HEALTH TECHNOLOGY Medicines, Vaccines, Laboratory, Devices, Equipment…

1. HEALTH TECHNOLOGYMedicines, Vaccines, Laboratory, Devices, Equipment… from policy to practice Zafar Mirza, Houda Langar, Nabila Metwalli, Adham Ismail H T P Team Department of Health Systems & Services Development Capacity Development Workshop on Health System Development EMRO, Cairo, June 8-12, 2008

2. What is a Health Technology ? • WHO defines Health Technologies as; “The application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of lives”. • This broad definition also encompasses traditional medicine, health promotion and prevention activities, and includes information systems (such as electronic medical records and telemedicine applications). WHA Resolution 60.29, May 2007.

3. Our Aim is… To assist member states in establishing and optimizing the use of technologies with multiple applications for health services in the fields of: • Medicines • Vaccines • Other Health Technologies including: • Blood products and related biologicals, as well as blood transfusion and injection safety. • Diagnostic Imaging and Medical Devices. • Diagnostics and Laboratory technology. • Emerging and essential surgical care and Transplantation • e-Health for Healthcare Delivery.

4. This Presentation • PART 1Health Technologies and Health Systems • PART 2Essential Medicines & Pharmaceutical PolicesZafar Mirza • PART 3Essential Vaccines and Biologicals Policy Houda Langar • PART 4Other Health Technologies Adham Ismail

5. PART 1Health Technologies & Health Systems

6. Health Technologies in WHO Health System Framework MEDICINES, VACCINES & OTHER HEALTH TECHNOLOGIES National Regulatory Authority

7. Medicines, Vaccines & other Health Technologies consume approximately 50% of recurrent health budget. Well over 50% of expenditure on Medicines, Vaccines & other Health Technologies is wasted due to one reason or the other.

8. Cosmetics Biotechnology Products Medical Devices Blood Products Vaccines Homeopathic Medicines HEALTH PRODUCTS & MEDICAL PRODUCTS Water Pharmaceuticals Laboratory facilities Food Herbal Medicines PESTICIDES Medical Equipment NEUTRACEUTICALS

9. Scope of National Regulatory Authorities Food . Bottled Water . Medicines . Medical Devices . Medical Equipment . Pesticidies . Cosmetics • Medicines for Human Use •  Pharmaceuticals •  Biologicals • - Vaccines • - Sera • - Blood products •  Pharmaceutical raw materials • Herbal Medicines •  Homeopathic Medicines • Medicines for • Veterinary Use

10. PART 2Essential Medicines & Pharmaceutical Policies

11. Expenditure on medicinesfrom 9 NHA studies in the Region 40% of total health expenditure is on medicines Up to 30% of the budget of ministries of health is spent on medicines Out-of-pocket expenditure is high Egypt: 53% of all medicines are purchased directly by households Morocco: 74%

12. WHO Medicines Strategy 2004 – 2007Our goal in medicines WHO’s goal in medicines is to help save lives and improve health by ensuring the quality, efficacy, safety and rational use of medicines, including traditional medicines, particularly for the poor and disadvantaged.

13. Objectives Policy Access Quality & safety Rational use Components Implementation and monitoring of medicines policies Traditional and complementary medicine Fair financing and affordability Medicines supply systems Norms and standards Regulations and quality assurance systems Rational use by health professionals and consumers WHO Medicines Strategy 2004 – 2007:4 objectives, 7 components, 44 expected outcomes

14. National Medicine Policiescommitment to goals and guide to action • Legislation, Regulation and Guidelines • Selection of Drugs • Supply (incl. procurement & production issues) • Quality Assurance • Rational Drug Use • Economic Strategies for Drugs • Monitoring & Evaluation of NDP’s • Research • Human Resources Development • Technical Cooperation among Countries

15. Essential Medicines in a “therapeutic jungle” • Safe • Efficacious • Proven quality • Time tested • Affordable, although price is no more a strict criteria • Cover needs of the majority of population

