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MeTA Baseline Pharmaceutical sector scan - Cross-country analysis
Pharma sector scan Form MeTA Key Issue CORE Pharma sector scan "High Priority" Indicator GHANA JORDAN KYRGYZSTAN PERU PHILIPPINES UGANDA ZAMBIA Type of indicator
Form 1 (Country profile: demographic and socioeconomic indicators) SECONDARY Ind. 1.1: Population, total 23,351,000 5,980,000 5,300,000 28,220,764 88,574,000 30,700,000 12,620,000 number
Form 5 (Medicines policy and regulatory framework) Transparency & accountability SECONDARY Ind. 5.2: National Medicines Policy official document exists (+ year of update) Yes (2004) Yes (2002) Yes (2007) Yes (2004) Yes (ongoing) Yes (2002) Yes (2005) Y/N
Form 5 (Medicines policy and regulatory framework) Transparency & accountability CORE Ind. 5.4: Legal provisions exist establishing the powers and responsibility of a medicines regulatory agency Yes Yes Yes Yes Yes Yes Yes Y/N
Form 5 (Medicines policy and regulatory framework) Transparency & accountability SECONDARY Ind. 5.8: Legal provisions exist requiring transparency and accountability and promoting a code of conduct in regulatory work Yes Yes Yes Yes Yes No Yes Y/N
Form 5 (Medicines policy and regulatory framework) Transparency & accountability SECONDARY Ind. 5.9: Formal code of conduct exists that applies to public officials and staff involved in pharmaceutical-related activities Yes Yes Yes Yes Yes Yes Yes Y/N
Form 6 (Medicines market at retail price) Quality CORE Ind. 6.4: Market share of generics by value (%) n.a. n.a. 59% 5% 40% not answered n.a. percentage
Form 6 (Medicines market at retail price) Quality SECONDARY Ind. 6.6: List of top 20 medicines by value is publicly available No No No Restricted access Yes No not answered Y/N
Form 7 (Medicines financing: Government expenditure and health insurance) Availability SECONDARY Ind. 7.5: Percent government medicines expenditures (% of total medicines expenditures) 10% 33% 44% 34% 12% n.a. 8% percentage
Form 7 (Medicines financing: Government expenditure and health insurance) Availability CORE Ind. 7.10: Proportion of the population covered by the NHI or SHI (% of the population) 61% 86% 78% 54% 80% not applicable not applicable percentage
Form 7 (Medicines financing: Government expenditure and health insurance) Availability SECONDARY Ind. 7.11: List of medicines reimbursed by NHI or SHI and structure of reimbursement is available Yes Yes Yes No Yes not applicable not applicable Y/N
Form 8 (Medicines financing: Public program providing free medicines) Availability CORE Ind. 8.1: There is an official government programme for obtaining free medicines Yes Yes Yes Yes Yes Yes Yes Y/N
Form 9 (Medicines financing: Patient fees and copayments) Availability CORE Ind. 9.4: Medicines are free in public primary care facilities Yes No Yes No Yes Yes Yes Y/N
Form 9 (Medicines financing: Patient fees and copayments) Availability SECONDARY Ind. 9.5: If not, medicines copayments are used to pay salaries of public primary care workers not applicable No not applicable No not applicable not applicable not applicable Y/N
Form 11 (Medicines trade: Registration) Quality CORE Ind. 11.1: An explicit and transparent process exists for assessing applications for registration of pharmaceutical products Yes Yes Yes Yes Yes Yes Yes Y/N
Form 11 (Medicines trade: Registration) Quality CORE Ind. 11.10: List of registered products is publicly available, identifying originator brands, branded generics and generics Yes Restricted access Yes No Upon request Yes Yes Y/N
Form 11 (Medicines trade: Registration) Quality SECONDARY Ind. 11.11: List and application status of products submitted for registration are publicly available No Yes Restricted access Restricted access Upon request No No Y/N
Form 12 (Medicines trade: Manufacturing) Quality CORE Ind. 12.1: List of GMP compliant manufacturing plants with date and results of latest inspection available Restricted access Restricted access Yes Yes Yes Upon request Upon request Y/N
Form 13 (Medicines trade: Quality Assurance) Quality SECONDARY Ind. 13.1: Legal provisions exist to inspect premises and collect samples Yes Yes Yes Yes Yes Yes Yes Y/N
Form 13 (Medicines trade: Quality Assurance) Quality CORE Ind. 13.7: List is publicly available giving detailed results of quality testing of past year Restricted access Yes No Yes Upon request No No Y/N
Form 13 (Medicines trade: Quality Assurance) Quality CORE Ind. 14.1.a: Legal or regulatory provisions exist for setting manufacturer selling price No Yes No No Yes No No Y/N
Form 14 (Medicines trade: Price control and transparency) Prices CORE Ind. 14.4: Regulations exist mandating that retail medicine price information should be publicly accessible No Yes Yes Yes Yes No No Y/N
Form 17 (Medicines trade: Promotion and advertising - Legal and Regulatory provisions) Promotion CORE Ind. 17.1: Legal provisions exist to control promotion and/or advertising of prescription medicines Yes Yes Yes Yes No Yes Yes Y/N
Form 17 (Medicines trade: Promotion and advertising - Legal and Regulatory provisions) Promotion SECONDARY Ind. 17.4: Regulatory pre-approval is required for medicines advertisements and/or promotional materials Yes Yes Yes No Yes Yes Yes Y/N
Form 17 (Medicines trade: Promotion and advertising - Legal and Regulatory provisions) Promotion SECONDARY Ind. 17.6: SOP exist governing the behaviour of public procurement agencies in their interactions with sales representatives/wholesalers Yes Restricted access Yes No Yes No No Y/N
Form 18 (Medicines trade: Promotion and advertising - Code of Conduct and Spending) Promotion CORE Ind. 18.3: Pharma. companies are required to report promotion and advertising budget in taxes disclosures No No Yes No Yes Yes No Y/N
Form 19 (Medicines supply system: Selection) Transparency & accountability CORE Ind. 19.2: National Essential Medicines List exists Yes (2004) Yes (2009) Yes (2009) Yes (2010) Yes (2008) Yes (2007) Yes (2008) Y/N
