PAKISTAN

PHARMACEUTICAL COUNTRY PROFILE

ii

Pakistan. Pharmaceutical Country Profile

Foreword
This 2010 Pharmaceutical Country Profile for Pakistan has been produced by the Ministry of Health with support of the World Health Organization. This document contains information on structures, process and outcomes of the pharmaceutical sector in Pakistan. Some of the data comes from global sources (e.g. the World Health Statistics) or from surveys conducted in the previous years, while other pieces of information have been collected at country level in 2010. The sources of data for each piece of information are presented in the tables that can be found at the end of this document. On the behalf of the Ministry of Pakistan, I wish to express my appreciation towards Dr Khalid Saeed Bukhari from WHO for his contribution to the data collection and to the development of this profile. It is my hope that partners, researchers and all those that are interested in the pharmaceutical sector of Pakistan will find this profile a useful tool in their activities. Name: Prof Dr Rashid Jooma Function in the Ministry of Health: Director General, Ministry of Health, Date: 11 November 2010

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Table of content
Foreword ...................................................................................iii Table of content .......................................................................... iv Introduction ................................................................................1 Section 1 - Health and Demographic Data .............................................3 Section 2 - Health Services ...............................................................4 Section 3 - Policy Issues...................................................................8 Section 4 - Regulation................................................................... 11 Section 5 - Medicines Financing ....................................................... 15 Section 6 - Pharmaceutical procurement and distribution in the public sector 18 Section 7 - Selection and rational use of medicines................................ 19 Section 8 - Household data/access.................................................... 21 References ................................................................................ 22 ANNEX ..................................................................................... 25

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Introduction
This Pharmaceutical Country Profile provides data on structures, processes and outcomes of the pharmaceutical sector of Pakistan. The aim is to put together existing information and to make all relevant information on the pharmaceuticals sector available to the public in a user-friendly format. In 2010, country profiles similar to this one have been developed for 13 pilot countries. During 2011, the World Health Organization plans to support all WHO Member States to develop similar country profiles. The information is categorized in 8 sections, namely: (1) Health and Demographic data, (2) Health Services, (3) Policy Issues, (4) Regulation, (5) Medicines Financing, (6) Supply of Pharmaceuticals, (7) Rational Use of Medicines, and (8) Household Surveys. The indicators have been divided into two categories, namely "core" (most important) and "supplementary" (useful if available). The narrative profile is based only on the core indicators; while the tables in the annexes present all indicators. For each piece of information, we have tried to indicate the year and source of the data; these are used to build the references in the profile and are also indicated in the tables. If key national documents are available on-line, links are provided to the source documents so that the user can easily access these documents The selection of indicators for the profiles has involved all technical units working in the Essential Medicines Department of the World Health Organization as well as experts from WHO Regional and Country Offices, Harvard Medical School, Oswaldo Cruz Foundation (known as Fiocruz), University of Utrecht, the Austrian Federal Institute for Health Care and representatives from 13 pilot countries. Data collection in the pilot countries was conducted using a user-friendly electronic questionnaire that included a comprehensive glossary. Countries were requested not to conduct any

additional surveys, but only to enter the results from previous surveys and to provide information available at the central level. To facilitate the work of national counterparts, the questionnaires were pre-filled using all data available at WHO HQ before being sent out to countries. A coordinator was nominated for each of the 13 pilot countries. The coordinator for Pakistan was Dr Khalid Saeed Bukhari. The completed questionnaires were then used to produce the country profiles. In order to do this in a structured and efficient manner, a text template was developed. Member states took part in the development of the profile and, once the final product was ready, an officer from the Ministry of Health certified the quality of the information and gave formal permission to publish the profile on the web site of WHO. This profile will be regularly updated by country teams. If you have any suggestions on corrections to make please send them to Dr Khalid Saeed Bukhari, bukharik@pak.emro.who.int, WHO Country Office, Park Road, Islamabad.

Pakistan. Pharmaceutical Country Profile

Section 1 - Health and Demographic Data

This section gives an overview of the demographics and health status of Pakistan.

1.1 Demographics and Socioeconomic Indicators The total population of Pakistan in 2008 was 176,952,000 [1] with an annual population growth rate of 2.2%. The annual GDP growth rate is 6.0%. The GNI per capita is US$ 980 [2].

1.2 Mortality and Causes of Death The life expectancy at birth for men is 63 years and for women is 64 years. The infant mortality rate is 73/1,000 live births. For children under the age of 5, the mortality rate is 90/1,000 live births. The maternal mortality rate is 320/100,000 live births [1].

Section 2 - Health Services

This section provides information regarding health expenditure and human resources in Pakistan. The contribution of the public and private sector to overall health expenditure is shown and the specific information on pharmaceutical expenditure is also presented. Data on human resources for health and for the pharmaceutical sector is provided as well.

2.1 Health Expenditures In Pakistan, the total annual expenditure on health (THE) in 2008 was PKR 299,651 million (US$ 3,934 million). The total health expenditure is 2.9% of the GDP. The annual expenditure on health per capita was PKR 1,828 (US$ 24). The government1 annual expenditure on health accounts for 29.7% of the total expenditure on health, with a total per capita public expenditure on health of PKR 543 (US$ 7).The government annual expenditure on health represents 3.3% of the total government budget. The private health expenditure covers the remaining 70.3% of the total health expenditure. The total pharmaceutical expenditure (TPE) in Pakistan for 2007 was PKR 112,000 million (US$ 1,844 million). The pharmaceutical expenditure per capita was PKR 683 (US$ 11.3). The pharmaceutical expenditure accounts for 1.29% of the GDP and makes up 47.28% of the total health expenditure (figure 1) [3].

According to the NHA definition, by "government expenditure" it is meant all expenditure from public sources, like central government, local government, insurance funds and parastatal companies.

Pakistan. Pharmaceutical Country Profile Public expenditure on pharmaceuticals represents 27.1 %2 of the total expenditure on pharmaceuticals (figure 2). The public expenditure on pharmaceuticals per capita in 2004 was PKR 118.6 (US$ 2.04).
FIGURE 1: Share of Total Pharmaceutical Expenditure as percentage of the Total Health Expenditure in 2007.

47% 53%

TPE Other

Source: NHA 2007

FIGURE 2: Share of public and private sector to Total Pharmaceutical Expenditure (2004)

27%

Public sector Private sector

73%

Source: 2004 World Medicines Report

The share of public expenditure in pharmaceuticals as a percentage of the TPE is based on

data from 2004. Any calculations involving separate public and private pharmaceutical expenditures are therefore based on 2004 data.

The total private expenditure on pharmaceuticals in 2004 was PKR 51,759 million (US$ 888.18 million) [3] [4]. The annual growth rate of the total pharmaceuticals market value in 2009 was 17%. The annual growth rate of the generic pharmaceuticals market value in 2009 was 20% [5].

2.2 Health Personnel The health workforce is described in the table below and in figure 3 (and 4). Licensed pharmacists (all sectors) Pharmacists in the public sector Pharmaceutical technicians and assistants (all sectors) Physicians (all sectors) Nursing and midwifery personnel (all sectors) 7.8/10,000 [5] 2.89/10,000 [1] 0.61/10,000 0.092/10,000 1.22/10,000 [6]

Figure 3: The density of the Health Workforce in Pakistan

Nursing and midwifery personnel

Physicians

Pharmacists

10

/10,000 population

Pakistan. Pharmaceutical Country Profile

Figure 4: Distribution on Pharmaceutical Personnel in 2010

33%

Pharmacists

67%

Pharmceutical technicians and assistants

Source: Pharmacy Council, 2010

In Pakistan, there is a strategic plan for pharmaceutical human resource development in place [6].

