Drug legislation and regulation as

part of the health care system

Valerio Reggi, Eshetu Wondemagegnehu

HTP/EDM/QSM - 3 October 2001
1 PAR Seminar, 3 October 2002 WHO - EDM
 Rationale for govt role

Essential govt functions in the pharmaceutical

sector
 Policy making, priority setting: what are
the problems? how do we address them? how do
we know what we have achieved?
 Regulation & control: what are the rules?
are the rules respected? do we need to change
rules?
 Professional standards: who is allowed to
do what?
 Access to drugs: can people use the drugs
they need?
 Information: can people use drugs properly?
2 PAR Seminar, 3 October 2002 WHO - EDM
 Rationale for govt role

Consequences of weak drug regulatory capacity

Irrational consumption and prescription,

substandard, counterfeit, harmful,
useless drugs on sale

3 PAR Seminar, 3 October 2002 WHO - EDM

 Key elements of drug legislation

Scope of drug legislation

 What products should be regulated?

 What companies/institutions should be
regulated?
 What activities should be regulated?
 To what extent should the above be regulated?
 Who should be responsible for regulation?
 What sanctions should apply in case of
violations?
4 PAR Seminar, 3 October 2002 WHO - EDM
 Key elements of drug regulatory system

Drug regulation comprises all the legal, administrative

& technical arrangements meant to ensure that:

 all premises, persons & practices engaged in the

development, manufacture, importation,
exportation, wholesale, supply, dispensing &
promotion of drugs comply with approved
standards, norms, procedures and requirements
 drug products are safe, effective and of acceptable
quality
 product information is unbiased, accurate and
appropriate
 drugs are available
 drugs are used rationally
5 PAR Seminar, 3 October 2002 WHO - EDM
 Key elements of drug regulatory system

Basic functions in drug regulation (1)

 Licensing of manufacturers, importers,

distributors, wholesale and retail outlets
(premises, persons and practices)
 Marketing authorization for drug products
 Quality control laboratory testing
 Provision of drug information and monitoring of
drug promotion and advertising
Continues……...

6 PAR Seminar, 3 October 2002 WHO - EDM

 Key elements of drug regulatory system

….continued
Basic functions in drug regulation (2)

 Inspection of manufacturing and distribution

channel premises
 Adverse drug reaction monitoring
 Authorization of clinical trials
 Monitoring of drug dispensing and prescribing
practices
 Monitoring of drug utilization and promotion of
rational drug use
 Application of sanctions
7 PAR Seminar, 3 October 2002 WHO - EDM
 Drug regulation is a multi- faceted activity at
the centre of complex interactions

Government Experts
Manufacturers

Regulatory Prescribers
Products
authority
Medicines

Patients/Consumers
Importers/Wholesalers/Retailers

8 PAR Seminar, 3 October 2002 WHO - EDM

 Drug regulation is a multi- faceted activity at
the centre of complex interactions

Government Experts
Manufacturers

Regulatory Prescribers
Products
authority
Medicines

Patients/Consumers
Importers/Wholesalers/Retailers

9 PAR Seminar, 3 October 2002 WHO - EDM

 Drug regulation is a multi- faceted activity at
the centre of complex interactions

Government Experts
Manufacturers

Regulatory Prescribers
Products
authority
Medicines

Patients/Consumers
Importers/Wholesalers/Retailers

10 PAR Seminar, 3 October 2002 WHO - EDM

 Drug regulation is a multi- faceted activity at
the centre of complex interactions

Government Experts
Manufacturers

Regulatory Prescribers
Products
authority
Medicines

Patients/Consumers
Importers/Wholesalers/Retailers

11 PAR Seminar, 3 October 2002 WHO - EDM

 Drug regulation is a multi- faceted activity at
the centre of complex interactions

Government Experts
Manufacturers

Regulatory Prescribers
Products
authority
Medicines

Patients/Consumers
Importers/Wholesalers/Retailers

12 PAR Seminar, 3 October 2002 WHO - EDM

 The challenges:

 the health system counts on DRA for good, safe,

and effective medicines and for fair rules and
control on drug trade, information, and use
 any strategy to improve anything in the
pharmaceutcal area involves DRA
 any problem encountered in the pharmaceutical
area has something to do with the DRA

13 PAR Seminar, 3 October 2002 WHO - EDM

 Strategies for achieving effective drug
regulation

1. Assess drug regulation performance

2. Identify and develop priority functions
3. Provide clear mission and purpose
4. Create a supportive environment
5. Formulate adequate legislation
6. Create appropriate organisational structure
7. Allocate adequate human and financial resources
8. Minimise corruption and conflict of interest
9. Apply appropriate regulatory & enforcement
strategies

14 PAR Seminar, 3 October 2002 WHO - EDM

 Access to quality drugs:

To ensure access to quality drugs

there is no better strategy than
building a reliable and effective
national drug regulatory authority

15 PAR Seminar, 3 October 2002 WHO - EDM

  ..\..\GMP - Movie\MVI_DEMO (F)\movies\0019.mpg

16 PAR Seminar, 3 October 2002 WHO - EDM