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WHO_Essential_Medicines_List_from_Idea_to_Implementation_FINAL.pdf

The document discusses the World Health Organization's Essential Medicines List, including its origins, purpose, and implementation. The WHO created the list to improve access to important medicines in developing countries by identifying medicines that address priority health needs. Medicines are added based on criteria like efficacy, safety, and cost-effectiveness. However, fully implementing the list in developing nations faces barriers such as inadequate infrastructure for storage and distribution of medicines, social inequalities, and intellectual property restrictions.

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World Health Organization’s Essential Medicines List: From Idea to Implementation Brian M. Kaiser Pharm.D. Pharmacy Practice Resident University of California, San Francisco Prepared as part of an education project of the Global Health Education Consortium and collaborating partners
Page 2 Objectives • Analyze the rationale for the creation of the World Health Organization (WHO) Essential Medicines List. • Identify how and why a medication is added to the WHO Essential Medicines List. • Assess the current utility of the WHO Essential Medicines List in developing countries. • Describe the barriers to implementation of the WHO Essential Medicines List in developing countries. Page 2 At the end of this presentation, the reader will be able to…
Page 3 WHO Definition of Health • WHO Constitution states: “Health is a state of complete physical, mental and social well-being and not merely an absence of disease or infirmity.” • Definition of health reaffirmed in the Alma-Ata Declaration (1978) and specifically stated: – Primary health includes: at least…provision of essential drugs WHO Constitution Basic Documents 45th Ed 2006 International Conf Primary Health Care Alma-Ata USSR 1978 Page 3
Page 4 Medicines http://www.indopia.in/resources/images/original/medicines.jpg Page 4
Page 5 Defining Essential Medicines • Original definition (1977) “of utmost importance, basic, indispensable, and necessary for the healthcare needs of the population” • Current definition (2002) “Essential medicines are those that satisfy the priority health care needs of the population” http://www.who.int/topics/essential_medicines/en/ Page 5
Page 6 Notes on Defining Essential Medicines. The full definition of essential medicines is given below. The main point of this definition is to reinforce that the list is not a permanent list of must have medicines but rather a guide. Each country must determine its own list based on the current and future public health needs, and availability of medicines. Essential medicines are those that satisfy the priority health care needs of the population. They are selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost- effectiveness. Essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford. The implementation of the concept of essential medicines is intended to be flexible and adaptable to many different situations; exactly which medicines are regarded as essential remains a national responsibility
Page 7 History of Essential Medicines • 1975 World Health Assembly (WHA) meeting, report by WHO Director-General regarding problems facing countries in area of medicines, first mention of essential medicines • 1977 first Expert Committee on essential medicines issues technical report and compilation of essential medicines • 1978 Resolution WHA 31.32 passed urging members to establish national essential medicine lists • 1978 Alma-Ata Declaration on primary care issued Page 7
Page 8 Handbook on Essential Drugs Page 8
Page 9 What is the “List”? • There are 2 components – Core list is the minimum for a basic health care system – Complementary list covers priority diseases that require special facilities, equipment, and/or training • Divided into therapeutic categories Page 9
Page 10 Core List Medicines • Treat priority conditions – current or future public health issues with potential for safe and cost- effective treatment Based upon: – Efficacy – Safety – Cost-effectiveness WHO Model List of Essential Medicines 15th List March 2007 Page 10
Page 11 Complementary List Medicines • Treat a priority condition • Require special: – Diagnostic or monitoring facilities – Medical care – Training • Consistently higher cost or minimal cost- effectiveness WHO Model List of Essential Medicines 15th List March 2007 Page 11
Page 12 Therapeutic Equivalence • Similar clinical performance within a pharmacological class • Listed medicine should be an example of the therapeutic class – May have best evidence for efficacy and safety – May be first licensed compound – When no difference in efficacy or safety between agents, may be least expensive option WHO Model List of Essential Medicines 15th List March 2007 Page 12 Therapeutic equivalence indicates that medicines have similar clinical efficacy, though there may be some benefits of one medicine over another based on dosing frequency or side effect profile. In the U.S. the most common example of drugs with therapeutic equivalence are the HMG-CoA Reductase Inhibitors or “Statins” (e.g. Rosuvastatin, atorvastatin, simvastatin, lovastatin, pravastatin)
Page 13 Example 1.2 Local anesthetics □ bupivacaine Injection: 0.25%; 0.5% (HCl) in vial ephedrine Injection: 30mg (HCl)/mL in 1-mL ampule (Spinal anesthesia during delivery, prevent hypotension) Indicates multiple Therapeutic Equivalent agents (e.g. Ropivacaine, Mepivacaine, Levobupivacaine) Core Medicine Complementary Medicine WHO Model List of Essential Medicines 15th List March 2007 Page 13
Page 14 Updating the List • Updated every 2 years by expert committee • New medicines or updates are submitted via application • Expert committee reviews applications and available data and recommend medicines to add http://www.who.int/topics/essential_medicines/en/ Page 14
Page 15 Medicine Applications: Additions, Updates or Deletions • Application submitted or supported by a WHO group • Organizations consulted and/or supporting the application • Public health relevance of drug • Includes comparative efficacy, safety and cost- effectiveness • International availability (manufacturers) • Regulatory status (in country of origin and abroad) • Availability of pharmacopoeia standards (USP) http://www.who.int/selection_medicines/committees/AppForm.pdf Page 15
Page 16 Medicines Page 16
Page 17 Reasons For the List • Portion of health dollars spent on pharmaceuticals – Developed countries 20% – Transitional countries 15-30% – Developing countries 25-66% • Pharmaceuticals are largest public expenditure on health after personnel costs in low income countries http://www.who.int/topics/essential_medicines/en/ Page 17
Page 18 Medicine Affordability Comparison of household income to percentage of medicines obtained. WHO Medicines Strategy- Countries at the Core 2004-2007 Conclusion: In countries with income <$2/day, more patients go without some or all of their medicines compared to those with income >$10/day Page 18
Page 19 More Reasons For The List • Lack of access to essential medicines • Irrational use of available medicines • Poor drug quality of available medicines Page 19
Page 20 Limited Medication Availability in the Developing World Percentage of essential medicines available for use in specified countries in public and private healthcare facilities. Medicines are not readily available for use irrespective of patient ability to purchase WHO Medicines Strategy- Countries at the Core 2004-2007 Page 20
Page 21 Benefits • Evidence-based rationale for the appropriate use of medicines • Cost justification for purchasing decisions • Allows for individualization to a country’s public health needs Page 21
Page 22 How the List is Used: Country-Specific Formulary • Can be implemented on a Country, Provincial or Institutional Level • Customizable – To clinical guidelines for health care practice – To region-specific public health issues – To least costly or most accessible therapeutic equivalent Page 22
Page 23 Country-Specific (continued) • In 2008 – 156 of 193 WHO member states have official Essential Medicines Lists – 127 of 156 have updated lists in the past 5-10 years – Some have State and/or Provincial lists http://www.who.int/topics/essential_medicines/en/ Page 23
Page 24 Countries with Essential Medicines Lists, 2002 WHO Policy Perspectives on Medicines No. 04 June 2002 Page 24
Page 25 How the List is Used: International Governmental Organizations • United Nations Children’s Fund (UNICEF) • United Nations High Commission for Refugees (UNHCR) • Guides: – Procurement – Reimbursement – Donations Page 25
Page 26 How the List is Used: Non- Governmental Organizations (NGOs) • International Federation of the Red Cross and Red Crescent Societies • Médecins Sans Frontières (MSF)/ Doctors without Borders) • Oxfam • These groups’ medicines policies are based on the Essential Medicines List concept Page 26
Page 27 How the List is Used: Special Indications • UN List of Emergency Relief Items • Essential Medicines for Reproductive Health • Children’s Essential Medicines • Interagency Emergency Health Kit Page 27 These lists have been instituted to supplement the full essential medicines list for specific indications. There is now a full children’s essential medicines list that specifically incorporates pediatric dosage forms (e.g. suspensions, chewable tablets, disintegrating tablets). This list was first published in 2007 and is separate from the essential medicines list. The Emergency Kits are designed to provide medicines that would be effective and needed in any form of emergency (e.g. war, natural disaster, humanitarian crisis). MSF/Doctors without Borders also uses this concept in its emergency kits.