2.3 Health Infrastructure The health centre and hospital statistics are described in the table below. Hospitals Hospital beds Primary health care units and centres Licensed pharmacies 0.058/10,000 10/10,000 0.33/10,000 0.43/10,000 [1] [5]

In Pakistan medicines are mostly dispensed through medical stores and less so through pharmacies [6].

Section 3 - Policy Issues

This section addresses the main structure of the pharmaceutical policy in Pakistan. Information about the capacity for manufacturing medicines and regulations regarding patents is also provided.

3.1 Policy Framework In Pakistan, a National Health Policy (NHP) exists. It was updated in 2001 [7]. An official National Medicines Policy document exists in Pakistan. It was updated in 1997. The NMP covers: Selection of essential medicines Medicines financing Medicines pricing Procurement Distribution Regulation Pharmacovigilance, Rational use of medicines Human resource development Research Monitoring and evaluation Traditional Medicine

Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

A NMP implementation plan does not exist. Access to essential medicines/technologies as part of the fulfillment of the right to health, is recognized in the constitution or national legislation [8]. There are official

Pakistan. Pharmaceutical Country Profile written guidelines on medicines donations. The pharmaceutical policy implementation is not being regularly monitored [5]. There is a formal code of conduct for public officials [9]. There is a whistleblowing mechanism allowing individuals to raise a concern about wrongdoing occurring in the pharmaceutical sector of Pakistan. This is through the Central Licensing and Registration Board, Quality Control Board, Price Review Board and the Consumer Right Protection Organization [10].

3.2 Intellectual Property Laws and Medicines Pakistan is a member of the World Trade Organization [11]. The country has a patent law. National Legislation has been modified to implement the TRIPS Agreement. Pakistan is eligible for the transitional period to 2016. Current laws contain the following (TRIPS) flexibilities and safeguards: Compulsory licensing provisions that can be applied for reasons of public health Bolar exceptions Parallel importing provisions

Yes Yes Yes

The country is engaged in initiatives to strengthen capacity to manage and apply intellectual property rights to contribute to innovation and promote public health [12]. There are no legal provisions for data exclusivity for pharmaceuticals. Legal provisions do not exist for patent extension. Laws do not exist for linkage between patent status and marketing authorization [10].

3.3 Manufacturing There are 478 licensed pharmaceutical manufacturers in Pakistan. Pakistan has the capacity for:

The R&D for discovering new active substances The production of pharmaceutical starting materials (APIs) The production of formulations from pharmaceutical starting material The repackaging of finished dosage form

Yes Yes Yes Yes

The percentage of market share by value produced by domestic manufacturers is 47% [5].

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Pakistan. Pharmaceutical Country Profile

Section 4 - Regulation
This section covers a broad range of pharmaceutical regulatory policy, institutions and practices in Pakistan

4.1 Regulatory Framework In Pakistan, there are legal provisions establishing the powers and responsibilities of the Medicines Regulatory Authority (MRA). The MRA is a part of the MoH. It has its own website. The URL address is http://www.dcomoh.gov.pk. The MRA is involved in harmonization/collaboration initiatives. These include WHO and the ECO. An assessment of the medicines regulatory system has not been conducted in the last five year [5].

4.2 Marketing Authorization In Pakistan, legal provisions require a marketing authorization (registration) for all pharmaceutical products on the market [13]. Explicit and publicly available criteria exist for assessing applications for marketing authorization of pharmaceutical products. The number of pharmaceutical products registered in Pakistan is 50,000. Legal provisions require the MRA to make the list of registered pharmaceutical products publicly available. Currently, the existing data is under the process of computerization. Medicines are registered by their INN (International Non-proprietary Names) or Brand name + INN. Legal provisions require a fee to be paid for Medicines Market Authorization (registration) based on applications [10].

4.3 Regulatory Inspection In Pakistan, there are legal provisions allowing for appointment of government pharmaceutical inspectors [14]. The Regulatory Authority has 305 inspectors. Legal provisions exist permitting inspectors to inspect premises where pharmaceutical activities are performed and requiring inspection to be 11

performed. Inspection is a pre-requisite for licensing facilities. Inspection requirements are the same for public and private facilities. All international standards are followed and implemented to provide safe, qualitative & effective medicines to the community [10].

4.4 Import Control Legal provisions exist requiring authorization to import medicines [15]. Laws exist that allow the sampling of imported products for testing. Legal provisions exist requiring importation of medicines through authorized ports of entry. Regulations or laws exist to allow for inspection of imported pharmaceutical products at the authorized port of entry [10].

4.5 Licensing In Pakistan, there are legal provisions requiring manufacturers to be licensed and requiring manufacturers to comply with Good Manufacturing Practices (GMP) [8] [16] [17]. Good Manufacturing Practices have been published by the government. Legal provisions exist requiring importers, wholesalers and distributors to be licensed [15]. Legal provisions exist requiring wholesalers and distributors to comply with Good Distributing Practices. Good Distribution Practices have been published by the government. There are legal provisions requiring pharmacists to be registered and requiring private pharmacies to be licensed [18]. National Good Pharmacy Practice Guidelines are not published by the government [10].

4.6 Market Control and Quality Control In Pakistan, there are legal provisions for controlling the pharmaceutical market. A laboratory exists in Pakistan for Quality Control testing. Samples are collected by government inspectors for undertaking post-marketing surveillance testing. In the past 2 years, 60,000 samples were taken for quality control testing. 1,194 of the samples tested failed to meet the quality standards. The results are not publicly available [10].

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Pakistan. Pharmaceutical Country Profile

4.7 Medicines Advertising and Promotion In Pakistan, legal provisions exist to control the promotion and/or advertising of prescription medicines. The Drug Control Organization is responsible for regulating promotion and/or advertising of medicines. There are legal provisions prohibiting direct advertising of prescription medicines to the public and requiring a pre-approval for medicines advertisements and promotional materials. Guidelines/Regulations exist for advertising and promotion of nonprescription medicines. A national code of conduct exists concerning advertising and promotion of medicines by marketing authorization holders. Adherence to it is voluntary. The code contains a formal process for complaints and sanctions. The list of the complaints and sanctions for the last two years is not publicly available [19] [10].

4.8 Clinical Trials In Pakistan, there are legal provisions requiring authorization for conducting Clinical Trials by the MRA. Laws require the agreement by an ethics committee or institutional review board of the Clinical Trials to be performed. Registration of the clinical trials into a registry is required by law [20] [10].

4.9 Controlled Medicines Pakistan is signatory to the: - Single Convention on Narcotic Drugs, 1961 - 1972 Protocol amending the Single Convention on Narcotic Drugs, 1961 - Convention on Psychotropic Substances 1971 - United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988 Laws exist for the control of narcotic and psychotropic substances, and precursors. The annual consumption of Morphine is 0.006 mg/capita [21] [22].

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4.10 Pharmacovigilance In Pakistan, there are legal provisions requiring the Marketing Authorization holder to continuously monitor the safety of their products and report to the MRA. Laws about monitoring Adverse Drug Reactions (ADR) exist in Pakistan. A national Pharmacovigilance centre linked to the MRA does not exist in Pakistan. An official standardized form for reporting ADRs is used in Pakistan [23]. A national ADR database does not exist in Pakistan. In the past 2 years, no ADR reports are sent to the WHO database in Uppsala. ADRs are not monitored in public health programs (example TB, HIV/AIDS) [10].