Form 19 (Medicines supply system: Selection) Transparency & accountability CORE Ind. 19.3: Explicit criteria for selecting medicines on national EML Yes Yes Yes Yes Yes (2008) Yes (2007) Yes Y/N
Form 20 (Medicines supply system: Procurement in the public sector) Transparency & accountability CORE Ind. 20.1: There is a tender board/committee overseeing public procurement that is independent from the procurement office Yes Yes Yes Yes Yes Yes Yes Y/N
Form 20 (Medicines supply system: Procurement in the public sector) Transparency & accountability SECONDARY Ind. 20.3: A functioning system exists to prequalify suppliers for public procurement Yes Yes No Yes No Yes Yes Y/N
Form 20 (Medicines supply system: Procurement in the public sector) Transparency & accountability CORE Ind. 20.5: Public sector tenders are publicly available Yes Yes Yes Yes Yes Yes Yes Y/N
Form 20 (Medicines supply system: Procurement in the public sector) Transparency & accountability CORE Ind. 20.6: Winning bids in the public sector are publicly available Yes Yes Yes Yes Yes Yes not answered Y/N
Form 20 (Medicines supply system: Procurement in the public sector) Transparency & accountability CORE Ind. 20.7: Public sector tenders use a transparent electronic bidding process No Yes No Yes No No No Y/N
Form 22 (Medicines supply system: Distribution) Quality CORE Ind. 22.1: National guidelines for GDP exist No Restricted access No No Yes No Yes Y/N
Form 22 (Medicines supply system: Distribution) Quality CORE Ind. 22.2: List of GDP compliant distributors is available No No No No Yes No No Y/N
Form 22 (Medicines supply system: Distribution) Quality SECONDARY Ind. 22.9: Legal provisions exist for licensing wholesalers Yes Yes Yes Yes Yes Yes Yes Y/N
Form 22 (Medicines supply system: Distribution) Quality SECONDARY Ind. 22.10: List of wholesalers is publicly available Upon request Yes Yes No Upon request Yes Yes Y/N
Form 23 (Medicines access) Availability SECONDARY Ind. 23.6: % of households obtaining free medicines at public health care facilities 39% 32% not answered 54% n.a. 47% n.a. percentage
Form 23 (Medicines access) Availability CORE Ind. 23.7: Availability of basket of key medicines in health care facilities 80% 63% 68% 80% 66% 48% 70-90% percentage
Form 24 (Medicines used: National structures) Transparency & accountability CORE Ind. 24.1: A national programme/committee exists to monitor and promote rational drug use No Yes Yes Yes Yes Yes Yes Y/N
Form 24 (Medicines used: National structures) Transparency & accountability SECONDARY Ind. 24.6: % of facilities with copy of national STG 75% 28% 100% n.a. 35% 81% 40% percentage
Form 25 (Medicines use: Prescribing) Transparency & accountability CORE Ind. 25.1: Legal provisions exist to govern the licensing and prescribing practice of prescribers and health facilities Yes Yes Yes Yes Yes Yes Yes Y/N
Form 25 (Medicines use: Prescribing) Transparency & accountability SECONDARY Ind. 25.6: Average number of medicines per prescription 4 public: 3 2 health posts: 2 2 3 3 value
Form 25 (Medicines use: Prescribing) Transparency & accountability SECONDARY Ind. 25.7: Percentage of medicines prescribed by INN name 60% 8% not answered health posts: 99% 84% 72% 70% percentage
Form 26 (Medicines use: Dispensing) Transparency & accountability CORE Ind. 26.1: Legal provisions exist to govern the licensing and dispensing practice of pharmacists and pharmacy establishments Yes Yes Yes Yes Yes Yes Yes Y/N
Form 26 (Medicines use: Dispensing) Transparency & accountability SECONDARY Ind. 26.2: Legal provisions exist to restrict prescribing by dispensers Yes Yes Yes Yes Yes Yes Yes Y/N
30 November 2010 www.medicinestransparency.org 1
MeTA Baseline Pharmaceutical sector scan - Cross-country analysis
Worksheet "Selected list" - Explanatory notes regarding the table structure
The data collected by the MeTA pilot countries for component 1 (1A - Pharmaceutical sector scan) are divided in eight domains [COLUMN A], with several data forms
to be completed for each of them:
1. Country Profile (forms 1-2-3-4)
2. Medicines Policy and Regulatory Framework (form 5)
3. Medicines Market (form 6)
4. Medicines Financing (forms 7-8-9)
5. Medicines Trade (forms 10-11-12-13-14-15-16-17-18)
6. Medicines Supply System (forms 19-20-21-22)
7. Medicines Access (form 23)
8. Medicines Use (forms 24-25-26-27)
The above domains are linked to the key issues [COLUMN B], as appearing on the MeTA website:
• Prices
• Quality
• Availability
• Promotion
• Transparency & accountability
• Multistakeholder working
[COLUMN C] distinguishes between core and secondary indicators.
The worksheet presents a list of 45 "high priority" indicators [COLUMN D]. The selection of the indicators in this table started with the premise that only those
indicators which are marked as high priority for MeTA (using the mark in the data collection forms) should be entered in the comparative country data set.
The data are extracted from the individual country "Report on the Pharmaceutical sector Scan", prepared by Ghana, Jordan, Kyrgyzstan, Peru, the Philippines,
Uganda and Zambia [COLUMNS E-K].
[COLUMN L] indicates the type of indicator .
A filter has been added to the following column headers in order to select the indicators.
The print range has been selected so that the most relevant selection of the worksheet can be printed on one page: including the name of the indicator and the
results for the seven pilot countries.
Apart from the data extracted from the seven country reports, a traffic light analysis was added to the cross-country table, by using - where applicable - green, red
and orange colours which refer to the information being:
· available and disclosed
· available but not disclosed
· not available at all
The traffic light colours applied to the indicators reflect the data as reported in the pharmaceutical sector scan reports, with relevant comments regarding the
indicators or countries included in the explanatory notes below.
