Legislations and Policies in Jordan/ Related to Health and Pharmaceuticals April 19, 2018

Transcription

1 Legislations and Policies in Jordan/ Related to Health and Pharmaceuticals April 19, 2018 Dr. Rania Bader, HRH2030 Health Workforce Competency Lead

2 HRH2030 The Human Resources for Health (HRH2030) is a five-year USAID-funded activity that supports the Ministry of Health (MOH), High Health Council (HHC), and other national health stakeholders to strengthen the health workforce to improve the delivery of health services.

3 HRH2030 Objectives The project has three objectives: Improved Human Resource Practices at the MOH Improved Health Workforce Competency Strengthened National HRH Governance

4 Topics in this lecture: We will cover two examples under Health Legislations and Policies in Jordan, : 1- Bylaw for Renewing Licenses of Health Professionals. 2- Legislations and Policies Related to Pharmaceuticals.

5 Bylaw for Renewing Licenses of Health Professionals

6 Bylaw for Renewing Licenses of Health Professionals Steps undertaken to develop the bylaw: 1. Stakeholder Analysis/ technical support from HRH2030 Stakeholder analysis is a technique used to identify and assess the importance of the main players, institutions and organizations that significantly influence the success of developing or implementing a policy.

7 Bylaw for Renewing Licenses of Health Professionals 2. In July 2017, the Minister of Health appointed a national relicensing committee (RC), headed by the secretary general of the High Health Council (HHC) and made up of key stakeholders. 3. The main purpose of the RC is to develop a bylaw for renewing licenses of health professionals every 5 years based on obtaining continuing professional development (CPD) units. 4. HRH2030 acted as the secretariat and provided technical assistance to the RC.

8 Bylaw for Renewing Licenses of Health Professionals 5. Country Comparison: HRH2030 drafted a summary report on current best practices in renewing licenses for health professionals based on obtaining CPD units in different countries to inform the RC. 6. A Policy Review: HRH2030 reviewed existing laws, bylaws, and regulations that address CPD and renewing licenses of health professionals to inform the RC.

9 Bylaw for Renewing Licenses of Health Professionals 7. RC identified that the bylaw can be speculated from Paragraph (a) Article (6) of Public Health Law, No (47) of the year RC developed the first draft of the bylaw and sent it to MOH. 9. The MOH legal advisor reviewed and sent the bylaw to the Prime Ministry Council (received first approval). 10. The Prime Ministry Council sent the bylaw to the legislation and opinion bureau (LOB) for legal review.

10 Bylaw for Renewing Licenses of Health Professionals 11. The bylaw was published on November 26 at the LOB website (for 2 weeks) for public comments.

11 Bylaw for Renewing Licenses of Health Professionals 12. LOB legal advisors discussed all comments with relevant people and institutions. 13. LOB sent back the revised the bylaw to MOH. 14. LOB held a consensus cession with key stakeholders. 15. LOB sent the final version of the bylaw to the Prime Ministry Council for endorsement (second approval). 16. The final version was sent for His Majesty s signature. 17. The bylaw was published in the Official Gazette on April 1.

12 Bylaw for Renewing Licenses of Health Professionals

13 National CPD System A national CPD system provides benefits for health workers, health facilities, regulatory bodies, the government and patients. A national CPD system reinforces individual practitioner and collective provider accountability, and promotes practicing in accordance with ethical principles to meet patients needs. A national CPD system leads to improved clinical services and patient outcomes.

14 Added Value of CPD Increasing health professionals productivity. Improving motivation and retention of health professionals. Addressing health professionals shortages and implementing task-sharing. Strengthening the health system as a whole. Improving patient care.

15 CPD Activities That practitioners participate in inside or outside Jordan to develop their professional performance. Trainings Publications Seminars Courses Workshops Conferences

16 Bylaw for Renewing Licenses of Health Professionals No. (46) Year 2018

17 What is the bylaw for renewing licenses of health professionals? Who should renew their licenses? What are the requirements for license renewal? The bylaw states that health professionals should renew their licenses every five years after fulfilling the licensing requirements of each profession and the requirements of continuing professional development (CPD) activities. Licensed Jordanian and non-jordanian health professionals working in Jordan. Fulfill the basic licensing requirements according to the provisions of the governing legislations and bylaws of each profession. Obtain a certificate stating that health professionals have received a number of CPD credit hours for each profession according to the instructions issued for this purpose. Pay the license renewal fees. Obligatory five years have passed since the previous license or license renewal. What are the CPD activities? Who Should Approve CPD Activities? Who should keep the records of licensed health professionals? Who is responsible for license renewal? Courses Workshops Conferences Trainings Publications Seminars That practitioners participate in inside or outside Jordan to develop their professional performance. Jordan Medical Council for physicians, dentists, and pharmacists. Jordan Nursing Council for registered nurses and midwives. High Health Council for other health professions. Ministry of Health Royal Medical Services Professional Health and Medical Associations Educational Hospitals The Health Profession and Institution Licensing Directorate at the MOH.

