Essential Laws for Medicines Access

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Essential laws for Medicines Access

Essential Laws for Medicines Access: A Study on National Legislation

Report to the WHO-EMP Department on work undertaken in Geneva, June-August 2010

Professor Michele Forzley, JD, MPH

Widener University School of Law

David Michael Walker, BSED

Widener University School of Law

Juris Doctor Candidate 2011

Marie Elske Gispen, LL.B.

Utrecht University

LL.M. expected 2011

Acknowledgments

This paper is the report on the study on national laws in support of essential medicines access undertaken in Geneva, June-August 2010 in the WHO-EMP Department. This work was conceived and conducted under the supervision of Professor Michele Forzley with two students David Walker and Marie Elske Gispen. Carly Gardner, also a Widener Law student, contributed to the drafting and editing process of this study. This established work informed the hypothesis of this work and was the source of a substantial portion of the data used. In particular the authors would like to acknowledge Hans Hogerzeil, Director of the Department of Essential Medicines at WHO for his enlightened view of wide variety of factors that support medicines access and thus his openness to the design and conduct of the study. This academic freedom was and will remain critical to the long-term potential of this work. We thank Dr. Hogerzeil for his guidance. This acknowledgement would not be complete without also thanking Richard Laing for his contribution of time, insights and critical thinking. Finally the authors thank the Widener School of Law Health Law Institute and Dean Linda Ammons for supporting the global extern program from its inception in 2010 and its continual development.

Table of Contents

Executive Summary...... 4

1. Introduction...... 6

2. Study Design...... 8

3. Results...... 15

4. Discussion...... 20

5. Conclusions...... 23

6. Recommendations by Student Researchers...... 26

Annexes...... 28

1. Selection Data

Annex 1.1.: Full set of Member State Selection Data...... 28

Annex 1.2.: Selection Data of Member States Analysed...... 30

1. Country Profiles
2. Australia...... 31
3. The Netherlands...... 37
4. South Africa...... 43
5. Tonga...... 49

1. Comparative Charts

Annex 3.1.: ICESCR...... 55

Annex 3.2.: Government Commitment...... 56

Annex 3.3.: Sustainable Financing...... 57

Annex 3.4.: Rational Selection...... 58

Annex 3.5.: Affordable Pricing...... 59

Annex 3.6.: Country Selection Total Scores ……………………61

References...... 62

Executive Summary

1. In countries with high scores on medicines access there appears to be a comprehensive, integrated and coordinated body of laws that support medicines access. Moreover in these countries government commitment is strong and reflected in all aspects of the body of law. This government commitment can be independent of a constitutional right to medicines or health. However, in these countries the laws on medicines access are found in legislation and not administrative regulation.
2. The laws place the government in the position of the actor responsible for taking actions to ensure medicines access as compared to the patient having a right to receive.
3. No country had a legal mandate to create or maintain an essential medicines list. Given the importance of this list to the reimbursement list, drug registration and procurement, this legal gap can be immediately remedied.
4. Access indicators at present do not adequately reflect legal aspects of medicines access. Work should be done to improve indicators of ELMA.

1. Introduction

The right to health (RtH) is one of the set of fundamental, interdependent human rights, anchored in several international, regional and national legal documents.[1] No government can deliver the means and mechanisms that ensure the realization of the right to health unless it also delivers access to essential medicines. Essential medicines (EM) are those medicines that satisfy the majority of health care needs of a population.[2] If the RtH is to be satisfied, then EM must be available in appropriate amounts, at all times, of good quality, and at affordable prices.[3] Currently lack of access, waste, poor quality and irrational use characterize the state of access to EM for much of the world’s population.[4] Thus, a major focus of the WHO and multiple public and private international and national organizations is achieving and improving medicines access. Even with adequately funded health systems, access to medicines can be compromised by a number of factors such as corruption, poor inventory management and procurement failure.