Component 1 of the MeTA baseline provides an inventory of existing pharmaceutical sector data that is then made publicly available. The Pharmaceutical Sector
Scan (component 1a) captures yes/no or quantitative responses to implicit questions and asks for sources, while the Data Disclosure Survey (component 1b),
captures more descriptive and qualitative information on the policies, practices and achievements of countries. This may account for slight discrepancies in their
respective country comparison tables in terms of what countries may have provided as ‘disclosed’ information. In addition, the Data Disclosure Survey was conducted
at the end of 2009, while the Pharmaceutical Sector Scan was mostly conducted by countries in the first half of 2010.
n.a.: data not available
Where relevant hyperlinks (see underlined words) were added to the table information. The URLs for the hyperlinks were extracted from the individual country reports,
or added by the MeTA International Secretariat when not explicitly stated in the reports.
For more details we refer to the individual country reports which can be downloaded from the MeTA website.
30 November 2010 www.medicinestransparency.org 2
MeTA Baseline Pharmaceutical sector scan - Cross-country analysis
Worksheet "Selected list" - Explanatory notes regarding the indicators
Ind. 5.8: Legal provisions exist requiring transparency and accountability and promoting a code of conduct in regulatory work
• Jordan refers to two documents in Arabic: legislation: http://www.jfda.jo/Download/Laws/24_82.pdf (this one is used for the hyperlink);
http://www.pm.gov.jo/arabic/uploads/MODAWANA-QAWA3D.pdf (but the latter cannot be downloaded and is replaced by the following URL:
http://www.memr.gov.jo/Portals/0/MODAWANA-QAWA3D.pdf).
Ind. 6.4: Market share of generics by value (%)
• Ghana: info not available although most medicines are generic. Reference is made to "Andreas Seiter & Martha Gyansa-Lutterodt (2009), Policy Note: The
Pharmaceutical Sector in Ghana, November 2009. See: http://apps.who.int/medicinedocs/documents/s16765e/s16765e.pdf;
• Peru: the market share of generics is 485% in the data collection forms but this is corrected in the supporting sources document to 4.85%;
• Philippines: According to Mr. Reiner Gloor (interview), it is estimated at around 40% but the data would best be obtained March 2010 as the market is still unstable
after the imposition of the maximum retail price;
• Zambia: Data not available because WHO/HAI 2010 Survey report not yet completed at time of completion of the pharmaceutical sector scan.
Ind. 6.6: List of top 20 medicines by value is publicly available
• Ghana: No list available; reference is made to Andreas Seiter & Martha Gyansa-Lutterodt (2009) Policy Note: The Pharmaceutical Sector in Ghana, November
2009; See http://apps.who.int/medicinedocs/documents/s16765e/s16765e.pdf;
• Peru: although the data collection form states that Peru has a top 20 medicines list publicly available, the list is only available to DIGEMID because they have a
subscription to IMS Health, hence "restricted access" and "orange".
• Philippines: Reference is made to the Top 20 pharmaceutical brands as of 2007 in the Philippine Pharmaceutical Industry Factbook 7th Edition
(http://www.phap.org.ph/images/page/main.factbook/factbook_11_2008.pdf) but the link does not work - added the following webpage:
http://www.phap.org.ph/files/ethics/factbook.pdf;
• Zambia: Data not available because WHO/HAI 2010 Survey report not yet completed at time of completion of the pharma sector scan, and therefore no answer was
given.
Ind. 7.5: Percent government medicines expenditures (% of total medicines expenditures)
• Percentage. Data are based on three different years: 2008 (Ghana, Kyrgyzstan and the Philippines), 2009 (Jordan, Uganda and Zambia) and 2010 (Peru), so that
cross-country findings may be biased.
• Ghana: The public sector operates a revolving drug fund so that the government budget and expenditure for medicines tend to be the same (see indicator 7.2);
• Jordan: 333% in data collection document while 27,08% in the references document; I have changed the 333% to 33.3% because the multi-stakeholder country
report states that "Pharmaceutical expenditure in Jordan is high, accounting for about 34% of total health expenditure and about 3.1% of GDP in 2007" (page 15).
• Peru: the percent government medicines expenditures is 3387% in the data collection forms but this is corrected in the supporting sources document to 33.87%;
• Philippines: 12% when using the MOH budget for medicines of 12-15 Billion [DOH + PhilHealth] as reference - see indicator 7.1.
Ind. 7.10: Proportion of the population covered by the NHI or SHI (% of the population)
• In the country reports of Ghana and the Philippines (which were the pilot testing countries) this indicator is listed as indicator 7.11;
• Jordan: The rate is 83 % but with 8% duplication (Health insurance administration – MOH has unreported figure - 86%: this figure is used in the data collection
tables). The High Health Council with DOS will conduct a household survey on November 2010. This survey will provide updated figure on percent of population
covered distributed by insurers parties;
• Peru: the proportion of the population covered by NHI or SHI is 543% in the data collection forms but this is corrected in the supporting sources document to 54.3%;
• Uganda: There is no social or national health insurance, but bill is in process. Therefore changed wording to "not applicable";
• Zambia: There is no social or national health insurance and therefore changed wording to "not applicable".
Ind. 7.11: List of medicines reimbursed by NHI or SHI and structure of reimbursement is available
• In the country reports of Ghana and the Philippines (which were the pilot testing countries) this indicator is listed as indicator 7.12;
• Kyrgyzstan: only reference to MHIF Additional Drug Package list, no link to a website;
• Philippines: The PhilHealth Drug Price Reference Index (DPRI) lists recommended drug prices to inform consumers about the medicines prices (see
http://www.doh.gov.ph/files/pharma50_final_dpri.pdf) but this is not a list of medicines reimbursed by NHI or SHI. The circulars on
http://www.philhealth.gov.ph/circulars/index.htm include guidelines for reimbursement of different health services, but this is not a list of reimbursed medicines either,
and therefore coloured "orange";
• Uganda: There is no social or national health insurance, but bill is in process. Therefore changed wording to "not applicable";
• Zambia: There is no social or national health insurance and therefore changed wording to "not applicable".