Page 28 Practical Applications Of The List • Essential Medicines List is implemented at the governmental level, but there are barriers • Barriers – Infrastructure inadequacies (warehousing, distribution system, cold chain maintenance) – Social Inequalities/Poverty – Regulatory authorities, constraints – Intellectual Property Rights (patent protection) – Opposition of medical and pharmaceutical associations Page 28
Page 29 Barriers: Infrastructure A Tractor Trailer truck Driving along Highway 1 In Niger, West Africa Page 29
Page 30 Barriers: Infrastructure • Distribution of medicines to clinics, especially rural areas – Lack of roadways, adequate transportation vehicles, cold- chain • Inadequate number and training of healthcare workers • Limited or no access to clean water or sanitation facilities The world health report 2006 – Working together for health. Geneva, WHO Page 30 These infrastructure barriers have become a recurring theme when discussing healthcare in the developing world and are closely intertwined with poverty both at the national and individual level. A thorough discussion of these factors is outside of the scope of this learning module, but should be understood as significant barriers to implementing the essential medicines concept.
Page 31 World Distribution of Health Care Workers Health care workers include people who provide health services, management, and support workers (e.g. cooks, driver, cleaners etc.) The world health report 2006 – Working together for health. Geneva, WHO Page 31
Page 32 Barriers: Social Inequalities and Poverty • Inability to afford medicines, both individuals and nations • Inadequate amounts of clean water or sanitation facilities • Gender inequality • Class discrimination • Access to the healthcare system Dying for Change Geneva WHO, World Bank 2002 Page 32
Page 33 Barriers: Regulatory • Ability of a nation to regulate medicines including: – Good Manufacturing Practices (GMP) – Review of clinical trial data for safety, efficacy ± cost- effectiveness • Or, ability of nation to produce medicines: – Manufacturing infrastructure, GMP – Obtain, interpret safety and efficacy data Page 33 The regulation of medicines by the government ensures the safety and efficacy of drug products. This regulation requires significant investment by the government to review clinical trial data, ensure appropriate manufacturing practices and maintain the safety of the drug supply. The human capital required to accomplish these task is a barrier in many developing countries with relatively small budgets.
Page 34 Barriers: Intellectual Property Rights • World Trade Organization (WTO) Agreement on Trade- Related Aspects of Intellectual Property Rights (TRIPS) – Requires all countries to respect current patents and establish ways to protect those patents, especially for brand name pharmaceuticals – All medicine purchasers have to pay the price negotiated with the patent holder for the branded medicine, no generics can be made or purchased – But, the WTO agreed to a “Public Health Emergency Clause”… Agreement on Trade-Related Aspects of Intellectual Property Rights, Geneva, World Trade Organization 1994 Page 34
Page 35 TRIPS (continued) • In the event of a public health crisis, countries may issue “compulsory licenses” for medicines • Allows medicines to be produced or imported without regard to patent law • However…... – What constitutes a “public health crisis”? – In a country with infrastructure problems, how can they produce medicines? – If patents are respected worldwide, where can a country find generic medicines? Page 35
Page 36 A full review of international intellectual property rights regulation is outside of the scope of this learning module. Please see the module dedicated to this topic on the GHEC website. A basic overview follows. 1. TRIPS- Multilateral (e.g. between multiple countries, in this case all WTO countries) trade agreement that extends patent protection to intellectual property including pharmaceuticals. Established time frame for all countries to be in compliance with the regulations. Contained a public health crisis clause that would allow a country to issue a compulsory license for a pharmaceutical; effectively allowing a patented medicine to be produced or imported as a generic with a small fee paid to the patent holder. Only allowed if the country issuing the compulsory license is unable to reach an agreement with the patent holder. 2. Doha Declaration- Allowed for countries to determine their own public health crisis. Reinforced the legality of issuing compulsory licenses. 3. TRIPS-PLUS- Bilateral (e.g. between two countries, usually the United States and a developing country) trade agreement that removes the public health crisis clause. TRIPS (continued
Page 37 Compulsory Licenses Explained, Sort of…The Doha Declaration • The Doha Declaration on Primary Health Care (2001) reiterated the concept of access to essential medicines • Determines that “public health crisis” should be interpreted based on each country’s needs • Compulsory licenses can be issued for any medicine that would satisfy those needs • Problem presumably “solved”… Doha Ministerial Declaration, Geneva World Trade Organization 2001 Page 37
Page 38 Consequences of Doha Declaration • Most countries can still not afford to produce their own medicines, but generics can now be imported (e.g., from India, Brazil) • Countries that have issued compulsory licenses have faced sanctions from the developed world (e.g., South Africa issued licenses for some anti-retrovirals to treat HIV/AIDS in the 1990s and faced sanctions from the United States) Page 38
Page 39 Consequences (continued) • Bilateral Trade Agreements (between two countries only) • Known as TRIPS Plus, agreements are usually between the U.S. and a developing country • Agreements specifically exclude the public health crisis and compulsory licenses provision • Overrides the original WTO TRIPS agreement Page 39
Page 40 Notes on Consequences. Bilateral trade agreements are usually between a developed country (e.g. the United States, European Union countries etc.) and a developing country. These agreements are generally stricter than the TRIPS agreement, especially in the ability of developing countries to issue compulsory licenses. For example, the U.S. may enter into an agreement with a developing country that offers that country a more favorable trade relationship. In return, the developing country agrees to more stringent patent protection on goods from the U.S. The developing country may no longer be able to issue a compulsory license on a medication from a U.S. pharmaceutical manufacturer. But, these bilateral agreements, being only between two countries, do no effect the developing countries ability to issue a compulsory license on a medicine produced by a E.U. pharmaceutical company, (assuming there are no other bilateral trade agreements in effect) TRIPS would still apply in that relationship.