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Pakistan. Pharmaceutical Country Profile

Section 5 - Medicines Financing

In this section, information is provided on the structure of user fees for medicines and on the existence of public programmes providing free medicines. Policies and regulations in place that affect the prices of medicines (e.g. price control and taxes) are presented.

5.1 Medicines Coverage and Exemptions In Pakistan, there are public programmes providing free medicines to: Patients who cannot afford them Children under 5 Pregnant women Elderly persons

Yes Yes Yes Yes

Legal provisions exist, but are not implemented due to financial restraints. Public programmes exist providing free medicines for: All diseases Any non-communicable diseases Malaria Tuberculosis Sexually transmitted diseases HIV/AIDS EPI Vaccines for children (expanded programme of immunization)

Yes Yes Yes Yes Yes Yes Yes

In Pakistan, there is a public health service, public health insurance, social insurance or other sickness fund that provides at least partial medicines

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coverage. It provides coverage for medicines that are on the Essential Medicines List (EML) for inpatients and outpatients. Private health insurance schemes provide medicines coverage. They are not required to provide at least partial coverage for medicines that are on the EML. Private insurers offer full reimbursement for medicines, but they are not obliged to follow the EML [5] [10].

5.2 Patients Fees and Copayments In the public sector of Pakistan, at the point of delivery, there are no copayments/fee requirements for consultations and for medicines. Yet, in the private sector there might be variable fees. Revenue from fees or from the sale of medicines is not used to pay the salaries or supplement the income of public health personnel in the same facility [5] [10].

5.3 Pricing Regulation for the Private Sector (not including the non-profit voluntary sector) In Pakistan, there are legal or regulatory provisions affecting pricing of medicines [24]. These provisions are aimed at the level of manufacturers, wholesalers and retailers. The government runs an active national medicines price monitoring system for retail prices. Regulations exist mandating that retail medicine price information should be publicly accessible. The information is made publically available through the Official Gazette Notification.

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Pakistan. Pharmaceutical Country Profile 5.4 Prices, Availability and Affordability of Key Medicines In 2004, a WHO/HAI pricing survey was conducted in Pakistan. In public sector, median availability of originator medicines was 0% and availability of generic medicines was 3.3%. The private sector had higher availability (54.2% for originator and 31.3% for generics). Prices of medicines have been compared to international reference prices3 and expressed as a ratio of the international price (e.g. a price ratio of 2 would mean that the price is two times the international reference price). Since prices have been collected for a basket of medicines, the median price ratio has been selected to represent the situation in the country. Public procurement prices were below international reference prices (IRP) for generics and above IRP for originators: the Median Price Ratio for originators was 2.24 and for generics 0.57. As for patient prices, the private sector had higher prices (3.36 for originators and 2.26 for generics). Affordability of medicines is measured in terms of number of days of wage necessary to purchase treatment for a condition. The wage is the one of the lowest paid government worker. In the public sector of Pakistan, the treatment with co-trimoxazole for a child respiratory infection is for free. In the private sector, it would take 0.3 days of wage to purchase treatment using generic medicines and 0.4 days using originators [25].

5.5 Duties and Taxes on Pharmaceuticals (Market) There are duties on imported raw materials (10%) and imported finished products (10%). There is however no value-added tax or any other tax on pharmaceuticals [26].

The International reference price is the median of prices offered by international suppliers (both for profit and not profit) as report by MHS International Price Indicator Guide (http://erc.msh.org/mainpage.cfm?file=1.0.htm&module=DMP&language=English). For more information on the methodology WHO/HAI pricing survey, you can download a free copy of the manual at http://apps.who.int/medicinedocs/documents/s14868e/s14868e.pdf.

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Section 6 - Pharmaceutical procurement and distribution in the public sector

This section provides a short overview on the procurement and distribution of pharmaceuticals in the public sector of Pakistan.

6.1 Public Sector Procurement The public sector procurement in Pakistan is centralized and decentralized. It is centralized under the responsibility of a procurement agency that is part of the MoH. The public sector tender bids are publicly available and public sector awards are publicly available. Procurements are based on prequalification of suppliers. Medical Store Depots in provinces call quotations from a list of prequalified companies [5] [10].

6.2 Public Sector Distribution The government supply system department in Pakistan has not a Central Medical Store at a National Level, but there are stores at a district level. There are national guidelines on Good Distribution Practices (GDP). There is a licensing authority that issues GDP licenses. The licensing authority does accredit public distribution facilities. Lists of GDP certified warehouses and distributors do not exist in the public sector [5] [10].

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Pakistan. Pharmaceutical Country Profile

Section 7 - Selection and rational use of medicines

This section presents the structures and policies that are in place in Pakistan for selection of essential medicines and promotion of rational drug use.

7.1 National Structures National Standard Treatment Guidelines (STGs) for the most common illnesses have been produced/endorsed by the MoH in Pakistan. The national STGs were updated in 2006. A National Essential Medicines List (EML) exists in Pakistan and it was lastly updated in 2007 [27]. There are 345 of medicines on the EML. No public or independently funded national medicines information centre provides information on medicines to prescribers, dispensers and consumers. Public education campaigns on rational medicine use topics have not been conducted in the last two years. A survey on rational use of medicines has not been conducted in the previous two years. A national programme or committee, involving government, civil society, and professional bodies, does not exist to monitor and promote rational use of medicines. A written National Strategy to contain antimicrobial resistance does not exist [5] [10].

7.2 Prescribing Legal provisions in Pakistan exist to govern the licensing and prescribing practices of prescribers. Legal provisions do not exist to restrict dispensing by prescribers. There are no regulations requiring hospitals to organize/develop Drug and Therapeutics Committees (DTCs). The core medical, nursing and paramedical training curricula include components on: The concept of EML Use of STGs Pharmacovigilance Problem based pharmacotherapy

No No No No

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Mandatory continuing education that includes pharmaceutical issues is not required for doctors, nurses and paramedical staff. Prescribing by INN name is not obligatory in the public and private sector [28]. The average number of medicines prescribed per patient contact in public health facilities is 2.85 [29].

7.3 Dispensing Legal provisions in Pakistan exist to govern dispensing practices of pharmaceutical personnel. The core pharmacist training curriculum includes components on: The concept Use of STGs Drug information Clinical Pharmacy Medicine Supply Management

Yes Yes Yes Yes Yes

Mandatory continuing education that includes pharmaceutical issues is not required for pharmacists. Substitution of generic equivalents at the point of dispensing is allowed in public sector facilities, but not in the private sector. Antibiotics are sold overthe-counter without a prescription. Injectable medicines are sold over-thecounter without a prescription [30].

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Pakistan. Pharmaceutical Country Profile

Section 8 - Household data/access

This section provides information about household surveys held in the past in Pakistan regarding actual access to medicines by normal and poor households. In Pakistan, 91.2% of adult patients with an acute condition took all medicines prescribed. of the patients not taking all medicines, 68% did not because they could not afford them. Of adult patients with an acute condition coming from poor households, 89.4% took all the medicines prescribed. Of patients not taking all medicines, 66.9% did not because they could not afford them. Of adult patients with chronic conditions, 83.8 % took all medicines prescribed. Of adult patients with chronic conditions coming from a poor household, 70.5% took all medicines prescribed. Of the patients not taking all medicines, 37.5% did not because they could not afford them. Of children with an acute condition coming from poor household, 85.5% took all medicines prescribed [31].