Ind. 9.5: If not, medicines copayments are used to pay salaries of public primary care workers
In fact this indicator becomes irrelevant for the five countries that responded "yes" to indicator 9.4; therefore added "not applicable".
Ind. 11.1: An explicit and transparent process exists for assessing applications for registration of pharmaceutical products
• Kyrgyzstan: no reference to URL, no comment in supporting sources document; only reference to Drug Law 30 April 2003 & MOH order 8 Sept 1998.
Ind. 11.10: List of registered products is publicly available, identifying originator brands, branded generics and generics
• For products with valid FDB registration numbers, Ghana does not explicitly list the originator brands, branded generics and generics separately, but active
ingredient and dosage form, and discloses the names of the applicant, the manufacturer and the local agent on the internet (hyperlink added);
• Jordan: The document is available but only internally disclosed, and therefore "No" to "restricted access" and hence the "orange" colour;
• Peru: "yes" in the data collection forms, but comment in the supporting sources document that info does not exist (actual norms do no say that info has to be
presented as asked in the question);
• Philippines: The list is not publicly available but may be obtained upon presentation of a written request and reason/s for requesting the same;
• Uganda: Medicines register publicly available, see the "List of registered human drugs (Last updated on 2010-11-01)" from http://www.nda.or.ug/;
• The Products Register 2010 document from Zambia can be downloaded from the internet: it contains the name of the product and generic name.
Ind. 11.11: List and application status of products submitted for registration are publicly available
• Jordan: Submitted Drugs for Registration list available on the internet;
• Kyrgyzstan: Information on products submitted for registration and at what stage of the review is available to legal and physical persons in case of receiving a
written request. This information is not posted on the website. Therefore changed the status to "orange".;
• Peru: Reference is made to http://www.digemid.minsa.gob.pe/aplicaciones/consulta_expediente/listado.asp: it is only possible to consult the status of a registration
application when one has the applicant's number. It is not possible to obtain a list of all applications, hence: "orange";
• Philippines: List of new pharmaceutical product applications are available per month (for the last six-seven months):
http://www.bfad.gov.ph/default.cfm?page_id=1192&parent=0. Application status (approved or rejected) is not available publicly, but one may call the BFAD to know
the status of the listed products since the details of product name, registration number, and name of manufacturer/distributor are listed, hence status changed to
"orange".
30 November 2010 www.medicinestransparency.org 3
MeTA Baseline Pharmaceutical sector scan - Cross-country analysis
Worksheet "Selected list" - Explanatory notes regarding the indicators
Ind. 12.1: List of GMP compliant manufacturing plants with date and results of latest inspection available
• Ghana has not appended the list to the country report: the list exists but is not publicly available, only to the regulator and the clients, and therefore "orange" and
"restricted access";
• Jordan: Hard copy available from Inspection department (internal document), and therefore changed the status from "Yes" to "Restricted access" and the colour to
"orange";
• Kyrgyzstan: The data collection report says "Yes" while the supporting sources document says "There are no pharmaceutical manufacturers satisfying GMP
standards in the Kyrgyz Republic"; there is no reference to a website but in the Kyrgyz attachments there is a document called "INTSites_inspected by NDRA" and the
subtitle says "Certification body DLO and MT carried out the inspection the following manufacturing sites" (translated by Google Translator), so "Yes" with comment in
the explanatory notes.
• Peru: Annual lists of GMP compliant manufacturing plants (online up to 2005: http://www.digemid.minsa.gob.pe/decvs/dcvs/index.htm): the date and results of latest
inspection are not indicated but the validity period is given;
• Philippines: BFAD List of Establishments with Certificate Of Good Manufacturing Practice, http://www.bfad.gov.ph/default.cfm?page_id=1302&parent=0. Table with
list of 27 October 2010 exported to Excel file;
• Lists from Uganda and Zambia can be obtained upon request (and therefore "orange").
Ind. 13.7: List is publicly available giving detailed results of quality testing of past year
• Ghana: Registration testing reports are confidential and only available to applicants. Post market surveillance reports are however available and in the public
domain at the FDB website as press releases: see http://www.fdbghana.gov.gh/. This could be coloured "orange" because the info is available but not disclosed
("restricted access");
• Jordan: it is confirmed that the list exists but no reference is made to the list;
• Peru: Annual lists with results of quality testing available on http://www.digemid.minsa.gob.pe/decvs/uni_evaluacion/observatorios.htm. Detailed results of the quality
testing are limited to the "result/outcome": conform (green) or not (red), with some in-between categories (yellow and orange);
• Philippines: The list is not publicly available but can be requested from the BFAD;
• Uganda: List is available on written request to the Executive Secretary, NDA (National Drug Quality Control Laboratory) and approval is required. Uganda has
answered "No" to this question, but changed to "restricted access" and "orange" on basis of their explanation.
Ind. 17.6: SOP exist governing the behaviour of public procurement agencies in their interactions with sales representatives/wholesalers
• Jordan: Standard operating procedure is an internal document, and therefore changed the status from "Yes" to "restricted access" (and orange): see
http://www.jpd.gov.jo/ReadPaner.php?id=135&sub_id=7;
• Philippines: The procedures for public procurement are listed. The processes are made transparent. Disclosure of relations and conflict of interest statements are
also required from the bidders. The Procurement Service has a policy of no contact and no gift-receiving from bidders during the bidding process (see Republic Act
9184, 2002, Article XX Section: http://www.pagc.gov.ph/File/Laws%20over%20which%20PAGC%20has%20jurisdiction%20to%20investigate/RA_9184.pdf).
Ind. 19.2: National Essential Medicines List exists
• Jordan: The URL http://www.jfda.jo/RDU/JNDFBook/Annex/Annex.htm refers to 2006 Jordan Rational Drug List, while the latest version should date from 2009
according to the data collection report; WHO URL also refers to 2006 list: http://apps.who.int/medicinedocs/documents/s17240e/s17240e.pdf.