Page 41 Opposition from Medical and Pharmaceutical Associations • Some policies focused on rationale use of medicines through clinical guidelines, believed to limit clinician judgment or choice (opposed by medical associations) • Some focused on promoting country specific pharmaceutical companies, limiting access to other medicines (opposed by pharmaceutical companies) • Some limited to only generic medicines (opposed by both medical and pharmaceutical associations) Page 41
Page 42 Take Home Points… • Essential Medicines are an indispensible component of a healthcare system • WHO provides an Essential Medicines List that may be used as a framework for developing a national, regional or NGO formulary • The WHO list is updated biannually by expert committee and takes into account new medicines, efficacy, safety and cost-effectiveness Page 42
Page 43 Take Home Points (continued) • The Essential Medicines concept has been widely adopted in WHO member countries, though widespread access to these medicines is still limited • Numerous barriers to implementing the list still exist, specifically infrastructure development problems and international agreements on intellectual property rights that limit medicine availability • Many of the barriers in implementing essential medicines are similar if not identical to barriers facing widespread health care system development Page 43
Page 44 Case Study: Thailand and Compulsory Licenses Page 44 • Context: Thailand is experiencing an HIV/AIDS epidemic. There are a limited number of anti-retroviral treatment options available. One of the mainstays of treatment at this time is a combination protease inhibitor known as Kaletra ® (lopinavir/ritonavir) produced by Abbott Laboratories. At the time there is no generic available. • Problem: The cost of treatment with Kaletra is more than the Thai government is able to afford. Abbott Laboratories is unable to negotiate a compromise on price with the government. • Solution: The Thai government exercised its legal right to issue a compulsory license to import and produce a version of Kaletra to treat a public health crisis. The government complied with all aspects of TRIPS and the Doha Declaration. • Effects: Abbott Laboratories withdrew all applications for new products to be introduced in Thailand including a heat-stable version of Kaletra. Abbott also ceased shipping all of its pharmaceuticals to Thailand. Thailand was placed on the United States Priority Watch List; a list of nations that have “violated” international treaties on intellectual property. Abbott eventually was able to negotiate with the government on a price comparable with available generics. Thailand has not rescinded the compulsory license. • Analysis: Thailand was within its legal rights to issue a compulsory license for Kaletra after negotiations with Abbott failed to render a compromise. The government also agreed to pay Abbott 0.5% of the proceeds from the license. The repercussions, however, were quick and severe. Thailand lost access to many more medicines than it gained. Thailand also remains on the U.S. Priority Watch List, hindering future trade negotiations with the developed world.
Page 45 Quiz • Now we invite you to take the module quiz and test your recent learning. • This module quiz includes 5 multiple choice questions • Note your answers on a piece a paper and then check them against the correct responses • After completing your quiz, come back for the general references of this module presentation.
Page 46 1. Which of the following is NOT part of the rationale for the creation of the Essential Medicines List? A Medicines are one of the largest expenditures of healthcare dollars in developing countries B Essential medicines are a necessity to the provision of primary health care C Essential medicines help to protect intellectual property rights D Essential medicines correspond with priority health needs 2. A novel antifungal was recently approved in the European Union. It is only available as an intravenous formulation and is minimally more effective than current antifungals. Where would this medicine be added on the Essential Medicines List? A The Core List B The Complementary List C A Therapeutic Equivalent D It would not be added to the list at this time
Page 47 3. The concept of essential medicines has been instituted in most countries throughout the world. Which of the following is NOT a direct benefit of the essential medicines list? A Provided a clinical guideline for the appropriate use of medicines B Increased availability of medicines in healthcare systems C Focused on region specific health public health issuesIncorrect D Guided use to least costly or most widely available medicines 4. Achieving full implementation of the essential medicines list has been derailed by numerous barriers. Which of the following barriers is considered mostly a developed world impediment to the goals of the list? A Intellectual property rights and patent law B Poverty at either a personal or country level C Inadequate numbers of healthcare workers in the developing world D Distribution and cold-chain supply problems
Page 48 5. The TRIPS agreement by the WTO is a major barrier to access medicines in developing countries. Which of the following best describes the current state of thinking regarding TRIPS by most developing countries? A TRIPS agreements are legal documents that must be complied with fully; compulsory licenses are effectively illegal B The multilateral trade agreements do not fully protect intellectual property and must be supplemented by more stringent bilateral agreements C Compulsory licenses may only be issued during significant public health crises and will be limited to the duration of the crisis (e.g. cholera outbreaks D Compulsory licenses can and should be issued to treat public health crises as determined by the developing country but only after negotiations with the patent holder have failed to produce an effective solution
Page 49 And now for the answers to the questions
Page 50 1. Which of the following is NOT part of the rationale for the creation of the Essential Medicines List? A Medicines are one of the largest expenditures of healthcare dollars in developing countries -- Incorrect. -- Medicines account for up to 60% of healthcare dollars spent in developing countries B Essential medicines are a necessity to the provision of primary health care Incorrect. -- Essential medicines are specified in the Alma-Alta Declaration on Health C Essential medicines help to protect intellectual property rights -- Correct. - - Intellectual property rights are considered a barrier to the implementation of essential medicines D Essential medicines correspond with priority health needs -- Incorrect.
