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Disclosure Status of Pharmaceutical Sector Data Part of Component 1 of the MeTA Baseline Assessments

UGANDA July 2010

The Medicines Transparency Alliance Uganda

Uganda Assessment of Pharmaceutical Data Disclosure

Data
Collection
Tool
developed
by:
 WHO
Harvard
Collaborating
Center
in
Pharmaceutical
Policy
 On
behalf
of
 The
Medicines
Transparency
Alliance
 






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Uganda Assessment of Pharmaceutical Data Disclosure

Table of Contents I. INTRODUCTION................................................................................................................ 5
 II. KEY QUESTIONS TO ANSWER RELATED TO DATA DISCLOSURE ............................. 6
 III. INFORMATION CATEGORIES AND POSSIBLE DATA SOURCES ................................ 7
 1. Medicines Registration and Quality Assurance .............................................................. 7
 1.1 Market registration procedures and registration status of all medicines.................... 7
 1.2 Good manufacturing practice (GMP) for domestic and foreign manufacturers.......... 7
 1.3 Quality assurance processes in public and non-profit tenders .................................. 8
 1.4 Quality assurance data during registration or procurement ...................................... 8
 1.5 Routine quality testing and adverse event monitoring .............................................. 8
 2. Medicine Availability ...................................................................................................... 9
 2.1 Standard treatment guidelines ................................................................................. 9
 2.2 Essential medicines list ............................................................................................ 9
 2.3 Pharmaceutical patents held in the country ............................................................ 10
 2.4 Volume and value of medicines procured in the public and non-profit sectors........ 10
 2.5 Volume and value of medicines supplied in the private sector................................ 11
 2.6 Availability of medicines to consumers ................................................................... 11
 2.7 Routine audits for public, private, and non-profit medicines outlets ........................ 12
 3. Medicine Prices ........................................................................................................... 12
 3.1 Consumer and ex-manufacture prices of medicines in the public, private, and nonprofit sectors ................................................................................................................ 12
 3.2 Public sector medicines procurement prices .......................................................... 13
 3.3 Medicines price components in the public, non-profit, and private sectors ............. 13
 4. Medicine Promotion ..................................................................................................... 14
 4.1 Medicines promotion regulations, policies, and industry practices .......................... 14
 IV. FORMS FOR SUMMARIZING DATA DISCLOSURE STATUS ...................................... 15
 1. Medicines Registration and Quality Assurance ............................................................ 15
 1.1 Market registration procedures and registration status of all medicines.................. 15
 1.2 Good manufacturing practice (GMP) for domestic and foreign manufacturers........ 17
 1.3 Quality assurance processes in public and non-profit tenders ................................ 18
 1.4 Quality assurance data during registration or ......................................................... 19
 1.5 Routine quality testing and adverse event monitoring ............................................ 20
 2. Medicine Availability .................................................................................................... 21
 2.1 Standard treatment guidelines ............................................................................... 21
 2.2 Essential medicines list .......................................................................................... 22
 2.3 Pharmaceutical patents held in the country ............................................................ 23
 2.4 Volume and value of medicines procured in the public and non-profit sectors........ 24
 2.5 Volume and value of medicines supplied in the private sector................................ 25
 2.6 Availability of medicines to consumers ................................................................... 26
 2.7 Routine audits for public, private, and non-profit medicines outlets ........................ 27


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Uganda Assessment of Pharmaceutical Data Disclosure 3. Medicine Prices ........................................................................................................... 28
 3.1 Consumer and ex-manufacture prices of medicines in the public, private, and nonprofit sectors ................................................................................................................ 28
 3.2 Public sector medicines procurement prices .......................................................... 29
 3.3 Medicines price components in the public, non-profit, and private sectors ............. 30
 4. Medicine Promotion ..................................................................................................... 31
 4.1 Medicines promotion regulations, policies, and industry practices .......................... 31


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Uganda Assessment of Pharmaceutical Data Disclosure

I. Introduction MeTA pilot countries are developing strategies to promote greater transparency and accountability regarding policies, practices, and outcomes in the pharmaceutical sector. They have committed to disclosing, analyzing, and using over time data in the following four core areas described in the MeTA project document: 1. Medicines registration and quality assurance 2. Availability of medicines 3. Price of medicines 4. Policies and practices concerning the promotion of medicines For each core area, disclosed information should cover policies – the laws and regulations that are in place; practices – suggested procedures to follow and actual practices; and results –achievements in the core area. 1 The objectives of describing the current disclosure status of information in the core areas are to: (1) enable the national MeTA stakeholders to prioritize potential MeTA country activities to facilitate progressive disclosure over time; and (2) create a baseline against which changes in transparency and disclosure during the MeTA pilot implementation can be measured. This brief describes a process for accounting of data disclosures as envisioned by MeTA. The first section provides a brief framework for exploring disclosure status in a systematic way. The second section reviews the rationale for disclosing each type of pharmaceutical sector data and gives an overview of some possible data sources and key items to be disclosed in each area of disclosure. The third section provides a series of tables for collecting and presenting data on the disclosure status of key categories of pharmaceutical sector information. To aid understanding, this information on data disclosure should be supplemented by contextual information on the medicines supply chain, access, price, affordability, and rational use of medicines. These data will be collected as part of an accompanying Pharmaceutical Sector Scan that will also be implemented as part of the baseline assessment. These contextual data will aid in the interpretation of the information on the status of disclosed data.