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References
[1] World Health Statistics. Geneva, World Health Organization, 2010. Available through the Global Health Observatory: http://apps.who.int/ghodata/, 20-072010. [2] Country data, Pakistan. Washington, the World Bank, 2008. Available at: http://data.worldbank.org/country/pakistan, 21-07-2010. [3] National health accounts: country information Pakistan. Geneva, World Health Organization, 2008. Available at: http://www.who.int/nha/country/pak/en/, 21-07-2010. [4] Lowe RF, Montagu D. Legislation, regulation, and consolidation in the retail pharmacy sector in low income countries. Southern Med Review (2009) 2; 2:3544 [5] The Federal Ministry of Health of Pakistan, Islamabad. Website available at: http://202.83.164.26/wps/portal/Moh, 21-07-2010. [6] Pharmacy Council of Pakistan, Islamabad. [7] National health policy 2001, the way forward. Islamabad, Ministry of Health; Government of Pakistan, 2001. Available at: LINK, DATE [8] National drug policy. Islamabad, Drugs Control Organization; Ministry of Health of Pakistan, 1997. Available at: http://www.dcomoh.gov.pk/publications/ndp.php, 21-07-2010. [9] Civil service of Pakistan, Islamabad. Website available at: http://www.css.com.pk, 21-07-2010. [10] Drugs Control Organization; Ministry of Health of Pakistan, Islamabad. Website available at: http://www.dcomoh.gov.pk/, 21-07-2010. [11] International trade statistics. Geneva, World Trade Organization, 2009. Available at: http://www.wto.org/english/res_e/statis_e/its2005_e/its05_toc_e.htm, 2107-2010. [12] Intellectual property organization of Pakistan, Islamabad. Website available at: http://www.ipo.gov.pk/, 21-07-2010.

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Pakistan. Pharmaceutical Country Profile [13] Registration of drugs; Drug Act 1976. [14] The Drugs Rules, 1976 (federal inspectors, federal drug laboratory and federal government analysts). [15] The Drugs Rules, 1976 (import and export). [16] Regulation of manufacture of drugs, DRUG ACT, 1976. [17] The Drugs Rules (Licensing Registering and Advertising) 1976. [18] Pharmacy Act, 1967. PLACE. [21] Report of the International Narcotics Control. Vienna, International Narcotics Control Board, 2009. Available at: www.incb.org, 08-06-2010. [22] Anti narcotics policy 2010. Islamabad, Narcotics Control Division; Ministry of Narcotics Control, Government of Pakistan, 2010. [23] Adverse drug reaction reporting form. Islamabad, Ministry of Health. [24] Price review committee. Islamabad, Ministry of Health Pakistan, 1999. [25] Prices, availability and affordability of medicines in Pakistan. Islamabad, the Network for Consumer Protection, 2006. Available at: http://www.haiweb.org/medicineprices/surveys/200407PK/survey_report.pdf, 21-07-2010. [26] Notification customs. Islamabad, Government of Pakistan; Ministry of Finance, Economic Affairs, statistics & revenue, 2006. [27] National essential medicines list of Pakistan. Islamabad, Ministry of Health; Government of Pakistan, 2007. [26] Drug Act; Advertising of Drugs, 1976. [27] The Drugs Rules (Research), 1978. [28] Pakistan Medical & Dental Council, Islamabad. Available at: http://www.pmdc.org.pk/, 21-07-2010. [29] Rational use survey Pakistan. [30] Zahid A. Butt, Anwar H. Gilani. Quality of pharmacies in Pakistan: a cross-sectional survey. International Journal for Quality in Health Care 2005; Volume 17, Number 4: pp. 307313

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[31] World health survey, report of Pakistan. WHO Regional office for the Eastern Mediterranean (EMRO), 2003. Available at: http://www.who.int/healthinfo/survey/whspak-pakistan.pdf, 21-07-2010

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Pakistan. Pharmaceutical Country Profile

Pakistan Pharmaceutical Country Profile

ANNEX
Survey Data

25

Respondents to the questionnaire: Syed Khalid Saeed Bukhari +92-(0)300-4005935 bukharik@pak.emro.who.int Sheikh Ansar Ahmad +92-(0)51-9202566 Sh.shaikh2001@yahoo.com Mr. Arshad Khan Dr. Rasheed 0092-(0)51-9203943 rashiddyk@yahoo.com

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Pakistan. Pharmaceutical Country Profile

Section 1 Health and Demographic data

1.01 Demographic and Socioeconomic Indicators Core Questions Population, total (,000) Population growth rate (Annual %) GDP growth (Annual %) GNI per capita (US$ current exchange rate) Supplementary questions Population < 15 years (% of total population) Population > 60 years (% of total population) Urban population (% of total population) Fertility rate, total (Births per woman) Population living with less than $1/day (international PPP) (%) Population living below nationally defined poverty line (%) Adult literacy rate, 15+ years (% of total population) 1.02 Mortality and Causes of Death Core questions Life expectancy at birth for men (Years) Life expectancy at birth for women (Years) Infant mortality rate, between birth and age 1 (/1,000 live births) Under 5 mortality rate (/1,000 live births) Maternal mortality ratio (/100,000 live births) Supplementary questions Adult mortality rate for both sexes between 15 and 60 years (/1,000 population) Neonatal mortality rate (/1,000 live births) Age-standardized mortality rate by non-communicable diseases 163,902 2.2 6.0 980 2007 2008 2008 2008 World Health Statistics World Bank, Population World Bank World Bank

36 6 36 3.5 22.6 9.1 54.9

2007 2007 2007 2007 2005 2005 2007

World Health Statistics World Health Statistics World Health Statistics World Health Statistics World Health Statistics World Bank World Health Statistics

63 64 73

2007 2007 2007

World Health Statistics World Health Statistics World Health Statistics World Health Statistics World Health Statistics World Health Statistics World Health Statistics World Health Statistics

90 320

2007 2005

204

2007

53 717

2004 2004

27

( /100,000 population) Age-standardized mortality rate by cardiovascular diseases (/100,000 population) Age-standardized mortality rate by cancer ( /100,000 population) Mortality rate for HIV/AIDS (/100,000 population) Mortality rate for tuberculosis (/100,000 population) Mortality rate for Malaria (/100,000 population) 409 2004 World Health Statistics World Health Statistics World Health Statistics World Health Statistics World Health Statistics

103 3 28 1

2004 2007 2007 2006

Section 2 Health Services

2.01 Health Expenditures Core Questions Total annual expenditure on health (millions US$ average exchange rate) Total annual expenditure on health (millions NCU) Total health expenditure as % of Gross Domestic Product Total annual expenditure on health per capita (US$ average exchange rate) Total annual expenditure on health per capita (NCU) General government annual expenditure on health (millions US$ average exchange rate) General government annual expenditure on health (millions NCU) Government annual expenditure on health as percentage of total government budget (% of total government budget) Government annual expenditure on health as % of total expenditure on health (% of total expenditure on health) Annual per capita government expenditure on health (US$ average exchange rate) Annual per capita government expenditure on health (NCU) Private health expenditure as % of 3,934 2008 Calculated for the NHA National Health Accounts NHA NHA

