Abstract
The objective of this study was to compare the availability and prices of locally produced and imported medicines, in particular after one year from medicines importation restriction and to answer the key questions, did local manufacturers able to coverage national needs of medicines and what is the patient prices for locally produced compared to imported medicines in different sectors and regions of Sudan.
The WHO/HAI methodology survey tool was adapted to measure the availability and price of locally produced and imported medicines. Patient price and availability were collected from capital cities of 6 states as per WHO/HAI methodology. Data were collected and analyzed for 50 medicines from the 104 medicines restricted to local manufacturer. Availability was based on whether the medicine was in stock on the day of data collection at the surveyed facility. Prices were expressed as median price ratio (MPR).
Availability of locally manufactured medicines (LMM) was much better than imported medicines (IM), in the public, (47.2% vs. 14%, respectively) and private (63.9% vs. 23.5%, respectively) sectors. Based on median price ratio (MPR), public sector patient prices for locally manufactured medicines were lowered priced and had a median MPR of 2.4 (n=42) than imported medicines which had a median MPR of 4.99 (n=20). In private sector patient prices for locally manufactured medicines were also lowered priced and had a median MPR of 2.76 (n=45) than imported medicines which had a median MPR of 5.53 (n=27). Thus; patients were paying about 52% less for locally produced than for imported medicines in both sectors
The survey showed low availability of the basket of medicines surveyed in the public and private sectors for imported medicines (I.M), while not achieving WHO s target of 80 % for locally manufactured medicines (LMM). In developing countries a lot of barriers are well known to business and industrial need to be resolved in order to maintain availability and self-reliance in drug production as a mean of increasing access to medicines.
Author Contributions
Copyright© 2020
I. Khder Salah, et al.
License
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Competing interests The authors have declared that no competing interests exist.
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Introduction
Drugs are often the most important cost of health care expenditure in management process of diseases. Patients that have access to adequate and effective drugs at the time of need are most likely to be happy with treatment they receive. The availability of affordable and effective drugs is, therefore, one the most visible indicators of the quality of health services. Despite significant progress in increasing access to essential medicines in low-and middle income countries during the past decades, many o the health services still lack adequate supplies of basic medicines. Drug shortage and quality problems continue to undermine the performance of health systems through the developing world. Increasingly government is supporting local medicine production, expecting that it will result in increased availability and lower prices, as well as industrial and economic benefits. The objective of this study was to compare the availability and prices of locally produced and imported medicines, in particular after one year from medicines importation restriction and to answer the key questions, did local manufacturers able to coverage national needs of medicines and what is the patient prices for locally produced compared to imported medicines in different sectors and regions of Sudan?. The WHO/HAI methodology survey tool was adopted with some variations in terms of identification of surveyed medicines by substituting generic and branded medicines with locally produced and imported medicines, to measure their availability and price in order to answer the study questions. For better understanding availability and prices of selected medicines were collected from different regions in Sudan. The data obtained were analyzed and compared and presented as results from public and private sectors and discussed in details in the forthcoming sections. Such studies provide valuable advocacy messages for policymakers, pharmaceutical industries, regulators, prescribers and patients if well shared and delivered in a timely manner.