1

Medicines Transparency Alliance. Implementing our pilot phase. Document presented at the MeTA launch, May 2008

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Uganda Assessment of Pharmaceutical Data Disclosure

II. Key Questions to Answer Related to Data Disclosure In completing its baseline summary of disclosure, each MeTA country team should answer the questions below for each of the pharmaceutical sector topics targeted in the MeTA pilot phase project document. This information can be organized in a brief summary document (see Section 3) that will allow for convenient display of results for each topic. The summary for each pharmaceutical sector topic will cover the following issues: Policies

• • •

Do relevant laws and/or policies exist? Are these laws and/or policies published? Do laws and/or policies exist to make the relevant data publicly available?

Practices

• • • • •

Are required and/or recommended practices published? How are those practices implemented and enforced? What data sources exist and how are they organized? Where do the data reside and who has access? What is the quality of published data?

Results Are results, achievements, or outcomes disclosed? • What are the disclosed data used for and by whom? • What barriers exist to using the disclosed data more widely? • Which strategies might encourage expanded data access and use? During the process of conducting the baseline scan of data disclosures, MeTA country teams should obtain copies of any key pharmaceutical sector data that have already been publicly disclosed.. These disclosures may exist in the form of available publications, reports, lists, databases, or websites. The local team should append these disclosed data or their location to the summary report.

•

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Uganda Assessment of Pharmaceutical Data Disclosure

III. Information Categories and Possible Data Sources 1. Medicines Registration and Quality Assurance 1.1 Market registration procedures and registration status of all medicines Rationale Maintaining a transparent and organized process for registering medicines allowed to be used in a country is essential for ensuring that only high quality medicines are available on the local market. Through the registration process, manufacturers and importers demonstrate their compliance with pharmaceutical sector regulations on registered products. Drug supply managers and clinicians need to know which medicines are registered for use so that they can make appropriate therapeutic choices. Possible data sources

• • • • •

Explicit policies guiding registration along with decision making criteria (initial and renewal, patented and generic products) Information on registration fees, steps in registration process, regulations for general and/or restricted registration, for expedited review Policies and processes for de-registration of registered products Information on decision makers and potential conflicts of interest Dossiers submitted for medicines registration with dates and disposition

Key disclosure data

• • • •

Detailed information on process for registering and de-registering medicines List of registered products by therapeutic class, patent status, and registration date Average length of time required to register a product, both patented and generic Average cost to register a product, both patented and generic

1.2 Good manufacturing practice (GMP) for domestic and foreign manufacturers Rationale A key prerequisite to the production of safe medicines is adherence by manufacturers to Good Manufacturing Practices (GMP). Monitoring GMP adherence is a key function of the drug regulatory agency. Possible data sources

• • • •

Regulations concerning GMP criteria and certification processes for domestic and foreign manufacturers GMP compliance monitoring procedures GMP certificates for domestic and foreign manufacturers Reports of inspections of manufacturing plants for compliance with GMP

Key disclosure data

• •

List of GMP compliant manufacturing plants of suppliers/manufacturers and dates of last inspection List of manufacturing plants that failed GMP inspection and dates of inspection and recommendations to plants

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Uganda Assessment of Pharmaceutical Data Disclosure 1.3 Quality assurance processes in public and non-profit tenders Rationale Making efficient, cost-effective, and safe procurement decisions requires information on the quality and reliability of medicines suppliers. Public disclosure of tender results can lead to more assured medicines quality and more cost-effective procurement. Possible data sources

• • • •

Explicit criteria for supplier pre-qualification Procedures for pre-qualifying suppliers Ministry of Health, government procurement agency, or drug regulatory authority reports Non-profit medicine supply system reports

Key disclosure data

• • •

List of pre-qualified suppliers for public, non-profit, or private sector tenders List of suppliers who failed to meet pre-qualification standards in the past Proportion of medicines by volume and value procured from prequalified suppliers in public sector and non-profit medicines supply systems

1.4 Quality assurance data during registration or procurement Rationale Prescribers, patients, and procurement agencies need to be able to trust the quality of medicines in the market place. Safe, appropriate, and cost-effective decisions depend on documented product quality assurance, specifically for generic products. Possible data sources

• • • •

Regulations and procedures for assuring quality of domestic and imported products during registration or procurement processes Product quality assurance documents (both domestically produced and imported products) Bioavailability studies (generic products) Reports of violations of quality standards

Key disclosure data

•

List of products that failed quality assurance procedures during registration or procurement processes and dates of failure and steps taken to address problems

1.5 Routine quality testing and adverse event monitoring Rationale Assuring safe use of medicines requires routine surveillance to detect substandard and counterfeit products, as well as routine reporting of adverse events identified after a drug has been marketed. The drug regulatory authority needs to establish systems to monitor drug quality and adverse events, and make these results publicly available. Possible data sources

• • • • •

Regulations and procedures for testing the quality of products in the market Regulations and procedures for monitoring and reporting adverse events Routine and ad hoc reports of products tested by quality testing laboratories Reports of adverse events identified in post-marketing surveillance studies Data and reports from voluntary adverse event reporting systems

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Uganda Assessment of Pharmaceutical Data Disclosure Key disclosure data

• • •

Number of samples from the market that were sent to quality control laboratories by government inspectors for routine testing in last year List of products that failed quality testing, date of testing, and steps taken to resolve problem Number of adverse event reports that were submitted to the government adverse event reporting system in last year