299,651 2.9 24

2008 2008 2008

1,828 1,147

2008 2008

Calculated for the NHA Calculated for the NHA NHA NHA

88,934 3.3

2008 2008

29.7

2008

NHA

2008

NHA

543 70.3

2008 2008

Calculated for the NHA NHA

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Pakistan. Pharmaceutical Country Profile

total health expenditure (% of total expenditure on health) Total pharmaceutical expenditure (millions US$ current exchange rate) Total pharmaceutical expenditure (millions NCU) Total pharmaceutical expenditure per capita (US$ current exchange rate) Total pharmaceutical expenditure per capita (NCU) Pharmaceutical expenditure as a % of GDP (% of GDP) Pharmaceutical expenditure as a % of Health Expenditure (% of total health expenditure) Share of public expenditure on pharmaceuticals as percentage of total expenditure on pharmaceuticals (%) Annual growth rate of total pharmaceuticals market value (%) Annual growth rate of generic pharmaceuticals market value (%) Supplementary Questions Social security expenditure as % of government expenditure on health (% of government expenditure on health) Private out-of-pocket expenditure as % of private health expenditure (% of private expenditure on health) 1,844 112,000 11.3 683 1.29 47.28 2008 2007 2007 2007 2007 2007 Calculated for the NHA NHA Calculated for the NHA Calculated for the NHA Calculated for the NHA Calculated for the NHA World Medicines Situation Report

27.1

2004

17 20

2009 2009

MoH MoH

4.4

2008

NHA

82.4

2008

NHA

Premiums for private prepaid health 0.3 plans as % of total private health expenditure (% of private expenditure on health) 2.02 Health Personnel and Infrastructure Core Questions Total number of pharmacists licensed/registered to practice in your country Total number of pharmacists working in the public sector Total number of pharmaceutical technicians and assistants A strategic plan for pharmaceutical human resource development is in place in your country? Total number of physicians Total number of nursing and 10,000

2008

NHA

2010

Pakistan Pharmacy Council Pakistan Pharmacy Council Pakistan Pharmacy Council Pakistan Pharmacy Council MoH WHS

1,500 20,000 Yes

2010 2010 2010

127,893 47,380

2009 2005

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midwifery personnel Total number of hospitals Total number of hospitals bed Total number of primary health care units and centres Total number of licensed pharmacies Comments Supplementary Questions Starting annual salary for a newly registered pharmacist in the public sector - NCU Are there accreditation requirements for pharmacy schools? Is the Pharmacy Curriculum regularly reviewed? 15,000 2010 Pakistan Pharmacu Council 965 163,902 5,467 7,000 2010 2007 2010 2009 MoH WHS MoH MoH

In Pakistan mostly medical store exists and few pharmacies

Yes Yes

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Pakistan. Pharmaceutical Country Profile

Section 3 Policy issues

3.01 Policy Framework Core Questions National Health Policy exists. If yes, please write year of the most recent document in the "year" field. National Medicines Policy official document exists. If yes, please write the year of the most recent document in the "year" field. Group of policies addressing pharmaceuticals exist. National Medicines Policy covers the following components: Selection of Essential Medicines Medicines Financing Medicines Pricing Medicines Procurement Medicines Distribution Medicines Regulation Pharmacovigilance Rational Use of Medicines Human Resource Development Research Monitoring and Evaluation Traditional Medicine National medicines policy implementation plan exists. If yes, please write year of the most recent document in the "year" field. Access to essential medicines/technologies as part of the fulfillment of the right to health, recognized in the constitution or national legislation? There are official written guidelines on medicines donations. Please attach document or provide URL below * Is pharmaceutical policy implementation being regularly monitored/assessed? Is there a national good governance policy? Multisectoral Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No Yes 2001 MoH

Yes

1997

MoH

Yes

1997

MoH

Yes

1997

MoH

Yes

2005

MoH

No

Unknown No

31

For the pharmaceutical sector

No

A policy is in place to manage and sanction conflict of interest issues in pharmaceutical affairs. There is a formal code of conduct for public officials. Is there a whistle-blowing mechanism allowing individuals to raise a concern about wrongdoing occurring in the pharmaceutical sector of your country (ombudsman)? Please describe:

Unknown

Yes Yes

2009 1976

Civil Service of Pakistan Drug Control Organization

Through Central Licensing and Registration Board, Quality Control Boar, Price Review Board and Consumer right protection organization 3.02 Intellectual Property Laws and Medicines Core Questions Country is a member of the World Trade Organization Legal provisions provide for granting of Patents on pharmaceuticals Yes Yes 2009 2000 Int. Trade Statistics MoH/Intellectual Property Organization Pakistan MoH/Intellectual Property Organization Pakistan MoH/Intellectual Property Organization Pakistan Intellectual Property Organization Pakistan

National Legislation has been modified to implement the TRIPS Agreement Current laws contain (TRIPS) flexibilities and safeguards

Yes

2000

Yes

2000

Country is eligible for the transitional period to 2016 Which of the following (TRIPS) flexibilities and safeguards are present in the national law? Compulsory licensing provisions that can be applied for reasons of public health Bolar exception

Yes

2007

Yes

2000

MoH/Intellectual Property Organization Pakistan MoH/Intellectual Property Organization Pakistan MoH/Intellectual Property

Yes

2000

Are parallel importing provisions present in the national law?

Yes

2000

32

Pakistan. Pharmaceutical Country Profile

Organization Pakistan The country is engaged in initiatives to strengthen capacity to manage and apply intellectual property rights to contribute to innovation and promote public health Are there legal provisions for data exclusivity for pharmaceuticals Legal provisions exist for patent extension Legal provisions exist for linkage between patent status and marketing authorization Comments Yes 2000 MoH/Intellectual Property Organization Pakistan Drug Control Organization/ MoH Drug Control Organization/ MoH Drug Control Organization/ MoH

No No No

2010 2010 2010

The Words 'Bolar Exception' were not used in the official documents, but the concept of Bolar Exception exists

3.03 Manufacturing Core Questions Number of licensed pharmaceutical manufacturers in the country Country has manufacturing capacity for: R&D to discover new active substances Production of pharmaceutical starting materials (APIs) Production of formulations from pharmaceutical starting material Repackaging of finished dosage forms Percentage of market share by value produced by domestic manufacturers (%) Supplementary Questions Percentage of market share by volume produced by domestic manufacturers (%) Number of multinational pharmaceutical companies manufacturing medicines locally Number of manufacturers that are GMP certified Yes Yes Yes Yes 47 2009 MoH 478 2009 2010 MoH MoH

55

2009

MoH

20

2009

MoH

478

2009

MoH

33

Section 4 Regulation
4.01 Regulatory Framework Core Questions Are there legal provisions establishing the powers and responsibilities of the medicines regulatory authority? Part of MOH Semi autonomous agency The MRA has its own website - If yes, please provide MRA Web site address (URL) The MRA is involved in harmonization/ collaboration initiatives - If yes, please specify An assessment of the medicines regulatory system has been conducted in the last five years. Supplementary Questions Formal code of conduct exists for staff involved in medicines regulation Medicines Regulatory Authority gets funds from regular budget of the government. Medicines Regulatory Authority is funded from fees for services provided. Medicines Regulatory Authority receives funds/support from other sources - If yes, please specify Yes 2010 MoH

Yes No Yes www.dcomoh.gov.pk Yes 2010 MoH 2010 MoH

WHO, ECO No MoH

Yes Yes

2009 2009

MoH MoH

No

2009

MoH

Yes

2009

MoH

WHO JPRM for capacity building support No 2009 MoH

Revenues derived from regulatory activities are kept with the regulatory authority

The Regulatory Authority is using a No computerized information management system to store and retrieve information on registration, inspections, etc. 4.02 Marketing Authorization (Registration) Core Questions Legal provisions require a marketing authorization (registration) for all Yes

