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Public Procurement of Essential Drugs in Ecuador
| 작성자 | 관리자 | 카테고리 | 전문가 인사이트 |
|---|---|---|---|
| 작성일 | 2016-06-08 | 조회수 | 2,302 |
| 원문 | |||
| 출처 | |||
Public Procurement of Essential Drugs
in Ecuador
- 글 Anastasia Kozlova
(아나스타샤 코즐로바) - 前 KHIDI 해외제약전문가
상임 컨설턴트
컨설팅 분야
- 중남미지역 의약품 해외수출 전략, 글로벌 마케팅, 인허가 등
- 파트너링 및 수출 계약
- 의약품 전략적 제휴 관리(Alliance Management)
주요 약력
- 前 한국보건산업진흥원 해외제약전문가
- 엔파마(에콰도르의약품구매공사) 대외협력/국제협력 팀장
- 엔파마 대회협력/국제협력 연구원
- 에콰도르 제약분야 전문컨설팅
Identifying the optimal resource allocation for the health sector still remains a key challenge for health care systems in the world.
Economic growths in health care sector and needs to cut down the expensesare multifacetedoutcomes of the increasing nature of the disease burden, the broad range of new treatments,and likewise, inflationand currency exchange rates. The budgetary impacts would always trigger the health systems to balancethe cost-effectiveness and affordability constituents of the technical financial analysisin order to procure the rational usage of health-care resources with the help of innovative and competitive procurement tools and more sophisticated technologies.
Economic growths in health care sector and needs to cut down the expensesare multifacetedoutcomes of the increasing nature of the disease burden, the broad range of new treatments,and likewise, inflationand currency exchange rates. The budgetary impacts would always trigger the health systems to balancethe cost-effectiveness and affordability constituents of the technical financial analysisin order to procure the rational usage of health-care resources with the help of innovative and competitive procurement tools and more sophisticated technologies.
Corporate Reverse Drug Biddings, or known as well as Reverse Auctions for Medicines is a usual practice across Latin American region and the compelling response to the Essential Drug country’s demands. With time, as the essential drug lists started to increase the number of therapeutic lines for the diseases those found responsible for the country’s morbidity patterns, the governments were forced to elaborate more complex and technical applications for web procurement management in order to save health care budgets, to disrupt the potential collusions among the pharmaceutical providers and guarantee the quality, safety and efficacy of the medicinal products acquired that way.
As a constructive solution, health governing bodies were supposed to project the considerably higher funding for the state procurement, to improve the e-procurement systems and finally, to find the way to lower the cost of the drugs to the public healthcare systems.
Further, increasing public expenditures allocated to health sector among LATAM countries resulted in introducing a number of relevant policies to guarantee the effective budget application. According to BMI reports, South America’s spending on pharmaceuticals from 2014 to 2015 represented 0,83% to 1, 6% of its’ GDP and reaching 13 % to 15,5% of the total health expenditure.Even though, aiming to save as much for the State, thepublic procurement is considered to constitute from 15% to 20% of the total GDP of the country.
Such segment remains a very important aspect of State’s fiscal resources.
Such segment remains a very important aspect of State’s fiscal resources.
Methodologies and web portals for e-procurement are remarkably improved and more palpable today in the efficiency and transparency of the contract processes. Colossal efforts had been put forward by the LATAM governments to implement the special schemes for public procurement and to introduce beneficial incentives to stimulate the local manufacturers, as it could be exemplified in the Ecuadorian current drug biddings process.
The Essential Drug List of Ecuador (in Spanish: Cuadro Nacional de MedicamentosBasicos, CNMB) is revised biannually and currently comprises of 399 active ingredients and 727 pharmaceutical forms and concentrations. The National Board of Health (in Spanish: CONASA) called for the 10th revision of the Essential Drug List in 2015 in order to evaluate the feasibility of introducing new drugs for the pathologies that mostly affect the patients in Ecuador or excluding those, lacking the clinical effectiveness and cost- effectiveness in treatments.
The Ecuadorian state market operates through mechanisms of National Service for Public Procurement (SERCOP, before INCOP), such as Corporate Reverse Drug Bidding(SICM) which is intended to supply the lowest cost essential drugs for the population of Ecuador.The first SICMdates back to 2011. The contractual process at that time received numerous observations from Controller General of Ecuador giving details on overpriced drugs and almost exclusive rights for national providers.
Due to insufficiency in the integral planification and evaluation of drug demand in all State health units after the SICM 2011, the Integral Public Health Network (in Spanish: Red Publica Integral de Salud, RPIS)extended the agreements with providers for medicine supplyfor various years more after its termination in 2013 that led to the shortage of necessary medicinesin Ecuadorian Institute for Social Security (in Spanish: Instituto Ecuatoriano de Seguridad Social, IESS) to declare the state of emergencyand great number of health units belonging to Ministry of Health were passing through analogous stock outs. Evidently, there were no any Corporate Biddings held up to 2015.
However, at that time already existed a governmentalproject, a State Pharmaceutical Company ENFARMA EP, which imparted various “privileged” competencies enabling to enter into direct contracting procedures with international providers of pharmaceutical drugs, for those not manufactured on the national territory.
