses/midwives/paramedical staff:

Always/Frequently/Occasionally/Never/DK Frequently

Pharmacists:

Always/Frequently/Occasionally/Never/DK Never

Pharmacy aides/assistants:

Always/Frequently/Occasionally/Never/DK Never

Personnel with less than one month formal health training:

Always/Frequently/Occasionally/Never/DK Never

9.8 Is there a government department with a specific mandate to promote the rational use of medicines and co-ordinate medicines use policies?

Yes/No/Don’t Know Yes

9.9 What proportion of facilities have a drugs and therapeutics committee? (A drugs and therapeutics committee promotes the safe and effective use of medicines in the facility or area under its jurisdiction)

Referral hospitals:

All/Most/Half/Few/None/Don’t Know All

General hospitals:

All/Most/Half/Few/None/Don’t Know Few

Regions/provinces:

All/Most/Half/Few/None/Don’t Know Few

Is there a mandate for drugs and therapeutics committees in the national medicines policy?

Yes/No/Don’t Know Yes

9.10 Is there a national strategy to contain antimicrobial resistance?

Yes/No/Don’t Know Yes

Is there a national reference laboratory to coordinate epidemiological surveillance of antimicrobial resistance?

Yes/No/Don’t Know Yes

Is there a funded national intersectoral task force to coordinate the implementation of interventions to promote appropriate use of antimicrobials and prevent the spread of infection?

Yes/No/Don’t Know No

9.11 Are the following medicines sold over the counter without any prescription?

Antibiotics:

Always/Frequently/Occasionally/Never/DK Never

Injections:

Always/Frequently/Occasionally/Never/DK Never

10. INTELLECTUAL PROPERTY RIGHTS PROTECTION AND MARKETING AUTHORIZATION (See glossary for definitions of terms used in this section.)

10.1 Is patent protection legally provided for pharmaceutical products? If yes, indicate:

Yes/No/Don’t Know Yes

Year introduced:

____

Type:

Process/Product/Both/Don’t Know Both

Duration of patent validity:

17 Years

10.2 Which intellectual property right protection regime/activities are provided for traditional medical knowledge?

Year introduced

Duration of data protection

TRIPS:

Yes/No/DKNo

____

Sui generis regimes:

Yes/No/DKNo

____

Digital library:

Yes/No/DKNo

____

National inventory of medicinal plants:

Yes/No/DKNo

____

Others:

Yes/No/DKNo

____

None:

(DK )

10.3 TRIPS Agreement (Agreement on Trade Related Aspects of Intellectual Property Rights):

a) Is your country a World Trade Organization Member?
If no, skip to 10.4

Yes/No/Don’t Know Yes

b) Has national legislation been modified to implement the TRIPS Agreement? If yes, what year did it go into effect?

Yes/No/Don’t Know Yes Year 2001

c) Is your country availing itself of the transitional period provided by Article 65 of the TRIPS Agreement?

Yes/No/Don’t Know No

d) If your country is a least-developing country (LDC), has it availed itself of the transitional period accorded to LDCs in Article 66 of the TRIPS Agreement?

Yes/No/DK/Country not an LDC
Country not an LDC

10.4 Have parallel importing provisions on pharmaceuticals been incorporated into national legislation? If yes, have these provisions been applied?

Yes/No/DK/Currently being discussed Yes
Yes/No/DK/Currently being discussed No

10.5 Have compulsory licensing provisions for pharmaceuticals been incorporated into national legislation? If yes, under what conditions?

Yes/No/DK/Currently being discussed Yes

National emergency:

Yes/No/Don’t Know Yes

Public non-commercial use:

Yes/No/Don’t Know Yes

Remedying anti-competitive practices:

Yes/No/Don’t Know No

Other:

Yes/No/Don’t Know No

10.6 Are generic pharmaceutical manufacturers allowed to use patented inventions for the purpose of obtaining marketing approval prior to patent expiration?

Yes/No/DK/Currently being discussed No

COMMENTS ABOUT INDICATORS AND VALUES

Item Number	Comment

Questionnaire on structures and processes of country pharmaceutical situation

Glossary of Terms:

Advertisement: A set of activities undertaken to advertise medicines. It is usually targeted to the general public and it is usually limited to over-the-counter medicines.

Compulsory licensing: This term is used when the judicial or administrative authority is allowed by law to grant a license, without permission from the holder, on various grounds of general interest (absence of working, public health, economic development, and national defence). “Working” of a patent is the execution of the invention in the country of registration.

Co-payments: Co-payments cover part of the cost of medicines, the other part being paid by an insurer or government.

Drugs and therapeutics committee: A drugs and therapeutics committee promotes the safe and effective use of medicines in the facility or area under its jurisdiction.

Essential Medicines List: An Essential Medicines List is a government-approved selective list of medicines or national reimbursement list.

Essential medicines: Essential medicines are those that satisfy the priority health care needs of the population.

Generic substitution: The practice of substituting a product, whether marketed under a trade name or generic name, by an equivalent product, usually a cheaper one, containing the same active ingredient(s).

Health insurance: Health insurance is any prepayment scheme for health care costs additional to but excluding subsidies funded through the Ministry of Health budget. The purpose of question 6.6 is to identify how much protection the population has against exposure to the cost of medicines at the time people are sick. Prepaid financing is the usual method for providing such protection. Public funding through the (prepaid) Ministry of Health budget is the most widespread form of prepayment. Question 6.5 attempts to identify additional prepayment protection (percentage of the population covered and degree of protection against medicine costs) such as private or employer-based health insurance, community prepayments schemes, social health insurance (health care funded through social security systems), etc.