2009

MoH

2010

Drug Control Organization/MoH

34

Pakistan. Pharmaceutical Country Profile

pharmaceutical products on the market Explicit and publicly available criteria exist for assessing applications for marketing authorization of pharmaceutical products Number of pharmaceutical products registered in your country Legal provisions require the MRA to make publicly available the registered pharmaceutical with defined periodicity - If yes, how frequently updated Medicines are registered by their INN (International Non-proprietary Names) or Brand name + INN Legal provisions require paying a fee for Medicines Market Authorization (registration) applications Supplementary Questions Legal provisions require marketing authorization holders to provide information about variations to the existing marketing authorization Legal provisions require to publish the Summary Product Characteristics (SPCs) of the medicines registered Legal provisions require the establishment of an expert committee involved in the marketing authorization process Certificate for Pharmaceutical Products in accordance with the WHO Certification scheme is required as part of the marketing authorization application Legal provision require declaration of potential conflict of interests for the experts involved in the assessment and decision-making for registration Legal provisions allow applicants to appeal against MRAs decisions Registration fee - the amount per application for pharmaceutical product containing New Chemical Entity,NCE (US$) Registration fee - the Amount per application for a multisource pharmaceutical product (US$) Time limit for the assessment of a Yes 2010 Drug Control Organization/MoH

50,000 Yes

2010 2010

Drug Control Organization/MoH Drug Control Organization/MoH

Currently existing data is under process of computerization Yes 2010 Drug Control Organization/MoH Drug Control Organization/MoH

Yes

2010

Yes

2010

Drug Control Organization/MoH

Yes

2010

Drug Control Organization/MoH Drug Control Organization/MoH

Yes

2010

No

2010

Drug Control Organization/MoH

Yes

2010

Drug Control Organization/MoH

Yes 15,000

2010 2010

Drug Control Organization/MoH Drug Control Organization/MoH

8,000

2010

Drug Control Organization/MoH Drug Control

2010

35

marketing authorization application (Months) 4.03 Regulatory Inspection Core Questions Legal provisions exist allowing for appointment of government pharmaceutical inspectors Does the Regulatory Authority have inspectors? If yes, how many? Legal provisions exist permitting inspectors to inspect premises where pharmaceutical activities are performed Legal provisions exist requiring inspection to be performed Inspection is a pre-requisite for licensing of facilities Inspection requirements are the same for public and private facilities Comments Yes 2010

Organization/MoH

Drug Control Organization/MoH Drug Control Organization/MoH Drug Control Organization/MoH Drug Control Organization/MoH

Yes 305 Yes

2010 2010 2010

Yes Yes Yes

2010 2010 2010

Drug Control Organization/MoH Drug Control Organization/MoH Drug Control Organization/MoH

All internation standards are followed and implemented to provide safe quality & efficious drug to the community

4.04 Import Control Core Questions Legal provisions exist requiring authorization to import medicines Legal provisions exist allowing the sampling of imported products for testing Legal provisions exist requiring importation of medicines through authorized ports of entry Legal provisions exist allowing inspection of imported pharmaceutical products at the authorized port of entry 4.05 Licensing Core Questions Legal provisions exist requiring manufacturers to be licensed If yes please provide documents below. Please attach document or provide URL below * Legal provisions exist requiring manufacturers to comply with Good manufacturing Practices (GMP) GMP requirements are published by the government. If yes, please Yes Yes 2010 2010 Drug Control Organization/MoH Drug Control Organization/MoH Drug Control Organization/MoH Drug Control Organization/MoH

Yes

2010

Yes

2010

Yes

2010

Drug Control Organization/MoH

Yes

2010

Drug Control Organization/MoH Drug Control Organization/MoH

Yes

2010

36

Pakistan. Pharmaceutical Country Profile

provide reference or URL below * Legal provisions exist requiring importers to be licensed Legal provisions exist requiring wholesalers and distributors to be licensed Legal provisions exist requiring wholesalers and distributors to comply with Good Distributing Practices National Good Distribution Practice requirements are published by the government Legal provisions exist requiring pharmacists to be registered Legal provisions exists requiring private pharmacies to be licensed Legal provision exist requiring public pharmacies to be licensed National Good Pharmacy Practice Guidelines are published by the government Supplementary Questions Yes Yes 2010 2010 Drug Control Organization/MoH Drug Control Organization/MoH Drug Control Organization/MoH

Yes

2010

Yes

2010

Drug Control Organization/MoH Drug Control Organization/MoH Drug Control Organization/MoH Drug Control Organization/MoH Drug Control Organization/MoH

Yes Yes Unknown No

2010 2010 2010 2010

Legal provisions require the Yes publication of different categories of all pharmaceutical facilities licensed 4.06 Market Control and Quality Control Core Questions Legal Provisions for controlling the pharmaceutical market exist Does a laboratory exist in the country for Quality Control testing? If not, does the regulatory authority contract services elsewhere? Samples are collected by government inspectors for undertaking post-marketing surveillance testing How many Quality Control samples were taken for testing in the past two years? What is the total number of samples tested in the previous two years that failed to meet quality standards? Results of quality testing in past two years are publicly available Comments Yes Yes No Yes

2010

Drug Control Organization/MoH

2010 2010 2010 2010

Drug Control Organization/MoH Drug Control Organization/MoH Drug Control Organization/MoH Drug Control Organization/MoH

60,000

2010

Drug Control Organization/MoH Drug Control Organization/MoH Drug Control Organization/MoH

1,194

2010

No

2010

The DRUGS (FEDERAL INSPECTORS, FEDERAL DRUG LABORATORY and FEDERAL GOVERNMENT ANALYSTS) RULES, 1976, cover all issues in this section.

37

4.07 Medicines Advertising and Promotion Core Questions Legal provisions exist to control the promotion and/or advertising of prescription medicines Who is responsible for regulating, promotion and/or advertising of medicines? Please describe: Legal provisions prohibit direct advertising of prescription medicines to the public Legal provisions require a preapproval for medicines advertisements and promotional materials Guidelines/Regulations exist for advertising and promotion of nonprescription medicines A national code of conduct exists concerning advertising and promotion of medicines by marketing authorization holders and is publicly available If yes, the code of conduct applies to domestic manufacturers only, multinational manufacturers only, or both If yes, adherence to the code is voluntary If yes, the code contains a formal process for complaints and sanctions If yes, list of complaints and sanctions for the last two years is publicly available Comments 4.08 Clinical trials Core Questions Legal provisions exist requiring authorization for conducting Clinical Trials by the MRA Legal provisions exist requiring the agreement by an ethics committee/ institutional review board of the Clinical Trials to be performed Legal provisions exist requiring registration of the clinical trials into international/national/regional registry Supplementary Questions Legal provisions exist for GMP Yes 2010 Drug Organization/MoH Drug Organization/MoH Yes 2010 Drug Organization/MoH

Drug Control Organization, MoH, under Drug (Advertising) Rules, 1976 Yes 2010 Drug Organization/MoH Drug Organization/MoH

Yes

2010

Yes

2010

Drug Organization/MoH Drug Organization/MoH

Yes

2010

Yes

2010

Drug Organization/MoH

Yes Yes No

2010 2010 2010

Drug Organization/MoH Drug Organization/MoH Drug Organization/MoH

The Drug (Advertising) Rules, 1976, cover all the issues discussed in this section.