• Peru: in the supporting sources document there was no link to the MOH's website with the EML, but have added it:
http://www.digemid.minsa.gob.pe/daum/urm/RM062-2010-MINSA.pdf;
• Uganda: Essential Medicines List 2007 downloaded from WHO website: http://www.who.int/selection_medicines/country_lists/uga_eml_2007.pdf;
• Zambia: No URL for the Zambian EML, only electronic version of Zambia 2008 list available. Hard copies of the 2009 revised EML have been distributed and will be
published on MOH and PRA websites soon.
Ind. 22.1: National guidelines for GDP exist
• Jordan: (see comments in Arabic in data collection forms): guidelines exist but are not disclosed to the public, thus "restricted access" and hence "orange".
Ind. 22.2: List of GDP compliant distributors is available
• Philippines: Data obtained via e-mail from BFAD, but list not attached to the document.
Ind. 23.7: Availability of basket of key medicines in health care facilities
• Philippines: 60% in public pharmacies and 96.7% in private pharmacies (Batangan 2009) or ~66% (So 2009), the latter has been included in the comparative table;
• Zambia: Indication given, but waiting for updated data because WHO/HAI 2010 Survey report not yet completed at time of completion of the pharma sector scan.
The data have been collected but are not yet publicly available.
Ind. 25.6: Average number of medicines per prescription
• Jordan: Public sector: 2.97, private sector: 2.62.
• Peru: 2.00 in health posts, 1.7 in health centres and 1.9 in hospitals.
• Philippines: Preliminary data of a WHO Level II Survey sent to the investigators via e-mail from Dr. Dennis Batangan, December 2009. Gloor (2009) gives a number
of 3-4.
Ind. 25.7: Percentage of medicines prescribed by INN name
• Peru: 99.33% in health posts, 98.8% in health centres and 89% in hospitals.
30 November 2010 www.medicinestransparency.org 4
MeTA Baseline Pharmaceutical sector scan - Cross-country analysis
Worksheet "Selected list" - Key findings
Ind. 5.2: National Medicines Policy official document exists (+ year of update)
All seven countries have a National Medicines Policy, with the "oldest" official document dating from 2002 (Jordan) and the most recent one from 2007 (Kyrgyzstan). The medicine policies
of the Philippines and Zambia are currently undergoing review.
Ind. 5.4: Legal provisions exist establishing the powers and responsibility of a medicines regulatory agency
All seven pilot countries have legal provisions which establish the powers and responsibility of a medicines regulatory agency.
Ind. 5.8: Legal provisions exist requiring transparency and accountability and promoting a code of conduct in regulatory work
Except for Uganda, all pilot countries have legal provisions which require transparency and accountability and which promote a code of conduct in their regulatory work.
Ind. 5.9: Formal code of conduct exists that applies to public officials and staff involved in pharmaceutical-related activities
All seven pilot countries have a formal code of conduct that applies to public officials and staff involved in pharma-related activities.
Ind. 6.4: Market share of generics by value (%)
Only three countries have reported on this indicator: Kyrgyzstan (~60%), Peru (~5%) and the Philippines (40%), with quite divergent results.
Ind. 6.6: List of top 20 medicines by value is publicly available
The list of top 20 medicines is only publicly available in the Philippines.
Ind. 7.5: Percent government medicines expenditures (% of total medicines expenditures)
The percentage of government medicines expenditures compared to total medicines expenditures in the country range from 8.30% (Zambia) to 44.30% (Kyrgyzstan), with Ghana and the
Philippines clustered around the Zambian percentage, and Jordan and Peru around the Kyrgyz result.
Ind. 7.10: Proportion of the population covered by the NHI or SHI (% of the population)
In those countries where the population is covered by the national or social health insurance (all except for Uganda and Zambia) the percentage ranges from 54.30% (Peru) to 86%
(Jordan).
Ind. 7.11: List of medicines reimbursed by NHI or SHI and structure of reimbursement is available
In four (Ghana, Jordan, Kyrgyzstan and the Philippines) of the five countries where medicines are reimbursed by NHI or SHI the list and the structure of the reimbursement is available.
Ind. 8.1: There is an official government programme for obtaining free medicines
The seven pilot countries have an official government programme for obtaining free medicines.
Ind. 9.4: Medicines are free in public primary care facilities
Medicines are free in five of the seven pilot countries (not free in Jordan and Peru).
Ind. 9.5: If not, medicines copayments are used to pay salaries of public primary care workers
In Jordan and Peru where medicines are not available for free in the primary care facilities (see indicator 9.4), medicines copayments are not used to pay salaries of public primary care
workers.
Ind. 11.1: An explicit and transparent process exists for assessing applications for registration of pharmaceutical products
All seven pilot countries have indicated that they have an explicit and transparent process for assessing applications for registration of pharmaceutical products.
Ind. 11.10: List of registered products is publicly available, identifying originator brands, branded generics and generics
Except for Peru all pilot countries have publicly available lists of registered products. In Jordan and the Philippines access to the list is restricted.
Ind. 11.11: List and application status of products submitted for registration are publicly available
Four of the seven countries make this list publicly available (although restricted access in Kyrgyzstan, Peru and the Philippines); Ghana, Uganda and Zambia don't publish the list and
application status.
Ind. 12.1: List of GMP compliant manufacturing plants with date and results of latest inspection available
All seven pilot countries have a list of GMP compliant manufacturing plants, with restricted access in Ghana, Jordan, Uganda and Zambia.
Ind. 13.1: Legal provisions exist to inspect premises and collect samples
All seven countries have legal provisions to inspect premises and collect samples.
Ind. 13.7: List is publicly available giving detailed results of quality testing of past year
The list is available in four of the seven pilot countries (Ghana, Jordan, Peru and the Philippines respectively) with restricted access in the first and last country.
Ind. 14.1.a: Legal or regulatory provisions exist for setting manufacturer selling price
Legal or regulatory provisions for setting manufacturer selling price only exist in Jordan and the Philippines.
Ind. 14.4: Regulations exist mandating that retail medicine price information should be publicly accessible
Four of the seven countries have existing regulations which mandate that retail medicine price information is publicly accessible: Jordan, Kyrgyzstan, Peru and the Philippines.