Herbal Medicines: Herbal medicines are plant-derived material or preparations with therapeutic or other human health benefits, which contain either raw or processed ingredients from one or more plants. Herbal medicines include herbs, herbal materials, herbal preparations and finished herbal products, which are classified in the medicines category according to a national regulatory framework. Finished herbal products and mixture herbal products may contain excipients in addition to the active ingredients, however, finished products or mixture products to which chemically defined active substances have been added, including synthetic compounds and/or isolated constituents from herbal materials, are not considered to be herbal. In some countries, herbal medicines may also contain, by tradition, natural organic or inorganic active ingredients which are not of plant origin.

Licensing: Licensing is a system that subjects all premises to evaluation against a set of requirements before a specific activity (e.g. manufacturing, storage etc.) is authorised to take place.

Medicines formulary manual: A formulary manual contains summary drug information.

National medicines (drug) policy (NMP): A national medicines policies is an expression of the government’s goals and priorities for the medium to long term for the pharmaceutical sector. It also identifies the main strategies for attaining them. It provides a framework within which the activities of the pharmaceutical sector can be coordinated. It covers both the public and private sectors, and involves all the main actors in the pharmaceutical field.

Parallel importing: Parallel importation is importation, without the consent of the patent-holder, of a patented product marketed in another country either by the patent-holder or with the patent-holder’s consent. Parallel importation enables promotion of competition for the patented product by allowing importation of equivalent patented products marketed at lower prices in other countries.

Problem-based pharmacotherapy: Problem-based pharmacotherapy is a problem-based practical approach to teaching prescribing.

Promotion: A set of activities undertaken to promote prescription of prescription-only medicines. It is usually targeted to health providers only and it is usually forbidden to target the general public. Registered products: Products that have been evaluated for quality, safety and efficacy and thence authorised for marketing.

Registration system: A system that subjects all products to evaluation of quality, safety and efficacy before they are authorised for marketing.

Standard Treatment Guidelines (STG): STGs are recommendations about how to treat a clinical condition.

Tender: Tender is the process by which competing bids are entered for a particular contract. Traditional medical knowledge: Knowledge related to traditional medicine (see definition of Traditional medicine and complementary/alternative medicine).

Traditional medicine and complementary/alternative medicine (TM/CAM): Traditional medicine is the sum total of the knowledge, skills, and practices based on theories, beliefs and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health as well as in prevention, diagnosis, improvement or treatment of physical and mental illnesses. The terms “complementary medicine” and “alternative medicine” can be used interchangeably with “traditional medicine” in some countries. The term “complementary and alternative medicine” can also be used to refer to a broad set of health care practices that are not part of the country’s own tradition and are not integrated into the dominant health care system.

Transitional period: TRIPS provides transitional periods during which countries are required to bring their national legislation and practices into conformity with its provisions. The latest dates for WTO Members were/are: 1996 for developed countries; 2000 for developing countries (as a general rule); 2005 for developing countries who had not introduced patents before joining the WTO; and 2006 for least-developed countries (extended to 2016 by the Doha Declaration). The TRIPS Agreement specifically recognizes the economic, financial, administrative and technological constraints of the least-developed countries. It therefore provides the possibility for further extension of the transitional period.

TRIPS Agreement (Agreement on Trade Related Aspects of Intellectual Property Rights)

Article 65: Transitional Arrangements

1. Subject to the provisions of paragraphs 2, 3 and 4, no Member shall be obliged to apply the provisions of this Agreement before the expiry of a general period of one year following the date * of entry into force of the WTO Agreement.

* [WIPO note] January 1, 1995

2. A developing country Member is entitled to delay for a further period of four years the date of application, as defined in paragraph 1, of the provisions of this Agreement other than Articles 3, 4 and 5.

3. Any other Member which is in the process of transformation from a centrally-planned into a market, free-enterprise economy and which is undertaking structural reform of its intellectual property system and facing special problems in the preparation and implementation of intellectual property laws and regulations, may also benefit from a period of delay as foreseen in paragraph 2.

4. To the extent that a developing country Member is obliged by this Agreement to extend product patent protection to areas of technology not so protectable in its territory on the general date of application of this Agreement for that Member, as defined in paragraph 2, it may delay the application of the provisions on product patents of Section 5 of Part II to such areas of technology for an additional period of five years.

5. A Member availing itself of a transitional period under paragraphs 1, 2, 3 or 4 shall ensure that any changes in its laws, regulations and practice made during that period do not result in a lesser degree of consistency with the provisions of this Agreement.

Article 66: Least-Developed Country Members

1. In view of the special needs an requirements of least-developed country Members, their economic, financial and administrative constraints, and their need for flexibility to create a viable technological base, such Members shall not be required to apply the provisions of this Agreement, other that Articles 3, 4 and 5, for a period of 10 years from the date of application as defined under paragraph 1 of Article 65. The Council for TRIPS shall, upon duly motivated request by a least-developed country Member, accord extensions of this period.

2. Developed country Members shall provide incentives to enterprises and institutions in their territories for the purpose of promoting and encouraging technology transfer to least-developed country Members in order to enable them to create a sound and viable technological base.