Yes

2010

Yes

2010

Drug Organization/MoH

Yes

2010

Drug

38

Pakistan. Pharmaceutical Country Profile

compliance of investigational products Legal provisions require sponsor, investigator to comply with Good Clinical Practices (GCP) National GCP regulations are published by the Government. Legal provisions permit inspection of facilities where clinical trials are performed Comments 4.09 Controlled Medicines Core Questions The country is a signatory to conventions Single Convention on Narcotic Drugs, 1961 The 1972 Protocol amending the Single Convention on Narcotic Drugs, 1961 Convention on Psychotropic Substances 1971 United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988 Laws for the control of narcotic and psychotropic substances, and precursors exist. Annual consumption of Morphine (mg/capita) Supplementary Questions The laws and regulations for the control of narcotic and psychotropic substances, and precursors has been reviewed by a WHO International Expert or Partner Organization to assess the balance between the prevention of abuse and access for medical need If yes, year of review. Please attach a copy of the review or provide link to it if available on the web * Annual consumption of Fentanyl (mg/capita) Annual consumption of Pethidine (mg/capita) Annual consumption of Oxycodone (mg/capita) Yes 2009 International Narcotics Control Board INCB Yes 2010 Organization/MoH Drug Organization/MoH Drug Organization/MoH Drug Organization/MoH

Yes Yes

2010 2010

Drugs (Research) Rules, 1978, cover all the issues discussed in this section.

Yes

2009

Yes Yes

2009 2009

INCB INCB

Yes

2009

Ministry of Narcotic Control INCB

0.006

2007

Yes

2010

MoH

National Anti Narcotic Policy 0.0018 0.006 0.00045 2009 2009 2009 MoH MoH MoH

39

Annual consumption of Phenobarbital (mg/capita) 4.10 Pharmacovigilance Core Questions There are legal provision in the Medicines Act that provides for pharmacovigilance activities as part of the MRA mandate Legal provisions exist requiring the Marketing Authorization holder to continuously monitor the safety of their products and report to the MRA Legal provisions about monitoring Adverse Drug Reactions (ADR) exist in your country A national Pharmacovigilance centre linked to the MRA exists in your country If a national pharmacovigilance center exists in your country, an analysis report has been published in the previous two years. Please attach document or provide URL below * If a national pharmacovigilance center exists in your country, it publishes an ADR bulletin An official standardized form for reporting ADRs is used in your country. If yes, please attach document below * A national Adverse Drug Reactions database exists in your country. Are ADR reports set to the WHO database in Uppsala? ADRs are monitored in at least one public health program (for example TB, HIV, AIDS)? Supplementary Questions Feedback is provided to reporters The ADR database is computerized Medications errors (MEs) are reported. There is a risk management plan presented as part of product dossier submitted for Marketing Authorization? In the past two years, who has reported ADRs? Doctors

0.0106

2008

MoH

Unknown

Yes

2010

Drug Control Organization/MoH

Yes

2010

MoH

No

No

No

Yes

2010

MoH

No No No

No No No No

Yes

40

Pakistan. Pharmaceutical Country Profile

Nurses Pharmacists Consumers Pharmaceutical Companies Was there any regulatory decision based on local PV data in the last 2 years? Are there training courses in Pharmacovigilance? If yes, how many people have been trained in the past two years? Comments Yes Yes Yes Yes No

Yes 300

MoH MoH

Ministry of Health is working on the proposal of establishing the Pharmacovigilance Center in Pakistan, training on Pharmacovigilance was conducted in collaboration with WHO through JPRM

41

Section 5 Medicines Financing

5.01 Medicines Coverage and Exemptions Core Questions If a public programme providing free medicines exists, medicines are available free-of-charge for: Patients who cannot afford them Children under 5 Pregnant women Elderly persons Please describe/explain your yes answers for questions above If a public programme providing some/all medicines free exists, the following types of medicines are free All medicines for all conditions Any non-communicable diseases Malaria medicines Tuberculosis medicines Sexually transmitted diseases medicines HIV/AIDS medicines EPI vaccines Does a public health service, public health insurance, social insurance or other sickness fund provides at least partial medicines coverage Does it provide coverage for medicines that are on the EML for inpatients Does it provide coverage for medicines that are on the EML for outpatients Does it provide at least partial medicines coverage for inpatients Does it provide at least partial medicines coverage for outpatients Do private health insurance schemes provide any medicines coverage? If yes, is it required to provide at least partial coverage for medicines that are on the EML? Comments Yes Yes Yes Yes Yes Yes Yes Yes 2009 2009 2009 2009 2009 2009 2009 2009 MoH MoH MoH MoH MoH MoH MoH MoH Yes Yes Yes Yes 2009 2009 2009 2009 MoH MoH MoH MoH

Legal provision exists, but are actually not implemented due to financial constraints

Yes Yes Yes Yes Yes No 2009 MoH

Private insurers offer full reimbursement for medicines, but they are obliged to follow the EML

42

Pakistan. Pharmaceutical Country Profile

5.02 Patients Fees and Copayments Core Questions In your health system, at the point of delivery, are there any copayment/fee requirements for consultations In your health system, at the point of delivery, are there any copayment/fee requirements for medicines Is revenue from fees or from the sale of medicines used to pay the salaries or supplement the income of public health personnel in the same facility No 2009 MoH

No

2009

MoH

No

2009

MoH

Please describe the patient fees and In the public sector there are no fees, in the private copayments system sector there are variable fees 5.03 Pricing Regulation for the Private Sector Core Questions Are there legal or regulatory provisions affecting pricing of medicines If yes, are the provisions aimed at Manufacturers If yes, are the provisions aimed at Wholesalers If yes, are the provisions aimed at Retailers Government runs an active national medicines price monitoring system for retail prices Regulations exists mandating that retail medicine price information should be publicly accessible Yes 2009 MoH

Yes Yes Yes Yes

2009 2009 2009 2009

MoH MoH MoH MoH

Yes

2009

MoH

-if yes, please explain how the Official Gazzette Notification information is made publically available 5.04 Prices, Availability and Affordability Core Questions Please state if a medicines price survey using the WHO/HAI methodology has been conducted in the past 5 years in your country. Yes

Basket of key medicines Availability (one or both of) Mean (%) Orig. LPG

Public procurem ent

Public patient

Private patient

43

Median (%)

Orig. LPG

0 3.3 2.24 0.57 0 0

54.2

Price

Median Price Ratio

Orig. LPG

31.3 3.36 2.26 0.4 0.3

Affordability Number of Orig. Days wages days' of the lowest wages LPG paid govt worker for standard treatment with cotrimoxazole for a child respiratory infection 5.06 Duties and Taxes on Pharmaceuticals (Market) Core Questions There are duties on imported active pharmaceutical ingredients (APIs) There are duties on imported finished products VAT (value-added tax) or any other tax on pharmaceuticals Supplementary Questions Amount of duties on imported active pharmaceutical ingredients, APIs (%) Amount of duties on imported finished products (%) Amount of VAT on pharmaceutical products (%) Comments Yes Yes No

2006 2006 2006

Ministry of Finance Ministry of Finance Ministry of Finance

10 10 0

2006 2006 2006

Ministry of Finance Ministry of Finance Ministry of Finance

There are variations on the amount of duties charged, depending on the item/ingredient