Ind. 17.1: Legal provisions exist to control promotion and/or advertising of prescription medicines
All pilot countries except the Philippines have legal provisions to control promotion and/or advertising of prescription medicines.
Ind. 17.4: Regulatory pre-approval is required for medicines advertisements and/or promotional materials
Except for Peru all pilot countries require regulatory pre-approval for medicines advertisements and/or promotional materials.
Ind. 17.6: SOP exist governing the behaviour of public procurement agencies in their interactions with sales representatives/wholesalers
30 November 2010 www.medicinestransparency.org 5
MeTA Baseline Pharmaceutical sector scan - Cross-country analysis
Worksheet "Selected list" - Key findings
Four of the seven pilot countries have standard operating procedures that govern the behaviour of public procurement agencies in their interactions with sales representatives/wholesalers:
Ghana, Jordan (with restricted access), Kyrgyzstan and the Philippines.
Ind. 18.3: Pharmaceutical companies are required to report promotion and advertising budget in taxes disclosures
Only in three of the seven countries are pharmaceutical companies required to report promotion and advertising budget in taxes disclosures: in Kyrgyzstan, the Philippines and Uganda.
Ind. 19.2: National Essential Medicines List exists
All seven pilot countries have a national Essential Medicines List.
Ind. 19.3: Explicit criteria for selecting medicines on national EML
All seven countries explicitly included the criteria for selecting medicines in their EMLs.
Ind. 20.1: There is a tender board/committee overseeing public procurement that is independent from the procurement office
All seven countries have an independent tender board/committee overseeing public procurement.
Ind. 20.3: A functioning system exists to prequalify suppliers for public procurement
Five of the seven countries indicate that a functioning system exists to prequalify suppliers for public procurement. In Kyrgyzstan and the Philippines such a system does not exist.
Ind. 20.5: Public sector tenders are publicly available
Public sector tender are made publicly available in all seven pilot countries.
Ind. 20.6: Winning bids in the public sector are publicly available
All pilot countries make winning bids in the public sector publicly available (not known for Zambia).
Ind. 20.7: Public sector tenders use a transparent electronic bidding process
Only in Jordan and Peru public sector tenders use a transparent electronic bidding process.
Ind. 22.1: National guidelines for GDP exist
National guidelines for GDP exist only in Jordan, the Philippines and Zambia.
Ind. 22.9: Legal provisions exist for licensing wholesalers
Legal provisions for licensing wholesalers exist in all seven pilot countries.
Ind. 22.10: List of wholesalers is publicly available
Except for Peru the list of wholesalers is publicly available (though only upon request in Ghana and the Philippines).
Ind. 23.6: % of households obtaining free medicines at public health care facilities
The percentage of households obtaining free medicines at public health facilities ranges from 32% (in Jordan) to 54.40% (in Peru). The percentages for Ghana (39%) and Uganda (47%) lie
in between.
Ind. 23.7: Availability of basket of key medicines in health care facilities
Three categories/ranges of availability of a basket of key medicines in health care facilities can be distinguished: (1) less than 50% (Uganda); (2) between 50 and 70% (Jordan, Kyrgyzstan
and the Philippines) and (3) more than 70% (Ghana, Peru and Zambia).
Ind. 24.1: A national programme/committee exists to monitor and promote rational drug use
Except for Ghana, a national programme or committee exists to monitor and promote rational drug use.
Ind. 24.6: % of facilities with copy of national STG
The picture with regards to the percentage of facilities with a copy of the national STG is diffuse: it ranges from 27.80% in Jordan to 100% in Kyrgyzstan, with all other countries (except for
Peru where no data were available) reporting percentages in between.
Ind. 25.1: Legal provisions exist to govern the licensing and prescribing practice of prescribers and health facilities
All seven pilot countries have legal provisions that govern the licensing and prescribing practice of prescribers and health facilities.
Ind. 25.6: Average number of medicines per prescription
Ghana has the highest average number of medicines per prescription (4) of all pilot countries. Jordan, Uganda and Zambia have an average number of 3, while Kyrgyzstan, Peru and the
Philippines report an average of 2.
Ind. 25.7: Percentage of medicines prescribed by INN name
The Philippines have the highest percentage (84%) of the six countries (Kyrgyzstan not) that have indicated the percentages of medicines prescribed by INN name.
Ind. 26.1: Legal provisions exist to govern the licensing and dispensing practice of pharmacists and pharmacy establishments
All seven pilot countries have legal provisions that govern the licensing and dispensing practices of pharmacists and pharmacy establishments.
Ind. 26.2: Legal provisions exist to restrict prescribing by dispensers
All seven countries have legal provisions to restrict prescribing by dispensers.
30 November 2010 www.medicinestransparency.org 6
MeTA Baseline Pharmaceutical sector scan - Cross-country analysis
Ind. 16.1-16.14: Consumer Prices of Medicines on HAI Global Core List
Median price ratios are presented here.