2. Medicine Availability 2.1 Standard treatment guidelines Rationale Standard treatment guidelines are one strategy for ensuring the availability of appropriate medicines to treat common health problems. Evidence-based and up-to-date standard treatment guidelines (STG) for key illnesses can guide the therapeutic decisions of health providers and the formulary decisions of health institutions and systems. STGs can be tailored for different levels of care and used as the basis for monitoring prescribing according to STGs. Possible data sources

• • • • •

Policies and procedures for creating and updating guidelines Procedures for selecting national STG committee members Processes to declare and document conflict of interest of STG committee members Processes for disseminating guidelines Policies and regulations to enforce or encourage guideline use (public and private sector)

Key disclosure data

• •

List of members of national STG committee with qualifications and affiliations Existing STGs for key adult and paediatric illnesses, including organization that created STG and year last updated

2.2 Essential medicines list Rationale A national or institutional essential medicines list (EML) provides guidance about the medicines recommended to treat common health problems seen in that setting. EMLs typically include all of the medicines recommended on STGs, as well as other medicines needed to address most of the clinical problems seen at a given level of care. By prescribing from an EML, health providers are more likely to offer the most cost-effective and affordable care. An essential medicines list also structures the process of procurement and pharmacy management, helping to ensure the availability of appropriate medicines. Possible data sources

• • • •

Policies and procedures for creating and updating EML Procedures for selecting EML committee members Processes to declare and document conflict of interest of EML committee members and other stakeholders Processes for disseminating EMLs

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Uganda Assessment of Pharmaceutical Data Disclosure

•

Policies and regulations to enforce or encourage EML use (in prescribing, procurement, supply management)

Key disclosure data

• •

List of members of national essential medicines committee with qualifications and affiliations Essential medicines lists for defined levels of care (primary health centre, secondary or district hospital, tertiary care centre) and year of last update

2.3 Pharmaceutical patents held in the country Rationale Policy makers and regulators need to be able to determine the patent status of products on the market to ensure compliance with intellectual property (IP) agreements and patent regulations, and to develop appropriate incentives for generic importation and manufacturing. Possible data sources

• • •

Laws and regulations governing IP, pharmaceutical patents, and market exclusivity Documentation of the status of relevant IP and trade agreements Explicit procedures governing filing for patents and market exclusivity arrangements

Key disclosure data

•

List of registered medicines, their patent status, and the date of patent expiry (individually and by therapeutic class)

2.4 Volume and value of medicines procured in the public and non-profit sectors Rationale Public sector policy makers and regulators need to know which products are used, in what volumes, and at what cost in order to project need, identify potential over- and underuse, and design policy interventions to increase use of desired and decrease use of undesired alternative products. Transparent procurement data are also useful for ensuring accountability of public resources. The non-profit health sector operates like a quasigovernmental system in many countries, filling gaps in the public health delivery system. Non-profit institutions also receive tax advantages in most countries in return for their role in promoting the public good. Disclosure of procurement data from non-profit institutions can encourage greater accountability. Possible data sources

• • • •

Government budget documents Policies and regulations governing the disclosure of drug procurement or utilization data in the public and non-profit sectors Ministry of Health, Central Medical Stores, regional, or institutional medicines procurement or utilization reports Non-profit sector medicines procurement or utilization reports

Key disclosure data

• •

Government budgets for health care and pharmaceuticals for last fiscal year Type, volume, and value of medicines procured in the public and non-profit sectors (by region, by facility level, by innovator vs. generic, by therapeutic category)

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Uganda Assessment of Pharmaceutical Data Disclosure 2.5 Volume and value of medicines supplied in the private sector Rationale Policy makers and regulators need to know which products are used in the health system as a whole in order to understand trends in use, identify possible over- and underuse, and develop effective pharmaceutical policies. Detailed data on the quantity and price of medicines imported, manufactured, and sold in the private sector have commercial value and are generally considered confidential. However, some level of reporting of private sector pharmaceutical supply system data is often required to comply with drug regulatory and tax regulations. Possible data sources:

• • •

Policies and regulations governing the disclosure of drug supply data in the private sector Procedures and practices concerning release of private sector data on drug importation, manufacturing, and sales Data on type, volume and value of products imported, manufactured, or sold (by region; by therapeutic category, by level of the supply system)

Key disclosure data

• •

Type, volume, and value of medicines imported in the private sector (by innovator vs. generic, by therapeutic category) Type, volume, and value of medicines supplied in the private sector (at import vs. wholesale vs. retail level, by innovator vs. generic, by therapeutic category)

2.6 Availability of medicines to consumers Rationale To ensure effective treatment, appropriate medicines need to be available where and when patients seek care. Patients who seek care in public health facilities can expect that essential medicines recommended in relevant STGs and on the EML should be available at all times; poor availability of medicines is one common reason why patients bypass the public sector. Patients who seek care in the private or non-profit sector can expect adequate availability of medicines of reasonable quality. Possible data sources

• • • • •

Policies and procedures governing the procurement and stocking of essential medicines in public and non-profit health facilities Stock records for key medicines from public and non-profit health facilities (by region, by facility type, by therapeutic category) Documented follow-up on reports of pharmacy stock-outs in public health facilities, including time to resolution IMS data or other surveys of availability of medicines in private importers, wholesalers, or private retail pharmacies WHO-HAI medicines price or WHO Level II monitoring surveys

