The Concept of Essential Medicines and the WHO Model List of Essential Medicines

1. The Concept of Essential Medicines and the WHO Model List of Essential Medicines Technical Briefing Seminar 29th October 2013 Department of Essential Medicines and Health Products (EMP) World Health Organization,

2. Essential medicines • The concept of essential medicines A limited range of carefully selected essential medicines leads to better health care, better drug management, and lower costs • Definition of essential medicines Essential medicines are those that satisfy the priority health care needs of the population • Selection of essential medicinesSelected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness.

3. History of the WHO Model List of Essential Drugs • 1977 First Model list published, ± 200 active substances • List is revised every two years by WHO Expert Committee • 2002 Revised procedures approved by WHO • Last revision (April 2013) contains approx. 374 active substances The first list was a major breakthrough in the history of medicine, pharmacy and public health Médecins sans Frontières, 2000

4. Why is it 'model' • Model for process of selection (Is it the first example of Health Technology Assessment?) • Model list • Model to facilitate efforts to 'improve health' of population Procurement and Supply Regulation Quality Rational Use Availability Access Equity

5. Full description of essential drugs(Expert Committee Report, April 2002) Definition: Essential medicines are those that satisfy the priority health care needs of the population Selection criteria: Essential medicines are selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness Purpose: 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 at a price the individual and the community can afford. Implementation: 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.

6. The Essential Medicines Target National list of essential medicines Registered medicines All the drugs in the world Levels of use CHW S S dispensary Health center Supplementary specialist medicines Hospital Referral hospital Private sector

7. National Essential Drugs List < 5 years (127) > 5 years (29) No NEDL (19) Unknown (16) Number of countries with a national list of essential medicines (Outdated) 156 countries with EDLS 1/3 within 2 years 3/4 within 5 years

8. Use of the WHO Model List of Essential Drugs • 156 countries have a national list of essential drugs, of which 81% have been updated in the last 5 yearsCountries with an official selective list for training, supply, reimbursement or related health objectives. Some countries have selective state/provincial lists instead of or in addition to national lists. • Major international agencies (UNICEF, UNHCR, IDA) base their catalogue on the WHO Model List • Sub-sets: UN list of recommended essential drugs for emergency relief (85 drugs); interagency New Emergency Health Kit (55 drugs for 10,000 consultations) • Normative tools: WHO Model Formulary, International Pharmacopoea, Basic Quality Tests, and development of reference standards follow the WHO Model List

9. Model process :Seven steps to get a new medicine onthe WHO Model List of Essential Drugs 1. Identification of public-health need for a medicine 2. Development of the medicine; phase I - II - III trials 3. Regulatory approval in a number of countries > Effective and safe medicine on the market 4. More experience under different field circumstances; post-marketing surveillance 5. Price indication for public sector use 6. Review by WHO disease programme; define comparative effectiveness and safety in real-life situations, comparative cost-effectiveness and public health relevance > Medicine included in WHO treatment guideline 7. Submission to WHO Expert Committee on Essential Drugs > Medicine included in WHO Model List

11. Process - Evidence Based and Transparent • Applications invited - addition/deletion/modification • Format available; Deadline a few months before next EC • All applications go online • Applications peer reviewed by experts • Peer reviews go online • Comments invited from any one interested (WHO Depts., Professional Societies, International agencies, Academia) • Comments go on line • Expert Committee makes final decisions • Report goes on line • (Unfortunately very few countries follow this procedure – usually closed door session and list announced)

12. Criteria ForExpert Committee approval • Effective and safe medicine– based on clinical trials data, post marketing surveillance, pharmacovigilance, regulatory approvals • Regulatory approval in a number of countries - indicates availability, efficacy, safety • Available in most parts of the world and ease of use in different settings -necessary for access • Public health need - indicated by burden of disease, populations served, annual estimates of use, guideline recommendations • Affordable for most health care systems - costs comparisons, cost benefit • Recommended in Guidelines especially by WHO programmes – indicates public health need, efficacy, safety

13. The WHO Model Essential Medicines List is NOT • A list of cheap drugs for developing countries • All the drugs for all the diseases in the world – medicines in it are for priority health conditions • Drugs of unproven efficacy • One that has "latest drugs" – they have to be proven in practice before they are adopted • One that has multiple medicines from the same therapeutic category (one beta blocker out of the 50+) – How many benzodiazepines does the United Kingdom have? How many of them are available through the NHS?

