Findings
Overall availability of the five cardiovascular medicines was low, with an average availability of 57.3% in the private sector and 26.3% in the public sector. However, availabilities of over 80% were observed in some countries (public and/or private sector). Availability of the lowest-priced generics was higher than originator brand products in most surveys and private sector availability was higher than public sector availability in all surveys. However, even in the private sector availability was not universal and prices were nearly always higher. In general, higher income countries had higher medicine availability than lower income countries, both in the public and private sector. Differences in the presence of CVD medicines on National Essential medicines lists, where they exist, may explain the (poor) availability of medicines in some countries. For example, in some countries enalapril was chosen as an essential ACE-inhibitor rather than captopril which was surveyed [23].
Average public sector procurement prices were relatively high; in the past, a MPR equal to or below 1.0 has been described as a reasonable procurement price [13]. Some countries achieved procurement prices well below the international reference price for a number of medicines, whereas others consistently paid higher prices [24]. As would be expected, generics were procured at lower prices than originator products. When comparing public sector procurement and patient prices, it was seen that in some cases patients were charged less than the procurement price. This could reflect that countries are aware of the high prices for essential chronic disease medicines and are using a cross-subsidizing system to lower these prices. In other cases however, patient prices in the public sector were much higher than procurement prices, which could be due to high mark-ups and taxes along the supply chain.
As with availability, patient prices varied greatly among surveys. In countries in which patients paid for medicines in the public sector, the average cost of LPGs was less than in the private sector for all medicines. However, a lack of availability in the public sector may force patients to purchase their medicines in the more highly priced private sector or forgo treatment altogether. For example, captopril had an adjusted MPR of 0.67 in the public sector in Jordan but only 61% availability. In the private sector, captopril had a much higher availability (90%), but the patient would need to pay 19.02 times the IRP.
As would be expected, generics were priced lower than originator brand products in nearly all surveys for all medicines. Our calculations of brand premiums show that to purchase an originator brand medicine costs 4.2 times as much as buying the lowest-priced generic. Interestingly, brand premiums were on average lower in upper-middle and high income countries. One would hope this smaller price differential was due to lower prices for the originator brand, but unfortunately this was due to higher prices being charged for generic products. This can occur when price regulations set the price for the generics discounted from the price charged for originator brand products, as occurs in Kuwait [13].
Overall, patient prices for cardiovascular medicines were high compared to international reference prices. For LPGs, the average adjusted MPR for the entire group of medicines was 15.5 in the public sector and 30.2 in the private sector.
The affordability data showed that on average one month of chronic treatment with one medicine for hypertension cost 1.8 day's wages. In all cases, originator brand products and the private sector were less affordable. Skipping one or two meals was often not enough to purchase treatment and often more than one day's wages were needed to purchase one month of treatment; therefore cardiovascular medicines may be labelled as unaffordable in a significant proportion of countries. Furthermore, an important part of the patient population requires combination therapy with multiple anti-hypertensives to reach treatment goals, amounting to an unaffordable treatment package. Finally, in one-income families, chronic treatment becomes particularly unaffordable if more than one family member has a medical condition that requires treatment.
Strengths and weaknesses
The strength of this research lies in the standardized WHO/HAI methodology which has been validated through pilot and validation studies and adapted accordingly [17].
However, some difficulties do exist. Outcome measures, in particular availability, may be affected by the exclusion of alternate dosage forms and strengths or therapeutic alternatives. Also, availability data do not reflect average availability over time since availability data is only collected on one specific day. Furthermore, median price ratios may be skewed when international reference prices are based on limited data [18]. For this reason, price data for losartan were not analysed. It is important to realize that the MPR is a relative measure of price and does not provide information on the absolute price of a medicine; thus the absolute price of hydrochlorothiazide may be lower than that of nifedipine even though the latter has a lower MPR.
In some cases, data in one or more income group may have been skewed due to the small number of surveys in that category or dominance of one country within one income group. The latter occurred a number of times with surveys from India, which due to the unique nature of the Indian pharmaceutical market and the large number of Indian surveys, may have influenced outcomes in the low income group.
Calculating affordability based on the wage of the government worker may lead to an over-optimistic result since a significant proportion of the population earns less than this amount [14]. Alternative measures for affordability are currently under investigation [25]. A further problem for the affordability analysis was that only a limited number of surveys calculated affordability of these medicines.
Implications
Based on the outcomes of this analysis, several implications for policy making can be emphasized. The poor availability in the public sector limits patient access to medical treatment by forcing them to resort to the more highly priced private sector, which has better, although not optimal, availability. The public sector is often seen as a last resort, but as our data show, the private sector fails to meet the needs of those least able to afford highly priced products. Improving public sector availability can be achieved by implementing more efficient procurement in the countries that pay high procurement prices, improving distribution systems and providing adequate and sustainable financing. Furthermore, focusing (limited) resources on a selected group of generic essential chronic disease medicines instead of aiming to supply a broad range of generic and originator brand medicines may lead to better availability of priority treatments [15].
In some countries, lowering procurement prices could help bring patient prices down [26]. Strategies to improve procurement efficiency include competitive procurement with price transparency, national pooled purchasing and purchasing by generic name [17]. Differential pricing based on the wealth of countries could also lower prices. This differential pricing already occurs for originator brand products to some degree, but not as much for generic products [27]. Promoting differential pricing could benefit lower income countries, not only affecting medicine prices, but also improving the availability of medicines. Options and strategies for differential pricing are currently being explored and promoted [28, 29].
Addressing excessive mark-ups between procurement and patient prices could help bring prices down. For example in Syria, the maximum percentage mark-up allowed is determined based on the cost of the medicine; more expensive medicines are allotted a relatively lower mark-up to prevent preferential selling of highly priced products [15, 30]. Furthermore, exempting medicines from tariffs and taxes, such as the value-added tax, will lower prices and prevent taxing of the sick [14, 26]. It must then be ensured that savings obtained are passed on to patients. Furthermore, it has been found that in some countries, particularly in Sudan and China, revenue from medicine sales in the public sector is used to finance other parts of the public health care system [15, 31, 32]. Because the public sector is primarily used by the poor, this practice is inequitable and alternative sources of financing should be sought [15].
Furthermore, continuous support for the use of generic products can contribute to keeping the costs of medicines down, both in the public and private sector. Several strategies have been proposed, including ensuring product quality, encouraging or requiring generic substitution, preferential registration procedures and education of health care professionals and consumers [14].
Although generic medicines were usually priced lower and were more available than originator products in the private sector, some were still relatively overpriced as can be seen by the small brand premiums in high income countries [13]. In some cases, this could be prevented by implementing policies that do not regulate generic prices based on the price charged for brand products.
No matter how inexpensive medicines are in the private sector, the poorest sections of population in developing countries will still not be able to afford them. Further, chronic disease treatment requires lifelong therapy in order to prevent potentially life-threatening complications. Such demand is predictable and creates a responsibility on the health care system to ensure continued availability. Health insurance which covers out-patient chronic disease medicines is therefore of key importance. In this line of reasoning, investing in expensive facilities such as stroke or cardiac care units should only occur when reliable access to hypertensive medicines has been achieved.