Key disclosure data

• •

Percent availability in public sector or non-profit health facilities of a list of key essential medicines (by region, by product, by innovator vs. generic, by therapeutic class, if available) Percent availability in private retail pharmacies of a list of key essential medicines (by region, by product, by innovator vs. generic, by therapeutic class, if available)

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Uganda Assessment of Pharmaceutical Data Disclosure 2.7 Routine audits for public, private, and non-profit medicines outlets Rationale Routine audits of medicines outlets are needed to ensure adequate compliance with laws and regulations concerning physical environment, types of products stored, staffing, record keeping, sales practices, and accounting. Possible data sources

• • •

Laws and regulations governing the operation of a pharmacy or medicines store (by public, non-profit, and private sector) Regulations and procedures for auditing practices in medicines stores Ministry of Health or drug regulatory agency reports

Key disclosure data

• • •

Number, characteristics, training, and case load of drug regulatory agency auditors Number and percent of facilities audited in last year (by region, by type of facility) Number, type, and resolution of violations reported during audits

3. Medicine Prices 3.1 Consumer and ex-manufacture prices of medicines in the public, private, and nonprofit sectors Rationale Prices charged in public, non-profit, and private sector medicines outlets determine the affordability of medicines for consumers. End-user prices are a function both of the original price charged by a manufacturer (ex-manufacture price) and various mark-ups that are added on as the medicine proceeds through the supply system. Some countries regulate end-user price or allowable mark-ups at various points in the supply chain. Medicines are often provided free or with high levels of subsidy in public sector health facilities. Knowledge about the comparative prices of alternative products, or about the prices of the same product in different outlets, can guide consumers to more cost-effective care. Possible data sources

• • • • • • •

Laws and regulations governing ex-manufacture and end-user pricing of medicines in the public, non-profit, and private sectors Procedures for auditing compliance with pricing regulations and procedures for handling violations Results of audits for compliance with pricing regulations Insurance program policies and procedures for medicines reimbursement Results of WHO-HAI medicines price surveys or of routine public or private medicines price monitoring systems Ex-manufacture price from manufacturers or importers/wholesalers 2 (both innovator and available generic versions) Insurance system reimbursement data

2

Disclosing ex-manufacturer prices by manufacturers or importers/wholesalers may be a sensitive issue in some circumstances. Aggregation of individual products into an average price per essential medicine, or the use of an intermediate agency (IMS, University, or consultant) might help obtain such data. Even if data cannot be disclosed, the arguments and potential process for disclosure could be discussed.

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Uganda Assessment of Pharmaceutical Data Disclosure Key disclosure data

• • • • •

Private sector retail prices for list of key essential medicines (by region, by innovator vs. generic versions) Private sector ex-manufacture price for a list of key essential medicines as above Prices charged to patients in public sector or non-profit health facilities for list of key essential medicines (by region, by level of facility, by innovator vs. generic versions), including visit fees or dispensing fees if applicable Affordability of medicines to treat key acute and chronic health problems in public, private, and non-profit sectors, with prices expressed in relation to a standard metric such as the wages of the lowest paid government worker Amount charged and reimbursed to patients by insurance programs for list of key essential medicines (by insurance program type, by innovator vs. generic versions)

3.2 Public sector medicines procurement prices Rationale The prices that public sector agencies and health facilities pay to procure medicines are a key determinant of their ability to afford the medicines they need, and in some systems, of the prices charged to patients. Procuring medicines requires specialized technical skills that may not be present in all settings, especially in decentralized health systems. Transparent procurement processes, effective negotiation, and pooled procurement may decrease public procurement prices. Transparent procurement data enables public sector policy makers and system managers to benchmark bid prices, track prices over time, estimate budget requirements, and assess the overall efficiency of the procurement process. Possible data sources

• • • •

Laws and regulations governing the disclosure of public sector medicines procurement prices Notifications about explicit procedures to be followed in handling bids in the public procurement process Audits for compliance with public medicines procurement regulations Ministry of Health medicines procurement records

Key disclosure data

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Public sector procurement prices for list of key essential medicines (by region, by level of care, by administrative unit, by product, by therapeutic class, if available)

3.3 Medicines price components in the public, non-profit, and private sectors Rationale Taxes, tariffs, mark-ups, and other charges levied as medicines move through the supply chain can add substantially to the costs of medicines to consumers. To develop effective policies to make medicines more affordable, government policy makers need information about the levels and variations in medicines price components in both the public and nonprofit sectors; countries that regulate private sector mark-ups need similar information from the private supply system. Possible data sources

• •

Laws and regulations governing mark-ups of medicines in the public and non-profit sectors (and in the private sector, if applicable) Procedures for auditing compliance with regulations concerning mark-ups in the medicines supply chain and procedures for handling violations

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Uganda Assessment of Pharmaceutical Data Disclosure

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Results of audits for compliance with regulations concerning price mark-ups WHO-HAI price components studies

Key disclosure data

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Data on price components (duties, taxes, mark-ups and other charges) for key essential medicines, both domestically manufactured and imported (by region, by sector, by level of care, and by therapeutic class)