In this study the focus is on the legal dimensions of medicines access beyond those found in human rights law. The WHO has published some significant works on the regulation of pharmaceuticals in developing countries from a legal or legislative perspective, most notably that of D.C. Jayasuriya in 1985.[5] That guide describes some of the possible approaches to the establishment of a regulatory framework, focusing mainly on the establishment of systems to ensure the availability of safe and effective medicines of good quality at reasonable prices. Its audience is policy makers and administrators who are not lawyers. Following good practices of its time, it encompasses topics including institutional mechanisms, importation, manufacturing, exporting, sale and distribution, labelling, advertising, clinical trials, quality control, and the certification scheme on products moving in international commerce.

Establishing a regulatory framework around the functional aspects of a pharmaceutical supply system is essential – and is an intuitively logical approach. Clearly, without good quality medicines in the system there can be no access. Earlier works have attempted to define the basic elements of medicines legislation through the use of the consultation process, such as the 1981 study by the Action Program on Essential Drugs.[6] This consultation resulted in the Jayasuriya book that bases its suggestions on legislation according to the functional elements of the pharmaceutical supply system. There have also been guides to drug policy with limited content on legislation, including the second edition in 2001 of How to Develop and Implement a National Drug Policy.[7]

Absent from the literature is an evidence-based guide that builds on work to date and considers all other sectors of the national system that contribute to medicines access, such as tariffs and their waivers, the justiciability of the right to health, and limitations on supply chain margins among others. In this study, a method was designed to study and systematically identify the laws in countries where citizens enjoy the right to medicines and access with a long term goal to build an evidence base on which legislative best practices can be articulated. Given the breadth of subjects to be comprehensively covered, this pilot study showcases a very narrow exploration based on the new progress indicators established in the WHO Medicines Strategy for 2008-2013.

The methodology of this study is based on our hypothesis that in countries in which citizens enjoy access, the rule of law is also well established. In this context, we refer to the rule of law as defined by four parameters: government accountability; fair processes; access to justice; and for our purpose, laws that are clear, publicized, stable and fair, and that protect fundamental rights. Thus, there will be a body of law relevant to the means and mechanisms by which access is accomplished, and this body of law will function without regard to and independently of human rights legislation in a country. The opposite should also be true – where there is no rule of law, there will be decreased access, and it follows that to achieve access there must be a minimum body of law. The aim of this survey is to understand the requisite elements based on the evidence of what laws are in effect in countries with access.

From this evidence good legislative elements and model texts can be defined and a set of legal indicators on access can be crafted. Moreover, these legislative tools and the assessment process of this study serve country stakeholders – including lawyers, legislators, civil society and regulators – to establish a strong legal foundation for medicines access.

1. Study Design

2.1 Methodology – Overview

A scoring method was developed that credited a value to a set of widely published and accepted indicators of medicines access, rule of law and development. The methodological approach is based on the concept of translating knowledge into health decision-making and action.[8] This approach begins with the notion that data by itself is worth nothing. However, once data is combined with other data, such as was done with the WHO progress indicators, an understanding can be established, which will lead to knowledge and, consequently, proper action.

The highest scoring countries were then investigated to find those with national laws in English and digital format easily retrieved via on-line libraries and databases. The national laws of each country were researched and a comparative analysis prepared. These laws are the data of this study and are referred to as “legal information.” In addition, a country profile was prepared to describe the overall structure of each government and health system. Four countries were selected for study during the pilot phase. The full data set does not include all 193 WHO Members as not all Members report data on access to medicines and do not do so for various reasons not relevant here.

2.1.1. Country Selection

A. Indicators and Scoring

The WHO progress indicators and targets, the Human Development Index and the Rule of Law Index were selected for scoring each country. There is readily available data and widespread reporting across all WHO regions and member states on these indicators. Moreover, these indicators are widely adopted for their specificity. Each is described in more detail subsequently.

WHO Progress Indicators and targets: The report Implementing the third World Medicines Strategy 2008-2013 describes progress indicators and targets. Data on these is collected by countries and the WHO as part of the WHO Medium-Term Strategic Plan for 2008-2013. These indicators represent five aspects of access – government commitment, rational selection, affordable prices, sustainable financing, and reliable systems – and are widely believe to represent how serious a government is in making essential medicines available to all.[9] Some of these indicators lend themselves readily to the formation of a legal inquiry, such as whether legal provisions exist that allow and/or encourage generic substitution. Others require some adjustment, such as whether there is an updated national list of essential medicines. The legal query for this indicator had to be adjusted to search for any provision in the law relevant to a national list of essential medicines.