Results
In the public outlets surveyed, locally manufactured medicines (LMM) was more predominant than imported medicines (IM), but in general the mean percentage availability of all surveyed medicines in the public sector was low at 14.0% for (IM) and 47.2% for (LMM). There was a big variation in mean availability among the regions surveyed. The lowest for IMs availability was seen in Port-Sudan city (Eastern State) at 2.0% and for LMMs was seen in Wadmadni city (Gezera State) at 32.0%. Availability for IMs was highest in the Peripheral of Khartoum city (Capital State) at 29.6% and for LMMs was highest in S. Kordfan (Western state) at 62.4%. Public sector patient prices for locally manufactured medicines were lowered priced than imported medicines and had a median MPR of 2.4 (n=42) while imported medicines had a median MPR of 4.99 (n=20). The median brand premium was 2.3 (meaning that, on average, IM were about 2.3 times the price of LMM). Hence patients were paying about 107% times the price of the LMM (on average) more when being dispensed as imported products in public sector. Twenty (20) matched pairs of medicines were found for comparison between imported medicines and locally manufactured medicines equivalents. The MPRs for IMs and LMM are shown in Again local manufactured medicines availability in the private outlets surveyed was higher than in the imported Medicines, with better availability in private sector than public sector. The mean availability of LMM was (63.9%) and for IM was (23.5%). Mean availability varied across the 6 regions surveyed. The lowest availability was also seen in Port-Sudan city (Eastern State) at (4.8%) and for LMMs in Wadmadni city (Gezera State) at (54.7%). Also Availability for IMs was highest in the Peripheral of Khartoum city (Capital State) at 40.0% and for LMMs was highest in S. Kordfan (Western state) at (79.5%). For individual medicines ( Private sector patient prices for locally manufactured medicines were lowered priced and had a median MPR of 2.76 (n=45) than imported medicines which had a median MPR of 5.53 (n=27). The median brand premium was about 1.95 (meaning that, on average, IM were about two times the price of LMM). Hence patients were paying about 95% times the price of the LMM (on average) more when being dispensed as imported products in private sector. Twenty seven (27) matched pairs of medicines were found for comparison between imported medicines and locally manufactured medicines equivalents. The MPRs for IMs and LMM are shown in The regional comparison for LMM showed that Khartoum Peripheral had the lowest median MPR for (2.11), while they were highest in the Wadmadni city (3.56). The 25th and 75th percentiles were 1.85 and 5.11 respectively. For IM; the lowest median MPR also in Khartoum Peripheral (3.48); while the highest in Khartoum central (5.34). The 25th and 75th percentiles were 2.89 and 9.3 respectively, indicating a larger variation across the pharmacies compared to LMM. Across 20 medicines paired analysis patients paying more in private sector by 4.6% than public sector for imported medicines. However, across 42 medicines paired analysis patients paying more for locally imported medicines in private sector by 14.8 % than public sector. This percentage difference between private to public varies among regions for different paired items and it reaches up to 27.8% for imported medicines in peripheral of Khartoum and 41.5% for locally manufactured medicines in Wadmadni city
Amoxicillin Suspension, Ampicillin + Cloxacillin, Atenolol, Cephalexin, Cotrimoxazole tab, Hyoscine, Ibuprofen, Praziquantel, Quitapine Fumerate, Quinine Sulphate,
Atorvastatin + Amlodipine,
Acetyl Salicylic Acid, Albendazole, Alu. hydroxide + Mg, Trisilicate, Atorvastatin + Amlodipine, Chlorophinamine, Co-trimoxazole suspension, Diazepam, Loperamide, Metronidazole Suspension, Metronidazole, Paracetamol Suspension, Paracetamol + Caffeine, Paracetamol tab, Pyridoxine Hcl, Resperidone, Salbutamol , Sildenafil, Tetracycline ,Valsartan Hydrochlorthiazide.
Albendazole, Diazepam, Quitapine Fumerate, Resperidone, Sildenafil Citrate, Valsartan Hydrochloride
Atorvastatin, BisprololFumerate, Esomeprazole, Furosemide, Glibenclamide, Paracetamol + Chlorzoxazone .
Alu. Hydroxide + Mg. Trisilicate,
Amoxicillin, Azithromycin, Azithromycin Dry Powder, Candesartan Cilextil + Hydrochlorothiazide, Cefixime Caps, Ciprofloxacin, Ranitidine.
Candesartan Cilextil + Hydrochlorothiazide,
Amlodipine, Candesartan Cilextil, Cefixime Dry Powder, Cough Syrup (Any formula), Lisinopril, Metformin.
Azithromycin Dry Powder, Co-trimoxazole Suspension, Co-trimoxazole tabs, Esomeprazole, Lopermide, Paracetamol + Caffiene, Paracetamol + Chlorzoxazone, Quinine Sulfate, Salbutamol.