4. Medicine Promotion 4.1 Medicines promotion regulations, policies, and industry practices Rationale Through their promotional activities and materials, pharmaceutical manufacturers are the main source of information on medicines in many countries. Many countries have mandatory or voluntary codes of conduct governing the promotion of medicines to institutional purchasers, prescribers, retail sellers, and consumers. Some countries vet advertisements and promotional materials for accuracy. It is crucial that promotional activities comply with codes on ethical behaviour and balanced information content; inappropriate or unethical promotion can contribute to inefficient or unsafe patterns of care. Possible data sources

• • • • •

Laws and regulations on pharmaceutical industry promotion, including codes of conduct adopted by professional organizations International and domestic pharmaceutical manufacturers’ codes of conduct Public procurement agencies’ standard operating procedures related to relationships with representatives of pharmaceutical manufacturers and wholesalers Procedures for handling complaints, and for identifying, sanctioning, and publicizing violations of codes Documentation on the membership of monitoring committees and declarations of potential conflicts of interest

Key disclosure data

• • •

List of manufacturers and distributors that subscribe to internationally or nationally recognized codes of conduct List of individuals with their affiliations who are on the national committee to monitor adherence to industry codes of conduct Reports of numbers and types of complaints submitted to the national monitoring committee regarding promotional practices, numbers of violations, and resolution of the complaints

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Uganda Assessment of Pharmaceutical Data Disclosure

IV. Forms for Summarizing Data Disclosure Status 1. Medicines Registration and Quality Assurance 1.1 Market registration procedures and registration status of all medicines Sources:

Guidelines, Policies

Policies: Do laws/policies exist? Are they published? Do associated regulations exist? The law (called the National Drug Policy and Authority Act [Cap 206]), and is published Twos regulations available namely: • The National Drug Policy and Authority (Certificate of Suitability of Premises) Regulations • The National Drug Policy and Authority (Issue of Licences) Regulations New regulations are being developed. Where additional regulations are needed, these are subsequently developed and disseminated to stakeholders after following a consultative process

Practices: Are procedures published? How enforced? Which data exist? Who has access? Procedures are often published, for example Guidelines for registration of medicines in Uganda are available. Those that are not published are available on request from NDA. The National Drug Authority (NDA) enforces procedures. Data: List of registered products by therapeutic class, patent status, and registration date, and the associated costs

Results: Which data are available? Who uses data? Barriers to use? How to promote wider use? Drug Registers available and published on the NDA Website ( www.nda.or.ug) Guidelines for registration of all medicines Who uses the data: The data is used by stakeholders within the health sector, policy makers, pharmaceutical manufacturers, public and private importers, Non-Governmental Organizations and any other party with an interest in medicine availability and use within the country, and the general public

Barriers: Lack of access to up- to date information How to promote wider use: Avail the information electronically via the relevant websites, and ensure the availed information is complete, factual and up to date

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Uganda Assessment of Pharmaceutical Data Disclosure

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Uganda Assessment of Pharmaceutical Data Disclosure

1.2 Good manufacturing practice (GMP) for domestic and foreign manufacturers Sources:

Guidelines

Policies: Do laws/policies exist? Are they published? Do associated regulations exist? Yes, Laws and policies exist. The laws and policies are published Associated regulations do exist. These are updated regularly to ensure manufacturers comply with requirements NDA has the mandate to control manufacture of drugs: (sections 38, 39, 40 & 41 of the NDP/A Act Cap 206). No regulations for GMP exist, however, NDA GMP guidelines are in place.

Practices: Are procedures published? How enforced? Which data exist? Who has access? Procedures are published (those not published are accessed on request) and these are enforced through routine inspection visits These procedures are accessible to health professionals, regulators and parties interested in manufacturing of medicines for domestic use, or manufacturers of medicines by foreign manufacturers with intention to export to Uganda Available data include: • List of GMP compliant plants • List of GMP non-compliant plants

Results: Which data are available? Who uses data? Barriers to use? How to promote wider use? The number of domestic manufacturers licensed in Uganda The number of foreign manufacturers who meet the cGMP criteria and are approved by National Drug Authority Guidelines for approval of manufacturing plants • Inspection reports of all inspected plants • Data base for GMP inspected facilities Data is used by Inspectors and Drug Assessment and Registration officers.

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Uganda Assessment of Pharmaceutical Data Disclosure

1.3 Quality assurance processes in public and non-profit tenders Sources: Policies: Do laws/policies exist? Are they published? Do associated regulations exist? Two laws exist. 1) National Drug Policy and Regulations 2) The Public Procurement and Disposal of Public Assets Act, 2003. The two are published. The Regulation which exists is: The Public Procurement and Disposal of Public Assets Regulations, 2003.

Practices: Are procedures published? How enforced? Which data exist? Who has access? The procedures NMS follow are derived from the above two laws and are published. The procedures are enforced and regular internal and external audits are carried out to ensure that they are adhered to. Data which exists includes: Guidelines on the tendering process Guidelines on the recruitment of staff involved in the procurement process Guidelines on training of staff. Guidelines on receipt, storage and distribution of procured supplies Guidelines on disposal of rejected / damaged items Guidelines on recall of items from customers Who has access to data: Internal staff members. Other stakeholders (on request) Results: Which data are available? Who uses data? Barriers to use? How to promote wider use? Data available: Prequalified list of suppliers, list of suppliers with running contracts (both domestic and foreign), Performance of the procurement plan compared to the budgeted funds. Who uses Data? Internal staff members, other stakeholders like Ministry of Health (on request). Barriers to use? Lack of reliable real time information on a wider health sector for planning purposes. How to promote wider use: Have a central data bank where all matters concerning health can be accessed – a website can be developed.