Page 51 2. A novel antifungal was recently approved in the European Union. It is only available as an intravenous formulation and is minimally more effective than current antifungals. Where would this medicine be added on the Essential Medicines List? A The Core List -- Incorrect. -- While this medicine may treat a priority condition, it requires special administration (IV) and is only minimally more effective than current treatments B The Complementary List -- Incorrect. -- This may be an appropriate category for the medicine, however without cost-effectiveness or cost-comparison information, the medicine will not be added or reviewed. C A Therapeutic Equivalent -- Incorrect. -- This is a novel new medicine and most likely will not have a therapeutic equivalent D It would not be added to the list at this time -- Correct . -- Without cost information, this medicine will not be reviewed or added to the essential medicines list
Page 52 3. The concept of essential medicines has been instituted in most countries throughout the world. Which of the following is NOT a direct benefit of the essential medicines list? A Provided a clinical guideline for the appropriate use of medicines B Increased availability of medicines in healthcare systems -- Correct. -- This is the overall intention of the list, but the list does not directly increase availability of medicines C Focused on region specific health public health issuesIncorrect D Guided use to least costly or most widely available medicines
Page 53 4. Achieving full implementation of the essential medicines list has been derailed by numerous barriers. Which of the following barriers is considered mostly a developed world impediment to the goals of the list? A Intellectual property rights and patent law -- Correct. -- These laws were propagated by the developed world and pharmaceutical companies to inhibit local production of medicines in the developing world B Poverty at either a personal or country level -- Incorrect. -- While the origins of developing world poverty may be attributable to colonization or imperialism, it is generally not considered that the developed world is imposing poverty on developing countries C Inadequate numbers of healthcare workers in the developing world -- Incorrect. -- Though healthcare workers trained in the developing world are more likely to immigrate to developed countries, this it not due to any developed countries policies. In many developed countries, there are policies regarding training healthcare workers from the developing world, but not allowing them to receive visas or immigration status after completing their training D Distribution and cold-chain supply problems -- Incorrect.
Page 54 5. The TRIPS agreement by the WTO is a major barrier to access medicines in developing countries. Which of the following best describes the current state of thinking regarding TRIPS by most developing countries? A TRIPS agreements are legal documents that must be complied with fully; compulsory licenses are effectively illegal -- Incorrect. -- Most countries recognize the validity of compulsory licenses for public health B The multilateral trade agreements do not fully protect intellectual property and must be supplemented by more stringent bilateral agreements -- Incorrect. -- Developed countries, particularly the United States, have taken this stand point C Compulsory licenses may only be issued during significant public health crises and will be limited to the duration of the crisis (e.g. cholera outbreaks -- Incorrect. -- This is the assumed original intent of the compulsory license clause. These licenses would be issued for a limited duration for diseases that could be effectively cured in the short term; it was not intended for chronic diseases (e.g. HIV/AIDS) D Compulsory licenses can and should be issued to treat public health crises as determined by the developing country but only after negotiations with the patent holder have failed to produce an effective solution -- Correct. -- Most developing countries have taken this approach to maintain current trade relations with the developed world while managing the welfare of their own population
Page 55 Page 55 General References Papers: • Sridhar D, Improving Access to Essential Medicines: How Health Concerns can be Prioritised in the Global Governance System. Public Health Ethics. 2008,1(2):83-88 • Koivusalo M, Mackintosh M. Global Public Action in Health and Pharmaceutical Policies: Politics and Policy Priorities. The Open University February 2009 Web Links: • WHO Essential Medicines http://www.who.int/topics/essential_medicines/en/ Gateway to the WHO program on essential medicines including the Expert Committee, Published Essential Medicines Lists and statistics. • WHO http://www.who.int Entry to the WHO website. Provides access to published reports, statistics and WHO programs. • WTO http://www.wto.org Entry to the World Trade Organization website. Provides access to published reports, statistics and WTO trade agreements.
Page 56 Credits Brian M. Kaiser Pharm.D. Pharmacy Practice Resident University of California, San Francisco
Sponsors The Global Health Education Consortium gratefully acknowledges the support provided for developing these teaching modules from: Margaret Kendrick Blodgett Foundation The Josiah Macy, Jr. Foundation Arnold P. Gold Foundation This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 3.0 United States License.
Supplementary Notes
Slide 5: Defining Essential Medicines The full definition of essential medicines is given below. The main point of this definition is to reinforce that the list is not a permanent list of must have medicines but rather a guide. Each country must determine its own list based on the current and future public health needs, and availability of medicines. Essential medicines are those that satisfy the priority health care needs of the population. They are selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost- effectiveness. Essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford. The implementation of the concept of essential medicines is intended to be flexible and adaptable to many different situations; exactly which medicines are regarded as essential remains a national responsibility. Page 59 to Slide 5
Slide 11: Therapeutic Equivalence Therapeutic equivalence indicates that medicines have similar clinical efficacy, though there may be some benefits of one medicine over another based on dosing frequency or side effect profile. In the U.S. the most common example of drugs with therapeutic equivalence are the HMG-CoA Reductase Inhibitors or “Statins” (e.g. Rosuvastatin, atorvastatin, simvastatin, lovastatin, pravastatin) to Slide 11 Page 60
Slide 26: How the List is Used: Special Indications These lists have been instituted to supplement the full essential medicines list for specific indications. There is now a full children’s essential medicines list that specifically incorporates pediatric dosage forms (e.g. suspensions, chewable tablets, disintegrating tablets). This list was first published in 2007 and is separate from the essential medicines list. The Emergency Kits are designed to provide medicines that would be effective and needed in any form of emergency (e.g. war, natural disaster, humanitarian crisis). MSF/Doctors without Borders also uses this concept in its emergency kits. to Slide 26 Page 61
Slide 29: Barriers: Infrastructure These infrastructure barriers have become a recurring theme when discussing healthcare in the developing world and are closely intertwined with poverty both at the national and individual level. A thorough discussion of these factors is outside of the scope of this learning module, but should be understood as significant barriers to implementing the essential medicines concept. to Slide 29 Page 62
Slide 32: Barriers: Regulatory The regulation of medicines by the government ensures the safety and efficacy of drug products. This regulation requires significant investment by the government to review clinical trial data, ensure appropriate manufacturing practices and maintain the safety of the drug supply. The human capital required to accomplish these task is a barrier in many developing countries with relatively small budgets. to Slide 32 Page 63
Slide 33: Barriers: Intellectual Property Rights Back Page 64 For notes, see Teaching Modules Appendix: http://globalhealtheducation.org/Modules/Teachi ng%20Modules%20Appendix/106.aspx.
Note G: Consequences Bilateral trade agreements are usually between a developed country (e.g. the United States, European Union countries etc.) and a developing country. These agreements are generally stricter than the TRIPS agreement, especially in the ability of developing countries to issue compulsory licenses. For example, the U.S. may enter into an agreement with a developing country that offers that country a more favorable trade relationship. In return, the developing country agrees to more stringent patent protection on goods from the U.S. The developing country may no longer be able to issue a compulsory license on a medication from a U.S. pharmaceutical manufacturer. But, these bilateral agreements, being only between two countries, do no effect the developing countries ability to issue a compulsory license on a medicine produced by a E.U. pharmaceutical company, (assuming there are no other bilateral trade agreements in effect) TRIPS would still apply in that relationship. Back Page 65

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WHO_Essential_Medicines_List_from_Idea_to_Implementation_FINAL.pdf

  • 1.
    World Health Organization’s EssentialMedicines List: From Idea to Implementation Brian M. Kaiser Pharm.D. Pharmacy Practice Resident University of California, San Francisco Prepared as part of an education project of the Global Health Education Consortium and collaborating partners
  • 2.