Data on progress indicators were available for the following dimensions, although not all countries reported on all of these.[10]

• Access to essential medicines/technologies as part of the fulfilment of the right to health, recognized in the constitution.
• Existence of a published national medicines policy that has been updated within the last 10 years.
• Existence of a published national list of essential medicines that has been updated within the last 2 years.
• Legal provisions to allow/encourage generic substitution in the private sector
• Median consumer price ratio of 30 selected essential medicines in public and private health facilities is below four times the world market reference price.
• Public/Private per capita expenditure on medicines as a country specific value.
• The average availability of 30 selected essential medicines in public and private health facilities meets a target value of 80%.

Since one of the indicators is the recognition (or lack) of the right to medicines in the constitution of a country a study done by the Katrina Perehudoff was extremely useful to make this determination and was the main source of this legal information.[11]

The Human Development Index: The Human Development Index (HDI) measures development by combining indicators of life expectancy, educational attainment and income into a composite human development index. The HDI is a single statistic or snapshot of both social and economic development.[12] The selection of HDI as an indicator relevant to medicines access assumes that countries with a higher HDI are more likely to have national policies, including laws and regulations that protect the right to health and provide access to essential medicines.

The World Justice Project Rule of Law Index:[13] The Rule of Law Index measures the extent to which states adhere to the rule of law on a scale of 0.0 to 1.0. The Index evaluates how nations apply their laws in practice according to the four main elements of the rule of law (Figure 1). As noted earlier, Element 2 is highly relevant to our hypothesis and question; which laws are present in the countries in which citizens enjoy access to medicines? Element 2 looks to the status of laws – are they clear, publicized, stable and fair, and do they protect fundamental rights?

B. Scoring and Interpretation of Data

Once data for the indicators noted above were gathered, country results were scored according to a point system and then ranked by score, highest to lowest. The following shows how each indicator was scored.

Box 2 contains an example to illustrate a country score.

For the indicator of public/private per capita expenditure on medicines, if a Member State reported public expenditure on medicines equal to or greater than that of private expenditure then that Member State earned one point. However, if a Member State reported public expenditure on medicines that amounted to 70% or more of the total expenditure on medicines, then that State earned two points. The reasoning for the awarding of this extra point rests on the assumption that increased public financing of medicines amounts to a greater government commitment to access to medicines.

Each of the remaining indicators listed herein can be simply answered “yes” or “no.” If a Member State satisfied an indicator, earning a “yes,” then that State also earned a point. Likewise, if a Member State did not satisfy an indicator, or no data was reported on an indicator, then that State received a “no” and did not earn a point for that particular indicator.

On HDI a rank in the “high” category earned one point and a ‘very high' category earned two points. For both sub-factors of the rule of law index, if the score was greater than .45, one point was allocated. If the score was below .45, the country received no points. The level of .45 was selected so as to include a large number of countries, as a number too high would exclude too many countries.

1. Final Selections

In order to start with a diverse group of countries, three other screens were applied to make a final selection – the World Bank income levels;[14] the WHO region;[15] and the WHO Country rankings based on the World Health Report 2000.[16] Once the Member States were scored and ranked according to the system set out above, an effort was made to select Member States from a variety of WHO regions, as well as World Bank income levels. If multiple Member States received identical scores from the indicator data discussed above, as well as were from the same WHO region and had the same World Bank income level, then the Member State with the highest overall ranking was selected. The final determinative factor in selecting Member States for inclusion in this pilot study was the availability of their laws in English, and on-line or other readily available format. The cost of access factor was managed by the use of free on-line sources and the in-kind contribution of Widener University School of Law library services available to the researchers from the institution. Accordingly, one lower-middle, one upper middle and two high-income countries were selected from the EURO, AFRO and WPRO regions. Ultimately all countries should be analysed. It was our view that by picking an array to start would provide an opportunity to test the methodology and possibly provide information for further refinements. The following chart displays study and rule of law scores and income levels. A chart of countries listed in alphabetical order is at annex 1.3.