Diclofenac, Omeprazole,
Ampicillin + Cloxacillin, Candesartan Cilextil, Furosemide, Glibenclamide, Metronidazole, Praziquantel, Ranitidine, Tetracycline.
-
Amoxicillin, Atenolol, Azithromycin, Cefixime caps, Cephalexin, Diclofenac, Ibuprofen, Lisinopril, Omeprazole, Paracetamol.
-
Chlorphenarmine maleate, Ciprofloxacin, Hyoscin, Metformin, Paracetamol Tabs,
-
Acetyl Salicylic Acid, Atorvastatin, BisprololFumerate, Cough Syrup (Any formula), Metronidazole Suspension
-
Amlodipine.
-
-
Amoxicillin Suspension , Atenolol, Atorvastatin + amlodipine, Chlorphenarmine maleate, Co-trimoxazole tabs, Hyoscin, Resperidone.
Ampicillin + Cloxacillin, Cephalexin, Co-trimoxazole Suspension, Ibuprofen, Lopermide, Paracetamol + Caffiene, Paracetamol + chlorzoxazone , Paracetamol Tabs, Praziquantel, QuitapineFumerate, Quinine Sulfate.
Quitapine fumerate.
Albendazole, Diazepam, Furosemide, Glibenclamide, Metronidazole Suspension, Metronidazole, Ranitidine, Salbutamol, Sildenafil Citrate, Tetracycline, Valsartan/Hydrochlorthiazide.
Atorvastatin + Amlodipine, Resperidone, Valsartan/Hydrochlorthiazide
Acetyl Salicylic Acid, Alu. Hydroxide + Mg Trisilicate, Amoxicillin, BisprololFumerate, Esomeprazole, Paracetamol, Pyridoxine Hcl.
Diazepam.
Azithromycin Dry Powder, Cough Syrup (Any formula).
Albendazole, Paracetamol + Chlorzoxazone,
Pyridoxine Hcl, Quinine Sulfate, Sildenafil Citrate.
Atorvastatin , Azithromycin, Cefixime Caps, Ciprofloxacin.
Candesartan Cilextil + Hydrochlorothiazide.
Candesartan Cilextil + Hydrochlorothiazide, Cefixime Dry Powder, Diclofenac
Alu. Hydroxide + Mg. Trisilicate, Azithromycin Dry Powder, Co-trimoxazole Tabs, Diclofenac,
Paracetamol + Caffiene, Praziquantil.
Candestan Cilextil, Lisinopril, Metformin,
Amlodipine, Ampicillin + Cloxacillin, Cephalexin, Chlorophenarmine maleate, Cough Syrup (Any formula), Esomeprazole, Furosemide, Glibenclamide, Lisinopril, Metronidazole, Omeprazole, Salbutamol, Tetracycline.
Omeprazole .
Azithromycin, Candesartan Cilextil, Hyoscin, Loperamide, Metformin,
Amlodipine.
Acetyl Salicylic Acid, Amoxicillin, Amoxicillin suspension, Atorvastatin, Cefixime, Ciprofloxacin, Co-trimoxazole suspension, Ibuprofen, Metronidazole Suspension, Paracetamol, Paracetamol Tabs, Ranitidine,
-
Atenolol, Bisprololfumerate, Cefixime caps,
Public
Private
IM
LMM
IM
LMM
% diff private to public IM
% diff private to public LMM
Patient
Number of paired medicines
20
42
27
45
Prices
Median MPR
4.9
2.4
5.35
2.76
4.6%
14.8%
Median interquartile range (IQR) or (The 25th and 75th percentiles)
2.94-8.53
1.52-4.02
2.89-9.3
1.85-5.11
Min MPR
0.91
0.33
0.76
0.47
Max MPR
49.81
16.67
65.01
27.57
Region
Median MPR Khartoum Centeral
1.99
5.26
5.34
2.32
7.1%
12.3%
Prices
Median MPR Khartoum peripheral
1.77
4.73
3.48
2.11
27.8%
10.0%
Median MPR Wadmadni
2.73
N.P*
8.44
3.56
-
41.5%
Median MPR Obid
1.78
N.P*
6.28
2.68
-
30.1%
Median MPR S. Kordfan
2.22
4.89
3.98
2.61
0.0%
1.4%
Median MPR Port-Sudan
4.01
N.P*
N.P*
3.13
-
0.0%
Discussion
One of the suggested pathways towards the removal of barriers to quality drugs is the development, or strengthening, of local production systems. Other objectives for industrial policy of local production: the desire to develop a local employment base; the need to increase technology transfer; the wish to become 'self sufficient' in medicines; the need to reduce reliance on imports and manage foreign exchange flow; and the desire to produce medicines for export. The survey showed low availability of the basket of medicines surveyed in the public and private sectors for imported medicines (I.M), while not achieving WHO s target of 80 % for locally manufactured medicines (LMM). In the public sector outlets, locally produced products were far more commonly stocked than imported products (47.2% compared to 14%). In the private sector, outlets tended to stock more locally produced products (63.9%) compared to imported products (23.5%). In all six survey regions the availability of locally produced products was higher than for imported products in the public and private sectors. Similar results were obtained from Ethiopian survey where locally produced medicines are more predominant than imported