    Page 2 Objectives • Analyzethe rationale for the creation of the World Health Organization (WHO) Essential Medicines List. • Identify how and why a medication is added to the WHO Essential Medicines List. • Assess the current utility of the WHO Essential Medicines List in developing countries. • Describe the barriers to implementation of the WHO Essential Medicines List in developing countries. Page 2 At the end of this presentation, the reader will be able to…
  • 3.
    Page 3 WHO Definitionof Health • WHO Constitution states: “Health is a state of complete physical, mental and social well-being and not merely an absence of disease or infirmity.” • Definition of health reaffirmed in the Alma-Ata Declaration (1978) and specifically stated: – Primary health includes: at least…provision of essential drugs WHO Constitution Basic Documents 45th Ed 2006 International Conf Primary Health Care Alma-Ata USSR 1978 Page 3
  • 4.
  • 5.
    Page 5 Defining EssentialMedicines • Original definition (1977) “of utmost importance, basic, indispensable, and necessary for the healthcare needs of the population” • Current definition (2002) “Essential medicines are those that satisfy the priority health care needs of the population” http://www.who.int/topics/essential_medicines/en/ Page 5
  • 6.
    Page 6 Notes onDefining Essential Medicines. The full definition of essential medicines is given below. The main point of this definition is to reinforce that the list is not a permanent list of must have medicines but rather a guide. Each country must determine its own list based on the current and future public health needs, and availability of medicines. Essential medicines are those that satisfy the priority health care needs of the population. They are selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost- effectiveness. Essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford. The implementation of the concept of essential medicines is intended to be flexible and adaptable to many different situations; exactly which medicines are regarded as essential remains a national responsibility
  • 7.
    Page 7 History ofEssential Medicines • 1975 World Health Assembly (WHA) meeting, report by WHO Director-General regarding problems facing countries in area of medicines, first mention of essential medicines • 1977 first Expert Committee on essential medicines issues technical report and compilation of essential medicines • 1978 Resolution WHA 31.32 passed urging members to establish national essential medicine lists • 1978 Alma-Ata Declaration on primary care issued Page 7
  • 8.
    Page 8 Handbook onEssential Drugs Page 8
  • 9.
    Page 9 What isthe “List”? • There are 2 components – Core list is the minimum for a basic health care system – Complementary list covers priority diseases that require special facilities, equipment, and/or training • Divided into therapeutic categories Page 9
  • 10.
    Page 10 Core ListMedicines • Treat priority conditions – current or future public health issues with potential for safe and cost- effective treatment Based upon: – Efficacy – Safety – Cost-effectiveness WHO Model List of Essential Medicines 15th List March 2007 Page 10
  • 11.
    Page 11 Complementary ListMedicines • Treat a priority condition • Require special: – Diagnostic or monitoring facilities – Medical care – Training • Consistently higher cost or minimal cost- effectiveness WHO Model List of Essential Medicines 15th List March 2007 Page 11
  • 12.
    Page 12 Therapeutic Equivalence •Similar clinical performance within a pharmacological class • Listed medicine should be an example of the therapeutic class – May have best evidence for efficacy and safety – May be first licensed compound – When no difference in efficacy or safety between agents, may be least expensive option WHO Model List of Essential Medicines 15th List March 2007 Page 12 Therapeutic equivalence indicates that medicines have similar clinical efficacy, though there may be some benefits of one medicine over another based on dosing frequency or side effect profile. In the U.S. the most common example of drugs with therapeutic equivalence are the HMG-CoA Reductase Inhibitors or “Statins” (e.g. Rosuvastatin, atorvastatin, simvastatin, lovastatin, pravastatin)
  • 13.
    Page 13 Example 1.2 Localanesthetics □ bupivacaine Injection: 0.25%; 0.5% (HCl) in vial ephedrine Injection: 30mg (HCl)/mL in 1-mL ampule (Spinal anesthesia during delivery, prevent hypotension) Indicates multiple Therapeutic Equivalent agents (e.g. Ropivacaine, Mepivacaine, Levobupivacaine) Core Medicine Complementary Medicine WHO Model List of Essential Medicines 15th List March 2007 Page 13
  • 14.
    Page 14 Updating theList • Updated every 2 years by expert committee • New medicines or updates are submitted via application • Expert committee reviews applications and available data and recommend medicines to add http://www.who.int/topics/essential_medicines/en/ Page 14
  • 15.
    Page 15 Medicine Applications:Additions, Updates or Deletions • Application submitted or supported by a WHO group • Organizations consulted and/or supporting the application • Public health relevance of drug • Includes comparative efficacy, safety and cost- effectiveness • International availability (manufacturers) • Regulatory status (in country of origin and abroad) • Availability of pharmacopoeia standards (USP) http://www.who.int/selection_medicines/committees/AppForm.pdf Page 15
  • 16.
  • 17.
    Page 17 Reasons Forthe List • Portion of health dollars spent on pharmaceuticals – Developed countries 20% – Transitional countries 15-30% – Developing countries 25-66% • Pharmaceuticals are largest public expenditure on health after personnel costs in low income countries http://www.who.int/topics/essential_medicines/en/ Page 17
  • 18.
    Page 18 Medicine Affordability Comparisonof household income to percentage of medicines obtained. WHO Medicines Strategy- Countries at the Core 2004-2007 Conclusion: In countries with income <$2/day, more patients go without some or all of their medicines compared to those with income >$10/day Page 18
  • 19.
    Page 19 More ReasonsFor The List • Lack of access to essential medicines • Irrational use of available medicines • Poor drug quality of available medicines Page 19
  • 20.
    Page 20 Limited MedicationAvailability in the Developing World Percentage of essential medicines available for use in specified countries in public and private healthcare facilities. Medicines are not readily available for use irrespective of patient ability to purchase WHO Medicines Strategy- Countries at the Core 2004-2007 Page 20
  • 21.
    Page 21 Benefits • Evidence-basedrationale for the appropriate use of medicines • Cost justification for purchasing decisions • Allows for individualization to a country’s public health needs Page 21
  • 22.
    Page 22 How theList is Used: Country-Specific Formulary • Can be implemented on a Country, Provincial or Institutional Level • Customizable – To clinical guidelines for health care practice – To region-specific public health issues – To least costly or most accessible therapeutic equivalent Page 22
  • 23.
    Page 23 Country-Specific (continued) •In 2008 – 156 of 193 WHO member states have official Essential Medicines Lists – 127 of 156 have updated lists in the past 5-10 years – Some have State and/or Provincial lists http://www.who.int/topics/essential_medicines/en/ Page 23
  • 24.
    Page 24 Countries withEssential Medicines Lists, 2002 WHO Policy Perspectives on Medicines No. 04 June 2002 Page 24
  • 25.