Nonetheless, after set of adverse events, on February the 1st2016, ENFARMA EP was prohibited to conduct the importing of pharmaceutical goods by the presidential Decree №900.On 24th of May, 2016,the President Rafael Correa during his Report to the Nation pronounced his concluding word regarding ENFARMA EP’s finalization of operations and absolute liquidation of the company. Definitely, all competencies of this company would be distributed among the state entitiesin line with the specific area.
The new system software for e-procurementpriced with 3ml USD dollars for the Government of Ecuador included constructive changes in invitation for SICM 2015 in comparison with SICM 2011, with the aim to guarantee the greater competition, methodology to remove the bureaucratic barriers for participation and the technological platform to ensure the transparency of the process.
In the same manner, the procurement process will develop an electronic system with zero policy papers, for greater flexibility, efficiency and transparency. Additionally, a continuous support for pharma providers will be held throughout the SICM 2015.
Corporate Reverse Drug Biddings(SICM 2015) was presented officially by the National Public Procurement Service (SERCOP) onJanuary 14th of 2016. According to Santiago Vasquez, Director of SERCOP, the virtual platform of the auction included 425 drugs that were part of the process. And the State planned to invest USD 500 million, and the savings were expected to reachUSD 110 million and the procurementwould supply for two years all units of the RPIS (Ministry of Health, IESS, Social Security Police and Social Security Armed Forces).
With the entry of economic offers,the Corporate Reverse Drug Biddings (SICM 2015) commenced on February 15, 2016. According to the SERCOP, the virtual platform Ushay, primarily had registered 140 suppliers, 60% of national origin. Within three days of bids, the SICM 2015 yielded the following tangible results: 355 acquired medicines with saving equal to USD 240 ml dollars. During the first phase of SICM 2015 were awarded 63 (41 Ecuadorian) companies out of 160 overall participants that represented 90% national and 10 international. The designed bids permitted to compete 40 companies per one process.
Ministry of Industries attempted to apply a new formula, equivalent to 17,5% for calculating the preferential margin for national manufacturers that would achieve a macro -fiscal balance and permit to maximize the national employment protection and preventforeign exchange outflow. As a result of SICM 2011, as stated in 19 recommendation of General Controller of Ecuador, the drugs offered by domestic suppliers in 2011 took advantage of almost exclusivity that caused an increase in imports and contributed to dramatically de-escalate the operation of installed manufacturing capacity of Ecuador. As declared by SERCOP, the imports of drugs increased from USD 953 million dollars in 2011 to USD 1,077 billion in 2015 due to such a gaffe in leading the state biddings. In this light, a preference marginisapplied only for those companies that are listed in the Register for Producers of Pharmaceutical Industry controlled by the Ministry of Industries (MIPRO), 10% is “by default” for companies that are part of the record, 5% is a proportional amount according to VAE (Ecuadorian Value Added)in SRI (Internal Taxes Service) and 2.5% is proportional according to the value of exports each company displayed. Eventually, such preferential margin is seeking to encourage domestic industry and to foster participation in public procurement.
How preference works? Ecuador industry got the preference margin, this means that in every bid of the whole drug procurement process, Ecuadorian manufacturer will always have preference of 17.5%, more competitive than the international price. Hence, if the international provider offers a product that is 16% cheaper, the national product, in it’s turn, can fix the price higher, i.e. 17.5% more expensive. It is totally more competitive formulawhich benefits the national industry in relation to international one in accordance with the well-thought out interinstitutional concept headed by SERCOP.
It should be emphasized here that prior the offer submission, the international supplier must have a residence or permanent establishment or an agent or representative domiciled in Ecuador and if the drug is awarded, the necessary regulatory documentation must be presented afterwards. One of the essential documents is theMarketing Authorization Certificate issued by ARCSA, National Agency for Regulation, Control and Sanitary Surveillance.
On 17 of May, 2016 the launch of second phase of Corporate Reverse Drug Bidding was announced. By this process, the State expects to acquire more than 90% of the CNMB for the RPIS. At this new stage, there are 297 drugs on the agenda, 211 international and 86 orphan drugs covering 91.7% of the Essential Drug List of Ecuador (CNMB). The new list of medicines to be acquired comprises biological, oncological and other drugs, used in the treatment of rare and catastrophic conditions.
Within the framework of the second phase of the Reverse Bidding, SERCOP together with all members of RPIS, ratified the commitment of the Ecuadorian State to guarantee the access to quality, safe and effectivemedicines, and not only the competitive price.
The process is expected to be published in June 2016, which will start with the pre-contractual phase, and will includes alike bids, negotiations and documentation submission for medicines presented during the bidding process.
Today Latin American region identifies the economic and social effects that can have public procurement, highlighting the process of modernization and development models of the countries of the region. It is clear that each country faces unequaland peculiar challenges that have assumed such systems within different regional and subregional integration. It is undisputable to stressthe real paragon of virtues thatpublic procurement systemscould play, being the instruments of induction of structural changes, value added, competitiveness and technological innovation for developing countries.
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