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Uganda Assessment of Pharmaceutical Data Disclosure

1.4 Quality assurance data during registration or Sources:

NDA, Guidelines, policies

Policies: Do laws/policies exist? Are they published? Do associated regulations exist? No regulations or policies for QA of data during registration available yet.

Practices: Are procedures published? How enforced? Which data exist? Who has access? Several Standard Operating Procedures (SOPs) are available for internal use only.

Results: Which data are available? Who uses data? Barriers to use? How to promote wider use? Data available: Product dossier evaluation reports by first assessor and second assessor are available for each dossier evaluated. Letters to each applicant mentioning whether additional information is necessary or not are available.

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Uganda Assessment of Pharmaceutical Data Disclosure

1.5 Routine quality testing and adverse event monitoring Sources:

National Drug Authority

Policies: Do laws/policies exist? Are they published? Do associated regulations exist? Policy exists for routine testing of samples of drugs and medical devices and public health products e.g. long lasting insecticidal-mosquito nets (LLINs). Testing of samples is either routine or on riskbased analysis. Samples are collected either from the field or from ports of entry into Uganda upon importation. There are no laws on adverse event monitoring and the associated regulations exist but not yet in the public domain

Practices: Are procedures published? How enforced? Which data exist? Who has access? Standard Operating procedures are available for internal use. Sampling plans for different dosage forms and are available at sampling points and accessible by the importers and clearing and forwarding agents. Procedures are published and are enforced through routine pharmacovigilance. Procedures for adverse event reporting are in place but not published and not enforceable Data on adverse events reports is available Lists of drugs with their corresponding adverse events exist Access: There is open access to all this data but only experts may look at it Results: Which data are available? Who uses data? Barriers to use? How to promote wider use? Data available: Test reports and Certificates of analyses available Records of all raw (primary) test data including print-outs available for each batch of samples tested. Reports of passed and failed batches available. Reported incidents of adverse drug reactions Medicines causing adverse drug reactions Who uses data: Technocrats Barriers to use: Lack of education and sensitization of ADR monitoring Lack of resources to ensure regulators efficiently sensitize and carry out ADR Monitoring The major barrier to use is lack of knowledge and training to assess this data and draw meaningful conclusions out of it. Promoting wider use through: Sensitization of health workers and communities Periodic dissemination of results of ADR monitoring

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Uganda Assessment of Pharmaceutical Data Disclosure

2. Medicine Availability 2.1 Standard treatment guidelines Sources:

National Drug Authority, Ministry of Health

Policies: Do laws/policies exist? Are they published? Do associated regulations exist? Policies do exist and they are published Associated regulations are developed and published

Practices: Are procedures published? How enforced? Which data exist? Who has access? Procedures are published and enforced by the National Drug Authority and the Health Professional Councils and associations and the Ministry of Health Data: National Standard Clinical Guidelines, and various guidelines relating to management of specific conditions, and or handling of specific categories of medicines Access: Technically it is published and disseminated to Health workers, CSO’s, training institutions

Results: Which data are available? Who uses data? Barriers to use? How to promote wider use? Treatment Guidelines, Guidelines for use of medicines in management of health conditions Users of data: Health care professionals (including prescribers),policy makers, health managers, regulators Barriers to use: Poor dissemination of guidelines, non-availability of guidelines at health facilities, revision of guidelines takes too long Promoting wider use: Wide dissemination of guidelines to health care professionals, training institutions, policy makers and regulators, consider use of website

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Uganda Assessment of Pharmaceutical Data Disclosure

2.2 Essential medicines list Sources:

National Drug Authority, Ministry of Health

Policies: Do laws/policies exist? Are they published? Do associated regulations exist? An essential Drug List exists and it is published (EMLU 2007) NDA law establishes the EMLU and its addenda Pharmaceutical Sector Strategic Plan National Drug Policy 2002

Practices: Are procedures published? How enforced? Which data exist? Who has access? Procedures are published Enforcement is weak and as before: National Drug Authority, Ministry of Health, National Medical Stores have roles Who has access: Technically Health Care Professionals, training institutions, Policy makers and regulators. This is not available in the public domain.

Results: Which data are available? Who uses data? Barriers to use? How to promote wider use? Essential Medicines List exists and it is published (EMLU 2007) Users of data: Health professionals, training institutions, policy makers, regulators Barriers to use: Few copies are printed, delays in revision of essential drug list Promoting wider use: Wide dissemination to all stakeholders

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Uganda Assessment of Pharmaceutical Data Disclosure

2.3 Pharmaceutical patents held in the country Sources: Policies: Do laws/policies exist? Are they published? Do associated regulations exist? Yes. Patent Act is in place is in force. The Counterfeits Goods Bill and Competitions Bill are other associated legislations being developed.