    Page 25 How theList is Used: International Governmental Organizations • United Nations Children’s Fund (UNICEF) • United Nations High Commission for Refugees (UNHCR) • Guides: – Procurement – Reimbursement – Donations Page 25
  • 26.
    Page 26 How theList is Used: Non- Governmental Organizations (NGOs) • International Federation of the Red Cross and Red Crescent Societies • Médecins Sans Frontières (MSF)/ Doctors without Borders) • Oxfam • These groups’ medicines policies are based on the Essential Medicines List concept Page 26
  • 27.
    Page 27 How theList is Used: Special Indications • UN List of Emergency Relief Items • Essential Medicines for Reproductive Health • Children’s Essential Medicines • Interagency Emergency Health Kit Page 27 These lists have been instituted to supplement the full essential medicines list for specific indications. There is now a full children’s essential medicines list that specifically incorporates pediatric dosage forms (e.g. suspensions, chewable tablets, disintegrating tablets). This list was first published in 2007 and is separate from the essential medicines list. The Emergency Kits are designed to provide medicines that would be effective and needed in any form of emergency (e.g. war, natural disaster, humanitarian crisis). MSF/Doctors without Borders also uses this concept in its emergency kits.
  • 28.
    Page 28 Practical ApplicationsOf The List • Essential Medicines List is implemented at the governmental level, but there are barriers • Barriers – Infrastructure inadequacies (warehousing, distribution system, cold chain maintenance) – Social Inequalities/Poverty – Regulatory authorities, constraints – Intellectual Property Rights (patent protection) – Opposition of medical and pharmaceutical associations Page 28
  • 29.
    Page 29 Barriers: Infrastructure ATractor Trailer truck Driving along Highway 1 In Niger, West Africa Page 29
  • 30.
    Page 30 Barriers: Infrastructure •Distribution of medicines to clinics, especially rural areas – Lack of roadways, adequate transportation vehicles, cold- chain • Inadequate number and training of healthcare workers • Limited or no access to clean water or sanitation facilities The world health report 2006 – Working together for health. Geneva, WHO Page 30 These infrastructure barriers have become a recurring theme when discussing healthcare in the developing world and are closely intertwined with poverty both at the national and individual level. A thorough discussion of these factors is outside of the scope of this learning module, but should be understood as significant barriers to implementing the essential medicines concept.
  • 31.
    Page 31 World Distributionof Health Care Workers Health care workers include people who provide health services, management, and support workers (e.g. cooks, driver, cleaners etc.) The world health report 2006 – Working together for health. Geneva, WHO Page 31
  • 32.
    Page 32 Barriers: SocialInequalities and Poverty • Inability to afford medicines, both individuals and nations • Inadequate amounts of clean water or sanitation facilities • Gender inequality • Class discrimination • Access to the healthcare system Dying for Change Geneva WHO, World Bank 2002 Page 32
  • 33.
    Page 33 Barriers: Regulatory •Ability of a nation to regulate medicines including: – Good Manufacturing Practices (GMP) – Review of clinical trial data for safety, efficacy ± cost- effectiveness • Or, ability of nation to produce medicines: – Manufacturing infrastructure, GMP – Obtain, interpret safety and efficacy data Page 33 The regulation of medicines by the government ensures the safety and efficacy of drug products. This regulation requires significant investment by the government to review clinical trial data, ensure appropriate manufacturing practices and maintain the safety of the drug supply. The human capital required to accomplish these task is a barrier in many developing countries with relatively small budgets.
  • 34.
    Page 34 Barriers: IntellectualProperty Rights • World Trade Organization (WTO) Agreement on Trade- Related Aspects of Intellectual Property Rights (TRIPS) – Requires all countries to respect current patents and establish ways to protect those patents, especially for brand name pharmaceuticals – All medicine purchasers have to pay the price negotiated with the patent holder for the branded medicine, no generics can be made or purchased – But, the WTO agreed to a “Public Health Emergency Clause”… Agreement on Trade-Related Aspects of Intellectual Property Rights, Geneva, World Trade Organization 1994 Page 34
  • 35.
    Page 35 TRIPS (continued) •In the event of a public health crisis, countries may issue “compulsory licenses” for medicines • Allows medicines to be produced or imported without regard to patent law • However…... – What constitutes a “public health crisis”? – In a country with infrastructure problems, how can they produce medicines? – If patents are respected worldwide, where can a country find generic medicines? Page 35
  • 36.
    Page 36 A fullreview of international intellectual property rights regulation is outside of the scope of this learning module. Please see the module dedicated to this topic on the GHEC website. A basic overview follows. 1. TRIPS- Multilateral (e.g. between multiple countries, in this case all WTO countries) trade agreement that extends patent protection to intellectual property including pharmaceuticals. Established time frame for all countries to be in compliance with the regulations. Contained a public health crisis clause that would allow a country to issue a compulsory license for a pharmaceutical; effectively allowing a patented medicine to be produced or imported as a generic with a small fee paid to the patent holder. Only allowed if the country issuing the compulsory license is unable to reach an agreement with the patent holder. 2. Doha Declaration- Allowed for countries to determine their own public health crisis. Reinforced the legality of issuing compulsory licenses. 3. TRIPS-PLUS- Bilateral (e.g. between two countries, usually the United States and a developing country) trade agreement that removes the public health crisis clause. TRIPS (continued
  • 37.
    Page 37 Compulsory LicensesExplained, Sort of…The Doha Declaration • The Doha Declaration on Primary Health Care (2001) reiterated the concept of access to essential medicines • Determines that “public health crisis” should be interpreted based on each country’s needs • Compulsory licenses can be issued for any medicine that would satisfy those needs • Problem presumably “solved”… Doha Ministerial Declaration, Geneva World Trade Organization 2001 Page 37
  • 38.
    Page 38 Consequences ofDoha Declaration • Most countries can still not afford to produce their own medicines, but generics can now be imported (e.g., from India, Brazil) • Countries that have issued compulsory licenses have faced sanctions from the developed world (e.g., South Africa issued licenses for some anti-retrovirals to treat HIV/AIDS in the 1990s and faced sanctions from the United States) Page 38
  • 39.
    Page 39 Consequences (continued) •Bilateral Trade Agreements (between two countries only) • Known as TRIPS Plus, agreements are usually between the U.S. and a developing country • Agreements specifically exclude the public health crisis and compulsory licenses provision • Overrides the original WTO TRIPS agreement Page 39
  • 40.
