Can NGOs regulate medicines markets? Social enterprise in wholesaling,and access to essential medicines

Background  

Citizens of high income countries rely on highly regulated medicines markets. However low income countries' impoverished populations generally struggle for access to essential medicines through out-of-pocket purchase on poorly regulated markets; results include ill health, drug resistance and further impoverishment. While the role of health facilities owned by non-governmental organisations (NGOs) in low income countries is well documented, national and international wholesaling of essential medicines by NGOs is largely unstudied. This article describes and assesses the activity of NGOs and social enterprise in essential medicines wholesaling.     

How to establish a successful revolving drug fund: the experience of Khartoum state in the Sudan

Problem

During the 1990s, the Sudan began several initiatives to establish new medicine-financing mechanisms as part of the health reform process. Initial seed stocks were provided to each hospital. Unfortunately these facility-based funds did not regenerate and the hospitals were left without funds for medicines. The Revolving Drug Fund (RDF) was established in 1989 to facilitate access to medicines in health facilities in Khartoum state.

Approach

This study used quantitative and qualitative research techniques to collect data from health-care providers and users to evaluate the experience of operating an RDF in Khartoum state. Data from personal observations and from archival and statistical records were also analysed. Seven health facilities were sampled for this research.

Local setting

The Ministry of Health has a policy to expand the RDF to the whole country and has already commenced roll-out to seven more states. This policy is based on the experience of the RDF within Khartoum state.

Relevant changes

Khartoum state has a high (97%) level of availability of essential medicines and this is attributed to the RDF. The RDF medicines were mostly considered affordable by users and very few (6%) patients failed to obtain the prescribed medicines for financial reasons.

Lessons learned

The RDF could be successfully replicated in other states of the Sudan and in low-income countries with similar contexts on condition that they meet success factors, such as gradual implementation, political commitment and availability of hard currency.     

Medicines information provided by pharmaceutical representatives: a comparative study in Australia and Malaysia

Background  

Pharmaceutical representatives provide medicines information on their promoted products to doctors. However, studies have shown that the quality of this information is often low. No study has assessed the medicines information provided by pharmaceutical representatives to doctors in Malaysia and no recent evidence in Australia is present. We aimed to compare the provision of medicines information by pharmaceutical representatives to doctors in Australia and Malaysia.     

Patient organisations and the reimbursement process for medicines: an exploratory study in eight European countries

Background  

Little is known about the role European patient organisations play in the process of deciding on reimbursement for medicines. Therefore we explore the current role of patient organisations in the process of reimbursement for medicines in Western Europe. We focus in particular on collaboration between patient organisations and the pharmaceutical industry in this respect.     

A new entity for the negotiation of public procurement prices for patented medicines in Mexico

Problem

As countries expand health insurance coverage, their expenditures on medicines increase. To address this problem, WHO has recommended that every country draw up a list of essential medicines. Although most medicines on the list are generics, in many countries patented medicines represent a substantial portion of pharmaceutical expenditure.

Approach

To help control expenditure on patented medicines, in 2008 the Mexican Government created the Coordinating Commission for Negotiating the Price of Medicines and other Health Inputs (CCPNM), whose role, as the name suggests, is to enter into price negotiations with drug manufacturers for patented drugs on Mexico’s list of essential medicines.

Local setting

Mexico’s public expenditure on pharmaceuticals has increased substantially in the past decade owing to government efforts to achieve universal health-care coverage through Seguro Popular, an insurance programme introduced in 2004 that guarantees access to a comprehensive package of health services and medicines.

Relevant changes

Since 2008, the CCPNM has improved procurement practices in Mexico’s public health institutions and has achieved significant price reductions resulting in substantial savings in public pharmaceutical expenditure.

Lessons learnt

The CCPNM has successfully changed the landscape of price negotiation for patented medicines in Mexico. However, it is also facing challenges, including a lack of explicit indicators to assess CCPNM performance; a shortage of permanent staff with sufficient technical expertise; poor coordination among institutions in preparing background materials for the annual negotiation process in a timely manner; insufficient communication among committees and institutions; and a lack of political support to ensure the sustainability of the CCPNM.     