18 License Renewal Process Licensed Health Professional Health professional participates in CPD activities during five years. Health professional fulfills the license renewal requirements. Records of licensed professionals are kept by related entities and published on their websites. Ministry of Health renews license valid throughout the five years.

19 What if health professionals fail to renew their license? Failing to renew the license within five years is considered a violation of the provisions of the bylaw and health professionals shall be notified to complete the requirements within a maximum period of six months. If requirements are not fulfilled after the expiration of that period, health professionals shall be suspended and reported to the related association.

20 Legislations and Policies Related to Pharmaceuticals

21 Legislations and Policies Related to Pharmaceuticals Laws and Regulations: Public Health Law No. 47 of year 2008 Drug and Pharmacy Law No. 12 of year 2013 Jordan Food and Drug Administration Law No. 41 of year 2008 Narcotics and Psychotropic Substances Control Law Clinical Studies Law No. 2 of year 2011 Joint Procurement Bylaw No.91 of year 2002

22 Legislations and Policies Related to Pharmaceuticals Jordan aims to ensure availability of essential medicines. This is of particular significance recently after increased stress on the health and pharmaceutical sector as a result of the Iraqi and Syrian refugee crisis. Jordan has upgraded its legislations, and went through a pharmaceutical policy reform in 2003.

23 Legislations and Policies Related to Pharmaceuticals The Jordan Food & Drugs Administration (JFDA) was established in 2003 under JFDA Provisional Law No. 31 of year 2003 Currently: JFDA Law No. 41 of year 2008 JFDA ensures Efficacy, Safety and Quality to approve any new drug.

24 Legislations and Policies Related to Pharmaceuticals Proof of Quality Proof of Safety Proof of Efficacy Physico-chemical Tests Biological Tests Microbiological Tests Pharmacological Tests Toxicological Tests Clinical Trials

25 Legislations and Policies Related to Pharmaceuticals JFDA main responsibility: 1. Drug Registration. 2. Drug Pricing. 3. Promoting Rational Drug Use (RDU). 4. Post Marketing Surveillance, including QC and Inspections. 5. Licensing of pharmaceutical manufacturers, importers and wholesalers.

26 Legislations and Policies Related to Pharmaceuticals In order to market any drug in Jordan: 1. The drug should be registered. 2. The drug should be priced. 3. The drug should receive approval on its manufacturing site. 4. The drug cannot be registered unless it goes through lab analysis.

27 Legislations and Policies Related to Pharmaceuticals JFDA Main Directorates : 1. Drug Directorate. 2. Food Directorate. 3. Quality Control Laboratory. 4. Medical Devices & Cosmetics Directorates.

28 Legislations and Policies Related to Pharmaceuticals Drug Directorate issues its decisions throughout its working committees consisting of highly qualified experts from both public and private sectors.

29 Drug Registration The registration application should be submitted by the concerned pharmacist in the drug store or by the technical manager of the local factory. Registration file / Common Technical Dossier (CTD) / an international agreed upon format by the regulatory authorities (ICH regions, that s the US, Europe and Japan).

30 Drug Registration Required documents in each file differ depending on type of product. Registration of a new drug must be completed in less than 180 working days. The average registration time is around 90 days. The price for registration is JOD1,500 for a new chemical entity, and JOD400 for a generic drug.

31 Drug Registration Process

32 Drug Pricing Originators: The pricing criteria uses a range of methods to calculate the price and the one that provides the lowest price is then adopted: - Selling price at country of origin (adjusted to local margins). - Median price based in a country basket (at least 3 countries). - The Saudi Arabia price, where the drug is registered. - If there are no reference prices, then the price of available similar in use products, if any, and the extent to which Jordanian patients can benefit from the introduction of a new drug (cost effectiveness) are considered.

33 Drug Pricing Generics (local & imported): The price ceiling is set not exceeding 80% of the originator price. In general prices of generics in Jordan are high as compared to free market prices for generics in other countries, but this serves as an incentive for achieving higher revenue in exports markets, since most countries consider the country of origin price as a reference.