Practices: Are procedures published? How enforced? Which data exist? Who has access? Procedures are laid out under the existing patents Act; procedures for enforcement are also spelt out under the law. Knowledge on patents is limited and their enforcement is largely unknown. Uganda’s current Patent Act is outdated and does not take into consideration the new undertakings by the WTO such as the Flexibilities of the TRIPS Agreement. Uganda also has limited capacity on issues of patents and Intellectual Property in general. Patents are examined through the African Regional Intellectual Property Organisation because of this limited capacity. Data exists: Patents registry- where the applications are filed and granted or rejected by the registrar in accordance with the existing law. Access: All data relating to the registered patent is available at the registry on payment of prescribed fee and is available to any interested person. Results: Which data are available? Who uses data? Barriers to use? How to promote wider use? Data relating to filed and registered or unregistered/rejected patents is available upon payment of a search fee prescribed under the parents Act. Who uses data: It is available to anyone interested in any patent grant, or in order to oppose any grant of patent on grounds as are indicated under the law. Barriers: It usually takes long for one to access this information because of the bureaucracy involved. Promote wider use by posting such data on the internet/web so that it is readily available to interested parties.

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Uganda Assessment of Pharmaceutical Data Disclosure

2.4 Volume and value of medicines procured in the public and non-profit sectors Sources:

National Drug Authority, Ministry of Health, National Medical Stores, Joint Medical Stores

Policies: Do laws/policies exist? Are they published? Do associated regulations exist? Laws and Policies relating to procurement exist and are available. Ministry of Health, Public Procurements and Disposal of Assets Authority(PPDA) and NDA, specifically for the public sector procurements.

Practices: Are procedures published? How enforced? Which data exist? Who has access? Procedures are published, and enforcement carried out by the PPDA, National Drug Authority and Ministry of Health

• Government budgets for health care and pharmaceuticals for last fiscal year

Results: Which data are available? Who uses data? Barriers to use? How to promote wider use? Data not readily available but information on value can be got from primary data in the districts , national medical stores, importers and NDA. Type, volume and value of medicines procured in the public sector. Government budgets for health care and pharmaceuticals for last fiscal year Access: This is through the National Medical Stores, Ministry of Health, NDA. Data users: Policy makers, Drug manufacturers , Importers Barriers to use: Inaccessibility of data especially volume value procured. Promote wider use by increasing accessibility to data (avail data on a freely accessible website)

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Uganda Assessment of Pharmaceutical Data Disclosure

2.5 Volume and value of medicines supplied in the private sector Sources:

National Drug Authority

Policies: Do laws/policies exist? Are they published? Do associated regulations exist? Laws and Policies do exist and they are published. Associated regulations exist

Practices: Are procedures published? How enforced? Which data exist? Who has access? Procedures are published. However, changes are not usually published in a timely manner. Access: Policy makers, researchers

Results: Which data are available? Who uses data? Barriers to use? How to promote wider use? Data Availability: All records available at NDA and by importers Type, volume, and value of medicines imported in the private sector (by innovator vs. generic, by therapeutic category) Data users: Policy makers, Drug manufacturers, Importers, researchers, regulators Barriers to use: Data unavailable to users Promote wider use by: Publish data, ensure up to date information is made available in a timely manner

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Uganda Assessment of Pharmaceutical Data Disclosure

2.6 Availability of medicines to consumers Sources: Policies: Do laws/policies exist? Are they published? Do associated regulations exist? Yes and are published during dissemination of the study and in the Annual health sector performance report

Practices: Are procedures published? How enforced? Which data exist? Who has access? Procedures to increase availability of medicines exist in these policies. The National Pharmaceutical Strategic Plan I sets goals of improving rational use of medicines, having good prescribing and dispensing habits, appropriate financing and pricing of medicines all aimed at increasing availability. However, medicines financing and supply systems are still poor and need to be improved in order to ensure an equitable availability of medicines to all. Data on availability exists in MoH/WHO/HAI quarterly pricing reports, in the WHO Level II Facility reports and Household survey report published in 2009. This data is mainly accessed by technical staff of MoH, CSOs, MeTA partners Results: Which data are available? Who uses data? Barriers to use? How to promote wider use? Data available: Level of stock out in the health units Data is available on percentage of public, private and mission facilities that have a basket of 40 essential medicines through the MoH/WHO/HAI quarterly pricing reports. The data is mainly used by MoH in planning and CSOs in advocacy. Barriers to use: Data is mainly technical and disseminated to only a small number of people Better dissemination methods need to be explored for the information to have wider impact.

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Uganda Assessment of Pharmaceutical Data Disclosure

2.7 Routine audits for public, private, and non-profit medicines outlets Sources:

National Drug Authority, Ministry of Health, Health Professional Council/Associations

Policies: Do laws/policies exist? Are they published? Do associated regulations exist? Laws exist though some are still weak Laws are published and associated regulations and guidelines exist. However some guidelines and regulations that would strengthen the sector are yet to be developed and approved.

Practices: Are procedures published? How enforced? Which data exist? Who has access? Procedures are published, though with weak enforcement. Access: Regulators and policy makers

Results: Which data are available? Who uses data? Barriers to use? How to promote wider use? Data: Reports of audits of public, private and non-profit sector Users of data: Regulators, policy makers, health professionals

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Uganda Assessment of Pharmaceutical Data Disclosure

3. Medicine Prices 3.1 Consumer and ex-manufacture prices of medicines in the public, private, and nonprofit sectors Sources: Policies: Do laws/policies exist? Are they published? Do associated regulations exist? There are no laws or policies governing consumer and ex-manufacture prices in Uganda. Based on liberalised market economy, different pharmaceutical retail outlets and manufacturers charge different prices. However, the Drug Policy states that the goal is to have medicines at the lowest possible price for consumers to access