medicines, while opposite results were obtained from Tanzanian survey, that imported medicines are more available than locally produced medicines. The survey results show that patients are paying significantly more to purchase imported medicines than locally manufactured medicines in all sectors surveyed. While noting the WHO target that consumers should pay no more than four times the IRPs, we observed that medicine prices were higher for imported medicines compared to IRPs in both public and private sector (4.99 and 5.53 respectively). Overall patients were paying 107% more in public sector and 95% more in private sector for imported products compared to locally produced products. Some individual imported medicines were being purchased at very high prices than locally produced ones e.g. Esomeprazole 20 mg cap were dispensed as imported medicines at a price that was 3.5 times than locally produced price in both public and private sectors. Compared to information on medicine prices and availability in general, little is known about the impact of local medicine production on prices and availability in different countries. In many countries, studies found locally produced medicines had lower patient prices compared to imports. Kuanpoth found locally produced ARVs had lower patient prices compared to imported ARVs in Vietnam. The apparent consumer willingness to pay higher prices for imported products, as seen in the public and private sector in Sudan, may reflect a perception that imports are of higher quality. To boost local industries, the government needs to ensure and publicise the equivalent quality of locally produced medicines, also the local pharmaceuticals need to spend more money in promotion and marketing of their products and do not depends only on price difference from imported medicines. Supporting local manufacturers through fiscal and/or non-fiscal incentives must be time-bound, developed and implemented in a transparent way, and should not be implemented suddenly or abruptly otherwise it may unintended had a negative effects on the availability. Balancing local production policies is critically important and information on foreign exchange, exports, imports, job demand and other economic and societal indicators need to be evaluated before and after creating local manufacturing capacity; and before and after changes in industrial and/or pharmaceutical policy with regard to local production of pharmaceuticals. Finally; In-spite of all obstacles facing local production we have to recognize that many advantages of local production for both public health and economic development could be achieved such as improve affordability of quality medicines from known and frequently inspected facilities. It has also the potential to offer other advantages over imports; for example by shortening related supply chains; it can help reduce stock outs and by expanding and diversifying the supply chain, it allows developing countries to secure access in response to growing demands. There is also some evidence that locally manufactured products are more successful in reaching rural populations than imported ones. Strategic and logistic limitations in our research may have affected the findings . Thus, three main limitations arose, firstly; we did not include the procurement sector, and identifying prices and availability of imported and locally produced medicines procured by the government, secondly we were not differentiate between prices and availability of imported medicines by product type (originator brands, branded generics) and thirdly; patient affordability have not been measured furthermore, price components in the supply chain.
Conclusion
In both the private and public sectors, considerable price differences were seen between LMM and IM. In general, IM were almost 2 times more expensive than the LMM.The availability of the surveyed medicines was extremely low in all sectors as imported medicines and better as locally manufactured medicines.The impact of policy changes made should be measured by establishing a monitoring system to monitor not only regularly the prices, but also the availability and affordability of medicines