    Page 40 Notes onConsequences. Bilateral trade agreements are usually between a developed country (e.g. the United States, European Union countries etc.) and a developing country. These agreements are generally stricter than the TRIPS agreement, especially in the ability of developing countries to issue compulsory licenses. For example, the U.S. may enter into an agreement with a developing country that offers that country a more favorable trade relationship. In return, the developing country agrees to more stringent patent protection on goods from the U.S. The developing country may no longer be able to issue a compulsory license on a medication from a U.S. pharmaceutical manufacturer. But, these bilateral agreements, being only between two countries, do no effect the developing countries ability to issue a compulsory license on a medicine produced by a E.U. pharmaceutical company, (assuming there are no other bilateral trade agreements in effect) TRIPS would still apply in that relationship.
  • 41.
    Page 41 Opposition fromMedical and Pharmaceutical Associations • Some policies focused on rationale use of medicines through clinical guidelines, believed to limit clinician judgment or choice (opposed by medical associations) • Some focused on promoting country specific pharmaceutical companies, limiting access to other medicines (opposed by pharmaceutical companies) • Some limited to only generic medicines (opposed by both medical and pharmaceutical associations) Page 41
  • 42.
    Page 42 Take HomePoints… • Essential Medicines are an indispensible component of a healthcare system • WHO provides an Essential Medicines List that may be used as a framework for developing a national, regional or NGO formulary • The WHO list is updated biannually by expert committee and takes into account new medicines, efficacy, safety and cost-effectiveness Page 42
  • 43.
    Page 43 Take HomePoints (continued) • The Essential Medicines concept has been widely adopted in WHO member countries, though widespread access to these medicines is still limited • Numerous barriers to implementing the list still exist, specifically infrastructure development problems and international agreements on intellectual property rights that limit medicine availability • Many of the barriers in implementing essential medicines are similar if not identical to barriers facing widespread health care system development Page 43
  • 44.
    Page 44 Case Study:Thailand and Compulsory Licenses Page 44 • Context: Thailand is experiencing an HIV/AIDS epidemic. There are a limited number of anti-retroviral treatment options available. One of the mainstays of treatment at this time is a combination protease inhibitor known as Kaletra ® (lopinavir/ritonavir) produced by Abbott Laboratories. At the time there is no generic available. • Problem: The cost of treatment with Kaletra is more than the Thai government is able to afford. Abbott Laboratories is unable to negotiate a compromise on price with the government. • Solution: The Thai government exercised its legal right to issue a compulsory license to import and produce a version of Kaletra to treat a public health crisis. The government complied with all aspects of TRIPS and the Doha Declaration. • Effects: Abbott Laboratories withdrew all applications for new products to be introduced in Thailand including a heat-stable version of Kaletra. Abbott also ceased shipping all of its pharmaceuticals to Thailand. Thailand was placed on the United States Priority Watch List; a list of nations that have “violated” international treaties on intellectual property. Abbott eventually was able to negotiate with the government on a price comparable with available generics. Thailand has not rescinded the compulsory license. • Analysis: Thailand was within its legal rights to issue a compulsory license for Kaletra after negotiations with Abbott failed to render a compromise. The government also agreed to pay Abbott 0.5% of the proceeds from the license. The repercussions, however, were quick and severe. Thailand lost access to many more medicines than it gained. Thailand also remains on the U.S. Priority Watch List, hindering future trade negotiations with the developed world.
  • 45.
    Page 45 Quiz • Nowwe invite you to take the module quiz and test your recent learning. • This module quiz includes 5 multiple choice questions • Note your answers on a piece a paper and then check them against the correct responses • After completing your quiz, come back for the general references of this module presentation.
  • 46.
    Page 46 1. Whichof the following is NOT part of the rationale for the creation of the Essential Medicines List? A Medicines are one of the largest expenditures of healthcare dollars in developing countries B Essential medicines are a necessity to the provision of primary health care C Essential medicines help to protect intellectual property rights D Essential medicines correspond with priority health needs 2. A novel antifungal was recently approved in the European Union. It is only available as an intravenous formulation and is minimally more effective than current antifungals. Where would this medicine be added on the Essential Medicines List? A The Core List B The Complementary List C A Therapeutic Equivalent D It would not be added to the list at this time
  • 47.
    Page 47 3. Theconcept of essential medicines has been instituted in most countries throughout the world. Which of the following is NOT a direct benefit of the essential medicines list? A Provided a clinical guideline for the appropriate use of medicines B Increased availability of medicines in healthcare systems C Focused on region specific health public health issuesIncorrect D Guided use to least costly or most widely available medicines 4. Achieving full implementation of the essential medicines list has been derailed by numerous barriers. Which of the following barriers is considered mostly a developed world impediment to the goals of the list? A Intellectual property rights and patent law B Poverty at either a personal or country level C Inadequate numbers of healthcare workers in the developing world D Distribution and cold-chain supply problems
  • 48.
    Page 48 5. TheTRIPS agreement by the WTO is a major barrier to access medicines in developing countries. Which of the following best describes the current state of thinking regarding TRIPS by most developing countries? A TRIPS agreements are legal documents that must be complied with fully; compulsory licenses are effectively illegal B The multilateral trade agreements do not fully protect intellectual property and must be supplemented by more stringent bilateral agreements C Compulsory licenses may only be issued during significant public health crises and will be limited to the duration of the crisis (e.g. cholera outbreaks D Compulsory licenses can and should be issued to treat public health crises as determined by the developing country but only after negotiations with the patent holder have failed to produce an effective solution
  • 49.
    Page 49 And nowfor the answers to the questions
  • 50.
    Page 50 1. Whichof the following is NOT part of the rationale for the creation of the Essential Medicines List? A Medicines are one of the largest expenditures of healthcare dollars in developing countries -- Incorrect. -- Medicines account for up to 60% of healthcare dollars spent in developing countries B Essential medicines are a necessity to the provision of primary health care Incorrect. -- Essential medicines are specified in the Alma-Alta Declaration on Health C Essential medicines help to protect intellectual property rights -- Correct. - - Intellectual property rights are considered a barrier to the implementation of essential medicines D Essential medicines correspond with priority health needs -- Incorrect.
  • 51.
    Page 51 2. Anovel antifungal was recently approved in the European Union. It is only available as an intravenous formulation and is minimally more effective than current antifungals. Where would this medicine be added on the Essential Medicines List? A The Core List -- Incorrect. -- While this medicine may treat a priority condition, it requires special administration (IV) and is only minimally more effective than current treatments B The Complementary List -- Incorrect. -- This may be an appropriate category for the medicine, however without cost-effectiveness or cost-comparison information, the medicine will not be added or reviewed. C A Therapeutic Equivalent -- Incorrect. -- This is a novel new medicine and most likely will not have a therapeutic equivalent D It would not be added to the list at this time -- Correct . -- Without cost information, this medicine will not be reviewed or added to the essential medicines list
  • 52.