Factors influencing the utilization of research findings by health policy-makers in a developing country: the selection of Mali's essential medicines

Background  

Research findings are increasingly being recognized as an important input in the formation of health policy. There is concern that research findings are not being utilized by health policy-makers to the extent that they could be. The factors influencing the utilization of various types of research by health policy-makers are beginning to emerge in the literature, however there is still little known about these factors in developing countries. The object of this study was to explore these factors by examining the policy-making process for a pharmaceutical policy common in developing countries; an essential medicines list.     

Medicines coverage and community-based health insurance in low-income countries

Objectives  

The 2004 International Conference on Improving Use of Medicines recommended that emerging and expanding health insurances in low-income countries focus on improving access to and use of medicines. In recent years, Community-based Health Insurance (CHI) schemes have multiplied, with mounting evidence of their positive effects on financial protection and resource mobilization for healthcare in poor settings. Using literature review and qualitative interviews, this paper investigates whether and how CHI expands access to medicines in low-income countries.     

Expiry of medicines in supply outlets in Uganda

Problem

The expiry of medicines in the supply chain is a serious threat to the already constrained access to medicines in developing countries.

Approach

We investigated the extent of, and the main contributing factors to, expiry of medicines in medicine supply outlets in Kampala and Entebbe, Uganda. A cross-sectional survey of six public and 32 private medicine outlets was done using semi-structured questionnaires.

Local setting

The study area has 19 public medicine outlets (three non-profit wholesalers, 16 hospital stores/pharmacies), 123 private wholesale pharmacies and 173 retail pharmacies, equivalent to about 70% of the country’s pharmaceutical businesses. Our findings indicate that medicines prone to expiry include those used for vertical programmes, donated medicines and those with a slow turnover.

Relevant changes

Awareness about the threat of expiry of medicines to the delivery of health services has increased. We have adapted training modules to emphasize management of medicine expiry for pharmacy students, pharmacists and other persons handling medicines. Our work has also generated more research interest on medicine expiry in Uganda.

Lessons learned

Even essential medicines expire in the supply chain in Uganda. Sound coordination is needed between public medicine wholesalers and their clients to harmonize procurement and consumption as well as with vertical programmes to prevent duplicate procurement. Additionally, national medicine regulatory authorities should enforce existing international guidelines to prevent dumping of donated medicine. Medicine selection and quantification should be matched with consumer tastes and prescribing habits. Lean supply and stock rotation should be considered.     

A descriptive review of the methodologies used in household surveys on medicine utilization

Background  

Studies carried out in the community enable researchers to understand access to medicines, affordability, and barriers to use from the consumer's point of view, and may stimulate the development of adequate medicines policies. The aim of the present article was to describe methodological and analytical aspects of quantitative studies on medicine utilization carried out at the household level.     

Consumer involvement in Quality Use of Medicines (QUM) projects – lessons from Australia

Background  

It is essential that knowledge gained through health services research is collated and made available for evaluation, for policy purposes and to enable collaboration between people working in similar areas (capacity building). The Australian Quality Use of Medicine (QUM) on-line, web-based project database, known as the QUMmap, was designed to meet these needs for a specific sub-section of health services research related to improving the use of medicines. Australia's National Strategy for Quality Use of Medicines identifies the primacy of consumers as a major principle for quality use of medicines, and aims to support consumer led research. The aim of this study was to determine how consumers as a group have been represented in QUM projects in Australia. A secondary aim was to investigate how the projects with consumer involvement fit into Australia's QUM policy framework.     

TRIPS, the Doha declaration and paragraph 6 decision: what are the remaining steps for protecting access to medicines?

Background  

The World Trade Organisation's Declaration on the TRIPS Agreement and Public Health (known as the Doha Declaration) of 2001, and subsequent Decision on the Interpretation of Paragraph 6 reached in 2003, affirmed the flexibilities available under the Agreement on Trade Related Property Rights (TRIPS) to member states seeking to protect public health. Despite these important clarifications, the actual implementation of these measures to improve access to medicines remains uncertain. There are also concerns that so-called TRIPS-plus measures within many regional and bilateral trade agreements are further undermining the capacity of the poor to access affordable medicines.     