16. 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 centre Supplementary specialist medicines Hospital Referral hospital Private sector

17. Essential Medicines List • WHO Model List of Essential Medicines • first list in 1977 • Latest is15th revised version • 315 active ingredients • around 15 fixed-dose combinations • almost 99% are patent free • One of the 8 pillars of PHC • Equitable access to essential drugs is integral part of right to health • In poor countries almost half of the population do not have regular access to needed medicines • 156 countries have national EMLs

18. The WHO Essential Medicines Library WHO clusters WHO/EDM Summary of clinical guideline Clinical guideline WHO/BNF WHO Model Formulary WHO/EC, Cochrane, BMJ Reasons for inclusion Systematic reviews Key references WHO EM List WHO Model List WHO/PSM MSH UNICEF MSF Quality information: - Basic quality tests - Intern. Pharmacopoeia - Reference standards Statistics: - ATC - DDD Link to price information WCCs Oslo/Uppsala

19. The challenge of meeting essential medicine needs 1. Unaffordable medicine prices 2. Irrational Use of medicines 3. Unfair health financing mechanisms 4. Unreliable medicines supply 5. The quality of medicines 6. New medicines are needed

20. Survey FindingsAvailability of medicines in public sector health facilities Yemen 16/35 medicines were not found in any facility 29/35 medicines were available only in 4 facilities Pakistan 23/29 medicines were not found in more than 15 facilities Lebanon only 15 of the 32 surveyed medicines were found at 20 public dispensaries Morocco 20/34 medicines were not available in more than half the health facilities

21. Survey FindingsAffordability Number of days’ income a lowest paid government servant has to spend to buy pre-selected treatment regimes for 9 common diseases • Respiratory infection: 2.4 days’ income to buy a week’s supply of branded amoxicillin in Jordan • Depressive illness: 7.7 days’ income to buy a month’s supply of generic fluoxetine in Pakistan and 36.4 days’ income to buy branded fluoxetine • Ulcer: One month’s treatment with generic omeprazole – 2.9 days’ income in Sudan and 19.3 days’ income in Jordan; with originator brand 10.6 days’ income in Morocco and 23.7 days’ income in Pakistan

22. Irrational Use of Medicines • We estimate that more than half of all medicines are prescribed, dispensed or sold inappropriately, and that half of all patients fail to take them correctly. • Irrational use is a complex problem. • Solution requires collaborative efforts and different types of interventions (Educational, Managerial, Economic & Regulatory). • Experience shows that attention to one aspect of the problem does not work.

23. 10 national strategies to promote RUMneeds sufficient govt. investment for medicines & staff ! • Evidence-based standard treatment guidelines • Essential Drug Lists based on treatments of choice • Drug & Therapeutic Committees in hospitals • Problem-based training in pharmacotherapy in UG training • Continuing medical education as a licensure requirement • Independent drug information e.g bulletins, formularies • Supervision, audit and feedback • Public education about drugs • Avoidance of perverse financial incentives • Appropriate and enforced drug regulation

24. Part 2Essential Vaccines and Biologicals Policy

25. WHO’s Goal • Assured quality for 100% of vaccinesused in all national immunization program • Definition of assured quality:ECBS and recommendations on safety, efficacy and quality in WHO TRS): • National Regulatory Authorityindependent • National Regulatory Authority fully functional, • Non unresolved reported problem with vaccine

26. Why an efficient National Regulatory Authority? • Biologicals and complex products • Vaccines used for prophylactic purposes on healthy population • Ensure the quality, efficacy and safety of vaccines • Knowing all kind of vaccines circulating in the country and all lots marketed • Knowing the specifications of vaccines • AEFI causality assessment

