Challenges 11-Nov-19Facing the National Procurement System- SyriaWCO –SYRIA OFFICE

11 November 2019 1

Agenda

1- Map of Syria.

2- Overview of the national pharmaceutical capacity.

3- Challenges facing the Syrian Health system.

3- Challenges facing the country office.

11 November 2019 2

11 November 2019 3

The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoeveron the part of the World Health Organization concerning the legal status of any country,territory, city or area or of its authorities,or concerning the delimitation of its frontiers or boundaries.Dotted and dashed lines on maps represent approximate border linesfor which there may not yet be full agreement.

11 November 2019 4

Overview of the national Pharmaceutical capacity More than 90% of medicines in the Syrian Arab Republic were locally produced before the unrest began in February 2011. Since then, economic sanctions, currency fluctuations, difficulty in the availability of hard currency and an increase in operational costs have negatively affected the production of medicines and pharmaceutical products.

11 November 2019 5

Challenges facing the Syrian Health system 1. Effects of embargo

2. Difficulties in importing medicines not locally produced such as anti -cancer medicines, factor VIII, hormones, specific antibiotics , and other specific medicines.

11 November 2019 6

3. Reduction of budget and funds allocated by government for procurement of medicines not locally produced.

4. Unavailability of medical and laboratory supplies and spare parts which negatively affected the functionality of medical equipment and the provision of health care services.

11 November 2019 7

Effects of the embargo

Direct Effect

Indirect Effect

11 November 2019 8

Direct Effect

1- Sanctions over the country affected the commercial transactions with banks and was the main barrier that prevented the pharmaceutical companies from exporting medicines to the country.

2- Moreover, the closure of Syrian airport hindered the shipping process of medicines and supplies which also affected importing specific medicines not locally produced.

11 November 2019 9

Indirect Effect

3- Suppliers and manufacturers are reluctant to do

commercial business works in the country to avoid

legal risks they might face in their home country.

4- Interruption of the maintenance services and spare

parts which affected the functionality of

manufacturing equipment.

11 November 2019 10

In Syria “Pharamax” which is the Pharmaceutical Trade Company in the country is trying to search for alternative medicines from “Iran” and “India”.

11 November 2019 11

Difficulties in importing medicines not locally produced such as anti -cancer medicines, factor VIII, hormones, specific antibiotics , and other specific medicines. As a result, available quantities of medicines is limited, hence not sufficient for all population in need.

11 November 2019 12

Examples of medicines and medical supplies affected by “ Sanctions” 1-“Radioactive isotopes” needed for radiotherapy treatment for cancer patients; the country has no other available alternatives to be used for similar indication.

2- USP Reference Standards from the American, British, and European associations of Pharmacopeia which are used to demonstrate identity, strength, purity, and quality for medicines, dietary supplements, and food ingredients.

11 November 2019 13

Upon manufacturing a medicine and before releasing it in the market , the pharmaceutical manufacturer must submit the certificate of Good Manufacturing Practice( GMP)

The proposed medicines will be sent to the quality control laboratories to be tested and eligible to be used in the market.

Examples of quality control measures on locally produced medicines

11 November 2019 14

For specific medicines such as Hormones, Cardiovascular, injectable, Serum, Eye drops , Mental health medicines and other medicines that will be exported to other countries such as Libya, Iraq, Yemen, Somalia, and other countries in Africa, the MOH will request samples of the potential medicines from each “Batch of the Product” to be tested. According to the results , the manufacturer will be authorized to trade the relevant pharmaceutical products.

11 November 2019 15

Unfortunately, the locally manufactured medicines are not yet prequalified by WHO, since the prerequisites are very strict and expensive.

11 November 2019 16

Challenges facing the country office

Making essential medicines and supplies available in the country. WHO procures medicines, certified from GMP sources in Europe, North Africa, Asia and others, according to generic names and not brands.

11 November 2019 17

The sanctions and its impact is obvious on medical supplies. For example, most of the requested lab test kits and consumables which are usually requested by the Public Health Labs are required from manufacturers who reject purchases order for Syria due to the U.S. embargo, such as SIGMA, Gilson

11 November 2019 18

Another exampleWHO had been importing Anaesthesia Machine and Monitor/Draeger Fabius Plus 860800 – CoO: Germany. However, as a part of this device, some accessories such as EtCO2 Module Opto-electronic gas sensor for measuring concentrations of carbon dioxide require an End User Certificate for the US government to approve exporting these items. The license and approval takes several months.

11 November 2019 19

11 November 2019 20