44

Pakistan. Pharmaceutical Country Profile

Section 6 Pharm.procurement and distribution

6.01 Public Sector Procurement Core Questions Public sector procurement is Decentralized Centralized and decentralized If public sector procurement is wholly or partially centralized, it is under the responsibility of a procurement agency which is: Part of MoH Semi-Autonomous Autonomous A government procurement Agency which procures all public goods Public sector tenders bids documents are publicly available Public sector awards are publicly available Procurements are based on prequalification of suppliers If yes, please describe how it works Comments Supplementary Questions Is there a written public sector procurement policy?. If yes, please write the year of approval in the "year" field. Are there provisions giving priority in public procurement to goods produced by local manufacturers? The key functions of the procurement unit and those of the tender committee are clearly separated A process exists to ensure the quality of products procured If yes, the quality assurance process includes pre-qualification of products and suppliers If yes, explicit criteria and procedures exist for pre-qualification of suppliers If yes, a list of pre-qualified suppliers and products is publicly available Yes 2004 Public Procurement Regulatory Authority Yes No No No Yes Yes Yes 2009 2009 2009 MoH MoH MoH Yes No 2009 MoH 2009 MoH

Medical Store Depots in provinces call quotations from list of prequalified companies Previously the Medical Store Depot was functional, now it is partially functional due to decentralization

Unknown

Yes

2004

MoH

Yes Yes

2004

MoH

Yes Unknown

45

List of samples tested during the procurement process and results of quality testing is available Which of the following tender methods are used in public sector procurement: National competitive tenders International competitive tenders Direct purchasing 6.02 Public Sector Distribution Core Indicators The government supply system department has a Central Medical Store at National Level There are national guidelines on Good Distribution Practices (GDP) There is a licensing authority that issues GDP licenses If a licensing authority exists, does it accredit public distribution facilities? List of GDP certified warehouses in the public sector exists List of GDP certified distributors in the public sector exists Comments

Yes

2009

MoH

Yes No No

No

2009

MoH

Yes Yes Yes

2009 2009 2009

MoH MoH MoH

No No

MoH MoH

There are stores at district level, but no National Medical Store

46

Pakistan. Pharmaceutical Country Profile

Section 7 Selection and rational use

7.01 National Structures Core Questions National Standard Treatment Guidelines (STGs) for most common illnesses are produced/endorsed by the MoH. If yes, please insert year of last update of STGs in the "year" field. If yes, STG's are applied to Primary care. Please use the "year" field to write the year of last update of primary care STGs. If yes, STG's are applied to Secondary (hospitals). Please use the "year" field to write the year of last update of secondary care STGs. If yes, STG's are applied to Paediatric conditions. Please use the "year" field to write the year of last update of paediatric condition STGs. National essential medicines list (EML) exists. If yes, please write year of last update of EML in the "year" field. If yes, number of medicines on the EML If yes, there is a written process for selecting medicines on the EML If yes, the EML is publicly available A public or independently funded national medicines information centre provides information on medicines to prescribers, dispensers and consumers Public education campaigns on rational medicine use topics have been conducted in the previous two years A survey on rational use of medicines has been conducted in the previous two years A national programme or committee (involving government, civil society, and professional bodies) exists to monitor and promote rational use of Yes 2006 MoH

Unknown

Unknown

Unknown

Yes

2009

MoH

345 Unkown Unknown No

No

No

No

47

medicines A written National Strategy exists to contain antimicrobial resistance. If yes, please write year of last update of the strategy in the "year" field and attach document or provide URL below. Supplementary Questions The EML includes formulations specific for children There are explicit documented criteria for selection of medicines in the EML There is a formal committee or other equivalent structure for the selection of products on the national EML If yes, provide the official documentation establishing the committee * If yes, conflict of interest declarations are required from members of national EML committee National medicines formulary exists Is there a funded national intersectoral task force to coordinate the promotion of appropriate use of antimicrobials and prevention of spread of infection? A national reference laboratory/or any other institution has responsibility for coordinating epidemiological surveillance of antimicrobial resistance 7.02 Prescribing Core Questions Legal provisions exist to govern the licensing and prescribing practices of prescribers. Legal provisions exist to restrict dispensing by prescribers. Regulations require hospitals to organize/develop Drug and Therapeutics Committees (DTCs) Mandatory continuing education that includes pharmaceutical issues is required for Doctors Mandatory continuing education that includes pharmaceutical issues is required for Nurses Mandatory continuing education that No No

Yes Unknown

2009

MoH

Unknown

No No

2009 2009

MoH MoH

No

2009

MoH

Yes

2010

Pakistan Medical & Dental Council

No No

No

No

No

48

Pakistan. Pharmaceutical Country Profile

includes pharmaceutical issues is required for Paramedical staff Prescribing by INN name is obligatory in: Private sector Public sector Average number of medicines prescribed per patient contact in public health facilities (mean) Supplementary Questions A professional association code of conduct exists governing professional behaviour of doctors A professional association code of conduct exists governing professional behaviour of nurses Diarrhoea in children treated with ORS (%) 7.03 Dispensing Core Questions Legal provisions exist to govern dispensing practices of pharmaceutical personnel The basic pharmacist training curriculum includes components on: Concept of EML Use fo STGs Drug Information Clinical pharmacology Medicines supply management Mandatory continuing education tat includes rational use of medicines is required for pharmacists Substitution of generic equivalents at the point of dispensing in public sector facilities is allowed Substitution of generic equivalents at the point of dispensing in private sector facilities is allowed Antibiotics are sold over-the-counter without a prescription Injectable medicines are sold overthe-counter without a prescription Supplementary Questions A professional association code of conduct exists governing Yes Yes Yes Yes Yes Yes No No No 2.85 2003 Rational Use Survey

Unknown

Unknown

16.1

2007

Demographich Health Survey of Pakistan

Yes

Yes

No

Yes

2005

International Journal for Quality in Health Care International Journal for Quality in Health Care

Yes

2005

49

professional behaviour of pharmacists Are the following categories of staff prescribing prescription-only medicines at primary care level in the public sector? Doctors Nurses Pharmacists Yes No No

50

Pakistan. Pharmaceutical Country Profile

Section 8 Household data/access

8.01 Data from Household Surveys Core Questions Adults with an acute condition in twoweek recall period who took all medicines prescribed by an authorized prescriber (%) Adults with acute conditions not taking all medicines because they cannot afford them (%) Adults (from poor households) with an acute health condition in twoweek recall period who took all medicines prescribed by an authorized prescriber (%) Adults (from poor households) with an acute condition in two-week recall period who did not take all medicines because they cannot afford them (%) Adults with chronic conditions taking all medicines prescribed by an authorized prescriber (%) Adults (from poor households) with chronic conditions not taking all medicines because they cannot afford them (%) Adults (from poor households) with chronic conditions who usually take all medicines prescribed by an authorized prescriber (%) Children (from poor households) with an acute condition in two-week recall period who took all medicines prescribed by an authorized prescriber (%) Supplementary Questions Adults with acute conditions not taking all medicines because the medicines were not available (%) Adults with chronic conditions not taking all medicines because they cannot afford them (%) Adults with chronic conditions not taking all medicines because the medicines were not available (%) Children with acute conditions taking all medicines prescribed by an 91.2 2003 World Health Survey

68.0

2003

World Health Survey

89.4

2003

World Health Survey

66.9

2003

World Health Survey

83.8

2003

World Health Survey

37.5

2003

World Health Survey

70.5

2003

World Health Survey

85.5

2003

World Health Survey

25.6

2003

World Health Survey

47.5

2003

World Health Survey

17.1

2003

World Health Survey

90.0

2003

World Health Survey

51

authorized prescriber (%) Children with acute conditions not taking all medicines because they cannot afford them (%) Children with acute conditions not taking all medicines because the medicines were not available (%) Children (from poor households) with acute conditions not taking all medicines because they cannot afford them (%) 60.4 2003 World Health Survey

23.8

2003

World Health Survey

71.9

2003

World Health Survey

52