27. Role of NRA • Ensure that vaccines released for use are evaluated properly and meet international standards: safety, efficacy and quality • Covering a cycle starting from vaccine development until the administration of the vaccine as well as after immunization • Define scientific documentationandcriteria for licensing • Issue, vary, suspend or withdraw licenses for vaccines on the basis of quality, safety and efficacy of vaccines

28. Role of NRA (Cont’d) • Continually oversee the quality of vaccines by releasing each lot intended for use in the country • Monitor the impact of vaccines in use through a well functioning surveillance system for safety and quality • Active role in vaccine procurement, management and best practices of use • Regular review of standardization and control of vaccines according to the current state of science and technology

29. Key elements for an efficient NRA • Government commitment • Legal basis • National Policy/strategy for regulation and control • Independence, competency, objectivity, impartiality, transparency & integrity • Effective Quality Management System: organization, responsibilities, communication, long term vision and strategic plan, skilled & qualified human resources and sustainable financial resources, documentary system (quality manual, procedures, records), tools, monitoring and evaluation

30. National Regulatory Functions & vaccine supply source

31. WHO Process to evaluate performance of regulatory system NRA Network of regulatory experts Benchmarking NRA assessment using tools 5 day assessment Planning to address gaps Institutional Development Plan GTN placement within 1-3 months Training & Technical assistance 15-24 months (6-8 months in needs much improvement) Follow - up visit

32. Situation in EMR • Vaccine producing countries: 3, 4 ? or 5? Egy, Ira, Pak, (Tun), (KSA) • GAVI eligible countries: (6) (through UNICEF, WHO PQ vaccines) Afg, Dji, Pak, Som, Sud, Yem • Self-procuring countries: KSA, Bah, Kuw, UAE, Qat, Oma, Syr, Jor, Lib, Tun, Egy, Ira • Countries procuring through UN agencies: Pal, Iraq, Leb, Mor • Private sector and non EPI vaccines: self-procurement • No NRA fully functional & No pre-qualified vaccines

33. Why is it recommended to use WHO prequalified vaccines ? • ASSURED QUALITY: Effective and reliable NRA • Evaluated by WHO • Initial evaluation of vaccines: Review of Product Summary file, testing of final product characteristics and consistency lots, evaluation of clinical data, Verification of GMP compliance • Regular reassessment • Continuous monitoring by WHO

34. WHO Challenges • Weak NRA status • Few vaccine producers, traditional vaccines only • Vaccine insecurity and no vaccine self-sufficiency: vaccine supply, affordability of price, assured quality • New vaccines, new formulation (combination), high cost • Emerging pandemic situation (pandemic flu) • Quality and access of sera/immunoglobulins: public health issue

35. Way Forward • Mapping vaccine regulatory system in EMR countries • WHO technical support for strengthening the NRAs • Regional network for control of vaccines: sharing information and experiences • Global network for Post-marketing surveillance • Improving the vaccine procurement system • Vaccine self-sufficiency (strengthening vaccine production, pooled vaccine procurement) • New guidelines

36. Part 3Other Health Technologies

37. Targeted Technologies • Blood Transfusion Safety • Blood Safety. • Injection Safety. • Infection Prevention and Control. • Clinical Procedures • Emergency Surgical Care. • Essential Clinical Procedures • Transplantation • Diagnostic Imaging and Medical Devices • Diagnostic Imaging. • Medical Supplies and Instrumentations. • Medical Equipment. • Diagnostics and Laboratory Technology • Diagnostics and Lab Supplies. • Laboratory Services

38. Main Thrust • The main thrust is to assist MS in establishing and optimizing the selection, procurement and use of health technologies with multiple applications for service delivery. • To achieve this, we need adequate Assessment and proper Management

39. What is HT Assessment (HTA)? • HTA is a multi-disciplinary activity that examines the effect of technologies on: • Available Resources, • Cost & Cost-effectiveness, • Technical Aspects (ex. safety & efficacy) • Other Aspects (ex. legal & ethical issues) • HTA goal is to • Provide input to decision-making in policy and practice. • Ensure value for money. • Develop a department within NRAs to deal with Medical Devices, as well as other technologies.