15. National Essential Medicines Lists :Implementation in Countries (156!) • How operational is it in Low and Middle Income countries?(Is procurement tied to the NEML?) • What are the LMICs that have the best implementation of the National Essential Medicines List? • What is the underlying factor for success in these countries?

16. National Essential Medicines Lists :Implementation in Countries (156!) • An overall coordinated health service in a country is necessary (Public + Private Sector) (United Kingdom?) • How important is the private (for profit) sector in health care in LMICs? • The Essential Medicines List is a good gatekeeper to the Medicines Supply of the Government Sector but is ignored by the Private Sector • Even in the public sector how common are the other tools for implementing the Essential Medicines List – Formularies, Standard Treatment Guidelines, Drug Information Centres?(British National Formulary)

17. National Essential Medicines Lists :Implementation in Countries – what are the issues? • Is there a sufficient number of drugs in national lists? • Are the lists updated regularly? • Is there any analysis on whether the majority of procurement is from the National Essential Medicines List? • Is the selection for the National List after a technical discussion OR done as a Bureaucratic/logistic exercise by the Ministry of Health ? • How transparent is the process? • Are their Declarations Of Interest for the committee members?

18. Conclusion • Essential medicines is a global concept • There is global implementation of the principle BUT it is done in some countries (especially HICs) by other names • The adoption of the Essential Medicines Concept and the List is almost universal in LMICs BUT the implementation is far from universal • Is a comprehensive health care system that values cost-effective medicines, a pre-requisite for implementing the Essential Medicines List?

19. Brief Report on the 19th Expert Committee on Selection and Use of Essential Medicines UPDATE Dr Krisantha Weerasuriya Secretary, Expert Committee on Selection and Use of Essential Medicines Policy, Access and Rational Use Essential Medicines and Health Products World Health Organization Essential Medicines and Health Products (EMP)

20. 19th Expert Committee • 19th Expert Committee held in Geneva, 8-12 April 2013 • 17th WHO Model List of Essential Medicines – Updated and 18th List • 3rd WHO Model List of Essential Medicines for Children – Updated and now 4th List • Executive Summary + 2 Lists – Published on the Essential Medicines website – 8 July 2013 • Full Technical Report (TRS98X) cleared • Will be published this week on the website Essential Medicines and Health Products (EMP)

21. 19th Expert Committee – What were the "hot" topics? • 50+ Applications + 15 Reviews • Oseltamivir – application for deletion • Pegylated interferon – Hepatitis C • Imatinib and trastuzumab – anticancer medicines • Bevacizumab – monoclonal antibody for Age-Related Macular Generation • Risperidone – second generation antipsychotic • Chlorhexidine gel – cord care in the newborn in deliveries in communities • Whole Blood as an Essential Medicine Essential Medicines and Health Products (EMP)

22. 19th Expert Committee –"Hot" topics and decisions • Oseltamivir – application for deletion – rejected – useful within the specified guidelines • Pegylated interferon – Hepatitis C – accepted – first treatment for hepatitis C in WHO Model List of Essential Medicines • Imatinib and trastuzumab – anticancer medicines – useful but whole section on anticancer medicines to be reviewed • Bevacizumab – monoclonal antibody for Age-Related Macular degeneration – not an approved indication but included in list • Risperidone – second generation antipsychotic - previously only chlorpromazine and haloperidol • Chlorhexidine gel – cord care in the newborn in deliveries in communities – how relevant to the majority of countries? • Whole Blood as an Essential Medicine Essential Medicines and Health Products (EMP)

23. 19th Expert Committee –"Hot" topics and decisions • Whole Blood as an Essential Medicine • Is blood a medicine? • Will making blood a medicine commercialise it and affect voluntary donation? • If made a "medicine" will bring it under "drug regulation" – will that improved regulation of blood? (Better supervision, implementation of quality control, donor testing etc.) • Final decision – blood included in the essential medicines list Essential Medicines and Health Products (EMP)

24. Conclusion • Dr K Weerasuriya, Medical Officer Policy Access and Rational Use (PAU) Essential Medicines and Health Products (EMP) World Health Organization CH-1211 Geneva 27 Switzerland • email: weerasuriyak@who.int • Comments and Questions welcome • There are Notes in some of the slides which explain the issue further.