Practices: Are procedures published? How enforced? Which data exist? Who has access? There are no procedures. Uganda is a free market economy and there is no pricing mechanism in place especially for medicines in the private sector. Existing data:

• Private sector retail prices for list of key essential medicines (by region, by innovator vs. generic versions) –Not available

• Private sector ex-manufacture price for a list of key essential medicines as above –Not available

• Prices charged to patients in public sector or non-profit health facilities for list of key essential • •

medicines (by region, by level of facility, by innovator vs. generic versions), including visit fees or dispensing fees if applicable-Available Affordability of medicines to treat key acute and chronic health problems in public, private, and non-profit sectors, with prices expressed in relation to a standard metric such as the wages of the lowest paid government worker-Not available Amount charged and reimbursed to patients by insurance programs for list of key essential medicines (by insurance program type, by innovator vs. generic versions)-Available

Results: Which data are available? Who uses data? Barriers to use? How to promote wider use? Data is available on medicine prices through the MoH/WHO/HAI quarterly pricing reports and WHO Level II Facility reports Available data Prices charged to patients in public sector or non-profit health facilities for list of key essential medicines Amount charged and reimbursed to patients by insurance programs for list of key essential medicines Users of data: Policy makers, Drug suppliers, Drug procuring agencies, Clinicians, Drug end users Barriers to use: Data not consistent and unavailable as a consolidated resource data base Promoting wider use: Consolidate data into an accessible resource data base

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Uganda Assessment of Pharmaceutical Data Disclosure 3.2 Public sector medicines procurement prices Sources: Policies: Do laws/policies exist? Are they published? Do associated regulations exist? Yes, laws governing public sector procurement exist and are published including: - ACTS SUPPLEMENT No. 1 17th January, 2003 - ACTS SUPPLEMENT to The Uganda Gazette No. 3 Volume XCVII dated 17th January, 2003.

Practices: Are procedures published? How enforced? Which data exist? Who has access? Yes, the procedures are published and available at PPDA. It is enforced by an ACT of parliament and the PPDA as an organisation does the enforcement through vetting/approving all public procurements to ensure that all public procurements conform to the set procedures. PPDA also entertains complaints. The available data includes procedures and guidelines e.t.c. The public has access to this. Existing data: Public sector procurement prices for list of key essential medicines Access to data: Public drug procuring agencies (National Medical Stores, Joint Medical Stores)

Results: Which data are available? Who uses data? Barriers to use? How to promote wider use? The available data includes records of all public procurements/tenders including prices, suppliers, tender documents, e.t.c. The suppliers and public have easy access to suspended vendors/suppliers, upcoming procurements and awards. Although PPDA has been promising to list the prices for commonly purchased items on website, this has never been translated into a reality. Some of key information like details of previous tender prices, e.t.c are only available on request. Proactive promotion of PPDA’s work and available information in the media would also help Data users: Drug manufacturers, Drug Importers, Health service providers Barriers to use: Data unavailable to users Promote wider use by: • Increasing accessibility to data by supporting PPDA to publish prices on the website • Link PPDA website to NDA and Uganda Revenue Authority website to allow wider access

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Uganda Assessment of Pharmaceutical Data Disclosure

3.3 Medicines price components in the public, non-profit, and private sectors Sources: Policies: Do laws/policies exist? Are they published? Do associated regulations exist? There are no laws or policies governing medicines price components in the private and non-profit sectors. The only requirement from NDA is to include FOB, freight and insurance break-down on the proforma invoices. These are not published. In the public sector, it is a requirement by PPDA for the different tenders within the public procurement to list the price components and this is available in the PPDA guidelines/regulations and in the various tender documents.

Practices: Are procedures published? How enforced? Which data exist? Who has access? There are no published procedures for private and non-profit. There are procedures governing public procurement and these are available at the PPDA and within the various tender documents. The public has access to PPDA guidelines.

Results: Which data are available? Who uses data? Barriers to use? How to promote wider use? There is limited data on price components. PPDA has promised list the price components for commonly purchased items on website but this has not been implemented yet. Barriers include amount of effort required to analysis the data and resources required to develop of an appropriate database or databases to manage the huge level of data. Promote wider usage by: - Supporting PPDA to develop database and publish the prices on the website. - Linking PPDA website to NDA and URA website to allow wider access

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Uganda Assessment of Pharmaceutical Data Disclosure

4. Medicine Promotion 4.1 Medicines promotion regulations, policies, and industry practices Sources:

National Drug Authority, Pharmaceutical Society of Uganda

Policies: Do laws/policies exist? Are they published? Do associated regulations exist? Laws, policies and associated regulations do exist

Practices: Are procedures published? How enforced? Which data exist? Who has access? Procedures not published but are availed to the user on request and are enforceable though enforcement is weak. Data: Regulations, Policies Access: Health professionals, Regulators, Policy makers, importers, manufacturers, retailers and other stakeholders involved in distribution of medicines to communities

Results: Which data are available? Who uses data? Barriers to use? How to promote wider use? Data available: Medicine Promotion Guidelines- the data is used by NDA staff and importers/ promoters of medicines. List of drugs that are eligible and ineligible for advertising

Users of data: Health professionals, regulators, policy makers, importers, manufacturers, retailers and other stakeholders involved in distribution of medicines to communities Wider use of information would be through having this information readily available to public through easier to access means such as the website.

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