40. How to assess HT Needs? • A tool (e.g. a questionnaire) is neededfor proper assessment of needs. • The questionnaire provides Structural, Processand Management indicatorsof all HT aspects in each country. • Using this common approach allow comparisons between MS, and suggest regional strategies.

41. HTA & Utilization of resources: Medical Equipment Study Prior to use After use Source: Swiss Center for International Health, Basel, 2005

42. HTA of Technical Aspects: Procurement of MRI

43. Why do we need Health Technology Management (HTM)? • Health technologies provide an opportunity for a better service • Lack of national systems for standardizing their selection and use may lead to a disproportionate escalation in delivery costs • To reap the maximum benefits, proper health technology management plans should be developed • To conserve resources, countries need clear evidence-based plans on how to: • Conduct proper needs assessment • Assess cost-effectiveness of technologies • Develop policies on rational selection and use • Regulate public-private purchasing decisions

44. HTM Components Selection Management Support Organization Financing Information Management Human Resources Use Procurement Distribution

45. HTM: Proper Selection and Adequate Procurement • Many interacting factors determine the type of technology to be used. • For example, in medical devices, the factors could be: • Type of disease under consideration and associated level of healthcare delivery (primary, secondary, tertiary) • Type and structure of the health facility (hospital, centre, etc.) • Public health conditions and/or situations (normal, disasters, emergencies, etc.) • In medicines, selecting and procuring medicines to meet the needs of the population are affected by: • Medicine quality, prices and supply. • Health financing mechanisms • New medicines

46. “Priority” Medical Devices and Clinical Procedures • As with WHO model list of “Essential Medicines”, a similar list for “Priority” devices and procedures can be useful in developing national policies. • The aim is to introducesimple technologies that address health problems, especially in under-resourced areas. • WHO should provide guidance on minimum set of devices & procedures critical for HS to be functional and efficient. • This set should be dynamic and country-specific. • This requires • Using a single uniform nomenclature system (GMDN or UMDNS). • Preparation of integrated & interrelated data sets on devices, procedures, resources, etc. • A methodology for assessment of needs, selection, acquisition and management of HT. • Prioritization schemes that rely on BOD, existingresources, etc.

47. WHO & Essential HT • Blood and Blood Transfusion Safety • Gaps in availability of blood . • Promotion of voluntary donation. • Focus is on blood safety through capacity development and technical expertise. • Use of WHO collaborating centers. • Rational use of blood products • Safe injections & infection prevention/control • Rehabilitation of blood transfusion services

48. WHO & Essential HT (Cont.) • Diagnostics and Lab Technology • Rehabilitation of lab networks to support service delivery at different levels. • Focus is on capacity development. • Improvement of quality using external/internal assurance schemes and SOPs. • Reducing antimicrobial resistance & containment and control of hospital infections. • Improving bio-safety and bio-security • Improving accessthrough linkages with surveillance and epidemiology departments.

49. WHO & Essential HT (Cont.) • Diagnostic Imaging, Medical Devices and Clinical Procedures • Accessible, safe and reliable diagnostic imaging. • Increased patient safety by ensuring access to safe and effective medical devices. • Strengthened capacity at PHC facilities to provide emergency/essential surgical care. • Improved access to ethical, safe and suitable transplantations. • Strengthened services through e-Health.

50. Conclusions • HT are important building blocks and resources of HS. • To avoid huge wastageof resources and ensure adequate access, investments need to be made in developing appropriatepolices, strategies and management systems (selection, procurement, storage, supply & maintenance). • Safety and quality of HT require institutional development of resourceful NRA with appropriate independence in technical, administrative and financial decision making. • Appropriate use of HT needs urgent attention. • HT must be regulated for its affordability. • Unimpeded transfer of technologybetween countries needs to be controlled.