PUBLIC SECTOR PRIVATE SECTOR
Originator medicines Ghana Jordan Kyrgyzstan Peru Philippines Uganda Originator medicines Ghana Jordan Kyrgyzstan Peru Philippines Uganda
Amitryptyline 25mg Cap/tab Amitryptyline 25mg Cap/tab 1173.54 108.99
Amoxicillin 500mg Cap/tab Amoxicillin 500mg Cap/tab 249.70 10.73 3.79
Atenolol 50mg Cap/tab 54.84 Atenolol 50mg Cap/tab 906.00 82.32 89.73
Captopril 25mg Cap/tab 254.11 30.92 Captopril 25mg Cap/tab 1536.62 14.55 32.16
Ceftriaxone 1g/ vial injection 4.37 0.19 Ceftriaxone 1g/ vial injection 35.62 16.83 32.91 0.24 21.89
Ciprofloxacin 500mg Cap/tab 27.82 Ciprofloxacin 500mg Cap/tab 1365.29 72.29 29.54 27.25
Co-trimoxazole 8 + 40mg/ml Susp. Co-trimoxazole 8 + 40mg/ml Susp. 1744.54 59.09
Diazepam 5mg Cap/tab Diazepam 5mg Cap/tab 238.31 25.87
Diclofenac 50mg Cap/tab Diclofenac 50mg Cap/tab 4215.79 2394.29 85.95 158.97 87.91
Glibenclamide 5mg Cap/tab 148.14 Glibenclamide 5mg Cap/tab 76.19 237.02 24.44
Omeprazole 20 mg Cap/tab 5.97 Omeprazole 20 mg Cap/tab 2045.19 22.05 7.00
Paracetamol 24 mg/ml Susp. Paracetamol 24 mg/ml Susp. 901.14 102.22
Salbutamol 0.1mg/dose inhaler 249.71 402.39 7.45 Salbutamol 0.1mg/dose inhaler 608.66 456.71 1414.90 7.98 3.85
Simvastatin 20mg Cap/tab Simvastatin 20mg Cap/tab 430.34 52.87
PUBLIC SECTOR PRIVATE SECTOR
Low price generics Ghana Jordan Kyrgyzstan Peru Philippines Uganda Low price generics Ghana Jordan Kyrgyzstan Peru Philippines Uganda
Amitryptyline 25mg Cap/tab 433.54 134.00 6.85 1.00 Amitryptyline 25mg Cap/tab 137.94 14.32 6.59
Amoxicillin 500mg Cap/tab 18.80 15.02 39.84 1.25 1.78 0.36 Amoxicillin 500mg Cap/tab 26.32 147.39 45.27 1.79 2.63 1.26
Atenolol 50mg Cap/tab 110.28 19.59 21.30 0.00 20.30 0.86 Atenolol 50mg Cap/tab 110.28 450.55 24.98 42.23 27.88 4.32
Captopril 25mg Cap/tab 34.92 25.78 0.87 13.30 1.40 Captopril 25mg Cap/tab 1268.88 24.86 1.45 12.37 10.27
Ceftriaxone 1g/ vial injection 4.84 1.39 0.83 0.64 0.05 1.09 Ceftriaxone 1g/ vial injection 4.66 13.28 1.18 3.46 0.12 2.19
Ciprofloxacin 500mg Cap/tab 60.12 17.16 41.67 1.18 12.84 0.68 Ciprofloxacin 500mg Cap/tab 45.09 301.63 45.13 1.72 10.22 3.03
Co-trimoxazole 8 + 40mg/ml Susp. 118.45 108.21 326.28 80.30 24.14 0.89 Co-trimoxazole 8 + 40mg/ml Susp. 177.67 284.04 481.39 718.44 19.78 1.79
Diazepam 5mg Cap/tab 8.43 40.92 89.10 1.20 0.56 Diazepam 5mg Cap/tab 8.43 55.36 114.80 1.20 3.40
Diclofenac 50mg Cap/tab 374.05 79.73 153.71 5.61 0.57 Diclofenac 50mg Cap/tab 224.43 2018.20 312.15 4.36 68.52 4.40
Glibenclamide 5mg Cap/tab 208.01 69.28 613.68 1.73 72.29 1.28 Glibenclamide 5mg Cap/tab 208.01 1122.31 580.25 2.60 118.51 12.22
Omeprazole 20 mg Cap/tab 132.43 29.11 23.72 0.55 0.39 Omeprazole 20 mg Cap/tab 132.43 878.15 26.51 1.76 2.62 3.11
Paracetamol 24 mg/ml Susp. 41.91 65.55 67.36 38.58 1.22 Paracetamol 24 mg/ml Susp. 32.80 94.68 587.55 134.72 48.20 1.93
Salbutamol 0.1mg/dose inhaler 328.01 103.00 239.46 113.13 1.26 Salbutamol 0.1mg/dose inhaler 445.16 221.62 241.19 935.47 6.04 1.51
Simvastatin 20mg Cap/tab 13.47 0.53 Simvastatin 20mg Cap/tab 1396.88 329.60 137.36 4.65 6.04
Notes:
No consumer price data available for Zambia.
Empty cells = data not available
Key findings:
For the few data available on consumer price ratios for originator medicines it is clear that the prices are much higher than international reference prices for selected generic medicines (ranging from 6 to 402 times higher in the public sector and from 4 to 2045 times
higher in the private sector). Exception is ceftriaxone 1g/ vial injection which costs less than the international reference price in the Philippines. Differences in consumer prices for the same originator medicine are sometimes enormous between the pilot countries.
Originator private sector consumer prices are extremely high in Jordan while they are less high in Peru, the Philippines and Uganda (with some exceptions for certain medicines).
The consumer prices of the originator "Ceftriaxone 1g/ vial injection" in both the public and private sector and for all pilot countries are among the lowest of all medicines listed.
The consumer price ratios for the selected low generic medicines in the public and private sector show the best results for Uganda: the prices range from being cheaper (in the public sector) than the international reference price to being 12 times higher (in the private
sector). As for the originator consumer prices, the consumer prices of the low generic "Ceftriaxone 1g/ vial injection" in both the public and private sector and for all pilot countries are among the lowest of all medicines listed.
30 November 2010 www.medicinestransparency.org 7
MeTA Baseline Pharmaceutical sector scan - Cross-country analysis
Worksheet "Consumer prices" - Explanatory notes
Indicators 16.1-16.14: Consumer prices of Medicines
For the consumer prices, the following additional calculations were made to have median price ratios:
• The "raw" country median prices were converted to USD, using the average exchange rate of the first quarter
of 2010 (January-March), which was selected as the mid-point for the data collection period (ranging from
September 2009 until June 2010).
Exchange rate Q1 Currency Data collected
EXCHANGE RATES
2010
1 USD = 1.4071 Ghanaian Cedi Nov 2009-Feb 2010
0.7041 Jordan Dinar June 2010
44.5137 Kyrgyzstan Som April-June 2010
2.8169 Peru Nuevos Soles June 2010
45.8543 Philippines Pesos < Jan 2010
1,995.7506 Ugandan Shilling May-June 2010
4,562.6927 Zambia Kwacha June 2010
Source: www.oanda.com. Bid prices for First Quarter of 2010 (covering January to March): average rate for period
Sept 2009-June 2010 cannot be calculated; the oanda system does it year per year).