Health-related quality of life,and its determinants,among older people in rural Vietnam

Background  

The proportion of people in Vietnam aged 60 and above has increased rapidly in recent decades. However, there is a lack of evidence, particularly in rural settings, on their health-related quality of life (HRQoL) within the context of socioeconomic changes and health-sector reform in the country. This study assesses the level and determinants of HRQoL in a rural district in order to provide evidence for designing and implementing appropriate health policies.     

Does the development of new medicinal products in the European Union address global and regional health concerns?

Background  

Since 1995, approval for many new medicinal products has been obtained through a centralized procedure in the European Union. In recent years, the use of summary measures of population health has become widespread. We investigated whether efforts to develop innovative medicines are focusing on the most relevant conditions from a global public health perspective.     

Urban health insurance reform and coverage in China using data from National Health Services Surveys in 1998 and 2003

Background  

In 1997 there was a major reform of the government run urban health insurance system in China. The principal aims of the reform were to widen coverage of health insurance for the urban employed and contain medical costs. Following this reform there has been a transition from the dual system of the Government Insurance Scheme (GIS) and Labour Insurance Scheme (LIS) to the new Urban Employee Basic Health Insurance Scheme (BHIS).     

Smoking-attributable mortality and years of potential life lost in 16 Brazilian capitals, 2003: a prevalence-based study

Background  

To establish the impact of tobacco smoking on mortality is essential to define and monitor public health interventions in developing countries.     

Conceptual framework of public health surveillance and action and its application in health sector reform

Background  

Because both public health surveillance and action are crucial, the authors initiated meetings at regional and national levels to assess and reform surveillance and action systems. These meetings emphasized improved epidemic preparedness, epidemic response, and highlighted standardized assessment and reform.     

The role of discounts and loss leaders in medicine procurement in Austrian hospitals - a primary survey of official and actual medicine prices

Background

Knowledge about the prices of medicines used in hospitals, particularly the actually achieved ones, is scant. There are indications of large discounts and the provision of medicines cost-free to Austrian hospitals. The study aims to survey the official and actual prices of medicines procured by Austrian hospitals and to compare them to the out-patient prices.

Methods

Primary price collection of the official hospital list prices and the actually achieved prices for 12 active ingredients as of the end of September 2009 in five general hospitals in Austria and analysis of the 15 most commonly used presentations.

Results

The official hospital list prices per unit differed considerably (from 1,500 Euro for an oncology medicine to 0.20 Euro for a generic cardiovascular medicine). For eight on-patent medicines (indications: oncology, anti-inflammatory, neurology-multiple sclerosis and blood) actual hospital medicine prices equaled the list prices (seven medicines) or were lower (one medicine) in four hospitals, whereas one hospital always reported higher actual prices due to the application of a wholesale mark-up. The actual hospital prices of seven medicines (cardiology and immunomodulation) were below the official hospital prices in all hospitals; of these all cardiovascular medicines were provided free-of-charge. Hospital prices were always lower than out-patient prices (pharmacy retail price net and reimbursement price).

Conclusion

The results suggest little headroom for hospitals to negotiate price reductions for “monopoly products”, i.e. medicines with no therapeutic alternative. Discounts and cost-free provision (loss leaders) appear to be granted for products of strategic importance for suppliers, e.g. cardiovascular medicines, whose treatment tends to be continued in primary care after discharge of the patient.

     

Canada's Patented Medicine Notice of Compliance regulations: balancing the scales or tipping them?

Background  

In order to comply with the provisions of the North American Free Trade Agreement, in 1993 the Canadian federal government introduced the Patented Medicine Notice of Compliance Linkage Regulations. These regulations were meant to achieve a balance between the timely entry of generic medicines and the rights of patent holders. The regulations tied the regulatory approval of generic medicines to the patent status of the original brand-name product.     

A retrospective analysis of health systems in Denmark and Kaiser Permanente

Background  

To inform Danish health care reform efforts, we compared health care system inputs and performance and assessed the usefulness of these comparisons for informing policy.