34 Inspection and QC Carry inspections to ensure the quality, safety and effectiveness of drugs. Ensure proper implementation of laws and regulations related to the manufacture and distribution of drugs. Carry inspections (at least twice yearly) at manufacturers, wholesalers and retail pharmacies. Conduct investigations in response to complaints.

35 Pharmacovigilance Unit Pharmacovigilance (PV) unit works on collecting, monitoring, researching, assessing and evaluating information from healthcare providers, patients and local and international PV centers on the adverse effects of drugs & medical devices to: 1. Identify new information about hazards associated with drugs. 2. Prevent harm to patients. There are 5 regional PV centers that report and share adverse drug reactions with the JFDA and exchange reports with the WHO center in Uppsala, Sweden.

36 Public-Sector Supply Chain for Medicines

37 Rational Drug Use (RDU) RDU at the JFDA undertakes the following activities: Issue and update the Jordan Rational Drug List (RDL). Promote the concept of RDU. The Rational Drug List ensures that the patients receive drugs appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time, and at the lowest cost.

38 Selection Efficiency, safety, and cost benefit analysis is used to guide drug selection. JFDA/ Rational Drug Use (RDU) committees develop standard treatment guidelines and protocols. JFDA and the National Steering Committee which consists for all stakeholders is responsible for issuing and updating the Rational Drug List (RDL).

39 Procurement In 2005 The Joint Procurement Department (JPD) was created with the objective of improving the efficiency of the procurement process in the public sector. JPD is responsible for the procurement on behalf of MOH, RMS, official Jordanian Universities Hospitals, Prince Hamza Hospital and The King Hussein Cancer Center. Ideally 3 bids are required. If there are no qualified bidders (e.g. sole registered drugs in their therapeutic category), JPD executes an additional request of quotation or a direct purchase.

40 Procurement The approximate split for the drugs procured by JPD is around 60% of purchases originators; 30% local generics; and 10% imported generics. In the event of a stock-out, there is a small budget of JOD for urgent procurement directly by the purchasing committee at the MOH.

41 Procurement Process Source: Parkes & Bader 2008

42 Distribution Each of the JPD partners is responsible for the storage and distribution of their procured drugs. The MOH supply and purchasing Department is primarily responsible for distribution to MOH facilities and centers. MOH has 3 main warehouses that distribute to 14 Health Districts, one in Amman and two smaller ones in the north and south. The supply and purchasing Department uses its trucks for distribution, supplemented by sub-contracted transport capacity when needed.

43 Delivery Dispensing of pharmaceuticals is carried out at most public health facilities with a modest co-payment scheme. There are frequent stock-outs for some drugs in the public sector, which are consequentially purchased at retail private sector pharmacies.

44 Private-Sector Supply Chain for Medicines

45 Private-Sector Around 33% of the healthcare provided in Jordan is obtained in the private sector. There are 58 private hospitals with a total of 3642 hospital beds (33%). Patients seeking treatment in the private sector purchase their drugs directly form private retail pharmacies (13% of people have private insurance). In addition those patients who are unable to fill their prescription drugs in the public sector due to stock outs also obtain medicines in the private sector retail pharmacies.

46 Local manufacturing There are 16 Jordanian manufacturers producing mostly generic and branded generic drugs. All registered manufacturing companies are GMP certified according to WHO regulations, 7 hold EMA certifications. Jordan has solid local manufacturing sector which manufacture most generic drugs, yet mostly export oriented, around 70% of their production sold in 65 countries. In Jordan all manufacturers, wholesalers, importers and retail pharmacies must be registered with the JFDA.

47 Importers/Wholesalers There are 84 drug agents and around 160 subagents herbal/ food supplement products importers. All registered companies at the JFDA as wholesalers and importers are required to have suitable storage facilities in which the pharmaceutical products can be stored before distribution. All pharmaceutical products imported into Jordan should be declared to the JFDA and an approval of the pro-forma invoice is required.

48 Pharmacists and Retail Pharmacies There are 2100 registered pharmacies, out of which 1129 are located in Amman. In 2005 chain pharmacy concept have started operating in Jordan. The markup for retail pharmacies is 20% over wholesale price.

49 Mark-up assessment for the private sector supply chain Supply Chain Margins in EU member states Source: Alliance Unichem

50 Medicines and Taxation

51 Key advocacy approaches Involving leaders Building partnership Mobilizing the community groups Capacity building Working with mass media

52 Involving leaders Leaders refer to those who are extremely influential in facilitating changes in national issues of population and health. Law makers: Those who make laws Policy makers: Those who make policies Decision makers: Those who implement policies

53 Thanks to all