• Those median USD consumer prices were divided by the corresponding median supplier prices for each of the
medicines. The median supplier prices come from the MSH International Drug Price Indicator Guide - 2009
edition, List III - Price Comparison Form (Supplier Prices Only, pages SP1 till SP36) & (Buyer Prices Only, pages
BP1 till 44), to be downloaded from http://erc.msh.org/dmpguide/pdf/DrugPriceGuide_2009_en.pdf.
• The result gives the ratio of consumer prices to international reference prices for selected originator and low
price generic medicines in the public and private for-profit sector (based on WHO/HAI methodology).
Notes:
• Uganda: Ind. 16.9: Amoxicillin 250 mg cap/tab (instead of 500 mg).
• Zambia: no price survey data collected.
• Empty cells: no data available.
• Data comparability may be biased because of price data of different years:
Country Source Year of data collection
Ghana WHO Pharmaceutical Situation 2009
Assessment (Level II) 2009
Jordan WHO Pharmaceutical Situation 2010
Assessment (Level II) 2010
Kyrgyzstan Retail networks ―Neman- 2009 & 2010
Pharm ltd., Bi-med ltd., 2010
Semi-annual health facilities
reports on procured drugs for
2009
Peru DIGEMID Price Observatory June 2010
Philippines HAI Survey 2005 February 2005
16.13: HAI Survey 2002 2002
Uganda National Medical Stores 2010
16.3/4/5/13: private pharmacy
in Kampala
Zambia n.a.
30 November 2010 www.medicinestransparency.org 8
MeTA Baseline Pharmaceutical sector scan - Cross-country analysis
Ind. 21.1-21.14: Procurement Prices of Medicines on HAI Global Core List
Median price ratios are presented here.
PUBLIC SECTOR
Originator medicines Ghana Jordan Kyrgyzstan Peru Philippines Uganda
Amitryptyline 25mg Cap/tab
Amoxicillin 500mg Cap/tab 4.80
Atenolol 50mg Cap/tab 5.30
Captopril 25mg Cap/tab 20.50 9.30
Ceftriaxone 1g/ vial injection 19.10
Ciprofloxacin 500mg Cap/tab 33.10
Co-trimoxazole 8 + 40mg/ml Susp. 7.20
Diazepam 5mg Cap/tab 4.19 62.30
Diclofenac 50mg Cap/tab 72.50
Glibenclamide 5mg Cap/tab 33.30
Omeprazole 20 mg Cap/tab 2.17 16.60
Paracetamol 24 mg/ml Susp. 5.10
Salbutamol 0.1mg/dose inhaler 1.96 3.20
Simvastatin 20mg Cap/tab 10.10
PUBLIC SECTOR
Low price generics Ghana Jordan Kyrgyzstan Peru Philippines Uganda
Amitryptyline 25mg Cap/tab 1.07 0.08 0.69
Amoxicillin 500mg Cap/tab 0.80 1.11 2.00 0.09 0.70 0.30
Atenolol 50mg Cap/tab 2.32 0.48 0.80 0.00 2.50 1.02
Captopril 25mg Cap/tab 2.00 0.02 1.60 1.19
Ceftriaxone 1g/ vial injection 3.41 0.87 0.80 0.99 0.60 0.91
Ciprofloxacin 500mg Cap/tab 2.48 0.91 9.67 0.09 0.70 0.58
Co-trimoxazole 8 + 40mg/ml Susp. 2.08 1.60 0.88 1.20 0.75
Diazepam 5mg Cap/tab 0.67 2.99 0.04 9.40 0.48
Diclofenac 50mg Cap/tab 1.45 2.60 4.00 4.00 0.40
Glibenclamide 5mg Cap/tab 1.69 4.14 0.01 2.30 1.05
Omeprazole 20 mg Cap/tab 2.53 0.78 0.84 0.56 1.60 0.30
Paracetamol 24 mg/ml Susp. 0.74 0.65 1.00 1.05
Salbutamol 0.1mg/dose inhaler 0.83 1.51 1.17 2.58 2.80 1.07
Simvastatin 20mg Cap/tab 4.90 0.38 1.73 1.40
Notes:
No procurement price data available for Zambia.
Empty cells = data not available.
Key findings:
• For the originator medicines the cross-country comparison is limited because, apart from data for the Philippines, only four median
price ratios are given. Procurement prices for low price generics are often more expensive than the international reference price (no
analysis made for Peru and Uganda, until it is clear what to do with the data): Diclofenac e.g. is 1.4 times more expensive in Ghana
and Peru, 2.6 times more expensive in Kyrgyzstan and 4 times in the Philippines.
•There is no clear pattern to be distinguished that certain low price generics are always procured at a much higher or lower price.
30 November 2010 www.medicinestransparency.org 9
MeTA Baseline Pharmaceutical sector scan - Cross-country analysis
Worksheet "Procurement prices" - Explanatory notes
Indicators 21.1-21.14: Procurement price ratio
This indicator is the ratio of local procurement prices to international reference procurement prices for selected originator and
low price generic medicines in the public sector (based on WHO/HAI methodology).
Notes:
• No clear indication on which procurement prices were collected, i.e. whether they are FOB, CIF, or other procurement prices.
• Uganda: Ind. 16.9: Amoxicillin 250 mg cap/tab (instead of 500 mg). The "procurement prices" from the data collection form
have been converted to USD and divided by the MSH international reference median supplier price.
• Zambia: no price survey data collected.
• Empty cells: no data available.
• The sources for the MPR use different years and therefore some of the cross-country findings may be biased:
Country Source Year of data collection
Ghana WHO Pharmaceutical Situation 2009
Assessment (Level II) 2009
Jordan WHO Pharmaceutical Situation 2010
Assessment (Level II) 2010
Kyrgyzstan Semi-annual health facilities 2009 & 2010
reports on procured drugs for
2009
Peru MOH 2009
Philippines Public Sector Procurement (HAI) July 2008
Uganda National Medical Stores, 2010
Procurement Department
Zambia n.a.
30 November 2010 http://www.medicinestransparency.org/ 10