    Page 52 3. Theconcept of essential medicines has been instituted in most countries throughout the world. Which of the following is NOT a direct benefit of the essential medicines list? A Provided a clinical guideline for the appropriate use of medicines B Increased availability of medicines in healthcare systems -- Correct. -- This is the overall intention of the list, but the list does not directly increase availability of medicines C Focused on region specific health public health issuesIncorrect D Guided use to least costly or most widely available medicines
  • 53.
    Page 53 4. Achievingfull implementation of the essential medicines list has been derailed by numerous barriers. Which of the following barriers is considered mostly a developed world impediment to the goals of the list? A Intellectual property rights and patent law -- Correct. -- These laws were propagated by the developed world and pharmaceutical companies to inhibit local production of medicines in the developing world B Poverty at either a personal or country level -- Incorrect. -- While the origins of developing world poverty may be attributable to colonization or imperialism, it is generally not considered that the developed world is imposing poverty on developing countries C Inadequate numbers of healthcare workers in the developing world -- Incorrect. -- Though healthcare workers trained in the developing world are more likely to immigrate to developed countries, this it not due to any developed countries policies. In many developed countries, there are policies regarding training healthcare workers from the developing world, but not allowing them to receive visas or immigration status after completing their training D Distribution and cold-chain supply problems -- Incorrect.
  • 54.
    Page 54 5. TheTRIPS agreement by the WTO is a major barrier to access medicines in developing countries. Which of the following best describes the current state of thinking regarding TRIPS by most developing countries? A TRIPS agreements are legal documents that must be complied with fully; compulsory licenses are effectively illegal -- Incorrect. -- Most countries recognize the validity of compulsory licenses for public health B The multilateral trade agreements do not fully protect intellectual property and must be supplemented by more stringent bilateral agreements -- Incorrect. -- Developed countries, particularly the United States, have taken this stand point C Compulsory licenses may only be issued during significant public health crises and will be limited to the duration of the crisis (e.g. cholera outbreaks -- Incorrect. -- This is the assumed original intent of the compulsory license clause. These licenses would be issued for a limited duration for diseases that could be effectively cured in the short term; it was not intended for chronic diseases (e.g. HIV/AIDS) D Compulsory licenses can and should be issued to treat public health crises as determined by the developing country but only after negotiations with the patent holder have failed to produce an effective solution -- Correct. -- Most developing countries have taken this approach to maintain current trade relations with the developed world while managing the welfare of their own population
  • 55.
    Page 55 Page 55 GeneralReferences Papers: • Sridhar D, Improving Access to Essential Medicines: How Health Concerns can be Prioritised in the Global Governance System. Public Health Ethics. 2008,1(2):83-88 • Koivusalo M, Mackintosh M. Global Public Action in Health and Pharmaceutical Policies: Politics and Policy Priorities. The Open University February 2009 Web Links: • WHO Essential Medicines http://www.who.int/topics/essential_medicines/en/ Gateway to the WHO program on essential medicines including the Expert Committee, Published Essential Medicines Lists and statistics. • WHO http://www.who.int Entry to the WHO website. Provides access to published reports, statistics and WHO programs. • WTO http://www.wto.org Entry to the World Trade Organization website. Provides access to published reports, statistics and WTO trade agreements.
  • 56.
    Page 56 Credits Brian M.Kaiser Pharm.D. Pharmacy Practice Resident University of California, San Francisco
  • 57.
    Sponsors The Global HealthEducation Consortium gratefully acknowledges the support provided for developing these teaching modules from: Margaret Kendrick Blodgett Foundation The Josiah Macy, Jr. Foundation Arnold P. Gold Foundation This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 3.0 United States License.
  • 58.
  • 59.
    Slide 5: DefiningEssential Medicines The full definition of essential medicines is given below. The main point of this definition is to reinforce that the list is not a permanent list of must have medicines but rather a guide. Each country must determine its own list based on the current and future public health needs, and availability of medicines. Essential medicines are those that satisfy the priority health care needs of the population. They are selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost- effectiveness. Essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford. The implementation of the concept of essential medicines is intended to be flexible and adaptable to many different situations; exactly which medicines are regarded as essential remains a national responsibility. Page 59 to Slide 5
  • 60.
    Slide 11: Therapeutic Equivalence Therapeuticequivalence indicates that medicines have similar clinical efficacy, though there may be some benefits of one medicine over another based on dosing frequency or side effect profile. In the U.S. the most common example of drugs with therapeutic equivalence are the HMG-CoA Reductase Inhibitors or “Statins” (e.g. Rosuvastatin, atorvastatin, simvastatin, lovastatin, pravastatin) to Slide 11 Page 60
  • 61.
    Slide 26: Howthe List is Used: Special Indications These lists have been instituted to supplement the full essential medicines list for specific indications. There is now a full children’s essential medicines list that specifically incorporates pediatric dosage forms (e.g. suspensions, chewable tablets, disintegrating tablets). This list was first published in 2007 and is separate from the essential medicines list. The Emergency Kits are designed to provide medicines that would be effective and needed in any form of emergency (e.g. war, natural disaster, humanitarian crisis). MSF/Doctors without Borders also uses this concept in its emergency kits. to Slide 26 Page 61
  • 62.
    Slide 29: Barriers:Infrastructure These infrastructure barriers have become a recurring theme when discussing healthcare in the developing world and are closely intertwined with poverty both at the national and individual level. A thorough discussion of these factors is outside of the scope of this learning module, but should be understood as significant barriers to implementing the essential medicines concept. to Slide 29 Page 62
  • 63.
    Slide 32: Barriers:Regulatory The regulation of medicines by the government ensures the safety and efficacy of drug products. This regulation requires significant investment by the government to review clinical trial data, ensure appropriate manufacturing practices and maintain the safety of the drug supply. The human capital required to accomplish these task is a barrier in many developing countries with relatively small budgets. to Slide 32 Page 63
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    Slide 33: Barriers:Intellectual Property Rights Back Page 64 For notes, see Teaching Modules Appendix: http://globalhealtheducation.org/Modules/Teachi ng%20Modules%20Appendix/106.aspx.
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    Note G: Consequences Bilateral tradeagreements are usually between a developed country (e.g. the United States, European Union countries etc.) and a developing country. These agreements are generally stricter than the TRIPS agreement, especially in the ability of developing countries to issue compulsory licenses. For example, the U.S. may enter into an agreement with a developing country that offers that country a more favorable trade relationship. In return, the developing country agrees to more stringent patent protection on goods from the U.S. The developing country may no longer be able to issue a compulsory license on a medication from a U.S. pharmaceutical manufacturer. But, these bilateral agreements, being only between two countries, do no effect the developing countries ability to issue a compulsory license on a medicine produced by a E.U. pharmaceutical company, (assuming there are no other bilateral trade agreements in effect) TRIPS would still apply in that relationship. Back Page 65