Patients, experts, and openness: A powerful combination therapy for unaffordable medicines in Moldova
Moldova has some of the highest rates of HIV and tuberculosis in Europe, but the medicines used to treat these conditions are often very expensive or not available. Moldova’s transparent system for purchasing medicines has become an invaluable tool for fighting the country’s longstanding epidemic of communicable diseases like HIV/AIDS, tuberculosis, and hepatitis C and the coronavirus. This open contracting approach is part of a series of medical procurement reforms with an unexpected leader: patients from some of the most vulnerable groups in society who’ve worked with open-minded public health and procurement experts to drive down the cost of drugs without compromising on quality, freeing up funds for other critical preventive and curative care measures. Thanks to this collaboration the country saved 15.4% on medical procurement overall – including 19% saving on HIV medicines – and enabled real-time monitoring of US$60 million worth of medical contracts and medicine supply and delivery to hospitals.
For almost two decades, the patient-run organization Positive Initiative has been fighting to secure affordable, quality treatment for infectious diseases in a highly concentrated market where corruption risks are high.
Since 2018, they’ve become a trusted partner for authorities, leading efforts to make medicine procurement more efficient and competitive. Several user-friendly online platforms allow both authorities and civic actors to track the purchase and roll-out of medicines across the country. Amendments to the centralized medical contracting procedures has reduced the average time between tender announcement and contract signing by two months. Joint efforts have been particularly effective in the HIV/AIDS program, where lower price generics have almost completely replaced expensive brand name medicines, leading to overall savings of 19% on the 2020 HIV/AIDS program procurement budget.
When the COVID-19 pandemic hit, this partnership between civil society and government put Moldova in a better position than most to purchase items efficiently and monitor how emergency funds were spent. A campaign advocating for medicine and COVID-19 procurement transactions to be carried out transparently prompted the government to end an exemption that had allowed medical procurement to bypass Moldova’s state-of-the-art electronic procurement portal MTender and its accountability and oversight mechanisms for several years. With support from the Open Contracting Partnership, a coalition of 30 civil society organizations have used the open contracting data generated by MTender to build a range of user-friendly digital tools for tracking the procurement, roll-out and availability of medical supplies, including COVID-19 vaccines. Civic actors use these platforms to inform patients about the purchasing and availability of medicines while the information helps civil servants to drive better deals with their suppliers.
Between January, 2021, when CAPCS purchases returned to MTender, and the end of October, the central procurement agency successfully completed over 2,533 procurement lots for almost $60 million via the system, with average savings of 15.4% compared to the planned value and an average number of 2.3 bids.
When Constantin Charanovksy decided to beat his drug addiction 11 years ago, he learned he had hepatitis C. The disease is known as the “silent killer” because symptoms often don’t manifest until the liver has been irreparably damaged.
In years prior, Charanovksy’s only hope for a cure would have been to undergo interferon treatments, a therapy so expensive in Moldova that patients would have to sell their apartment or a kidney to afford it. Even then, it was only effective in about 50% of cases and often had adverse side effects.
“It’s difficult to enjoy life when you have those thoughts,” he says.
Moldova was already battling a health crisis long before anyone had heard of COVID-19. The nation of 2.6 million people has some of the highest rates of communicable diseases in Europe. An estimated 14,500 people are living with HIV—almost a third of whom aren’t aware of their diagnosis, over 13,000 have hepatitis C and more than 2,000 have tuberculosis.
Unaffordable medicines can be a death sentence for these patients, who need constant treatment to survive. At the same time, citizens and health experts have complained of drug shortages and inferior medicines in the past, exacerbated by a health sector that has been badly underfunded and immobilized by corruption. As a small country with few local pharmaceutical manufacturers, Moldova relies on imports and is largely at the mercy of distributors. Services and treatment for tuberculosis, Hepatitis C, and HIV/AIDs have depended on assistance from the Global Fund, although Moldova is weaning itself off international aid and state funding now covers the budgets for the latter two conditions.
Fortunately for Charanosky, there was a major breakthrough in hepatitis C treatment in the years following his diagnosis. Two new drugs, sofosbuvir and daclatasvir, were brought to market that were highly effective in curing the disease in a matter of months. In time, the advent of generics made this treatment more affordable. Today, every patient with hepatitis C in Moldova can access medicines for free. So can those with HIV/AIDS and tuberculosis.
Fully recovered, Charanosky is now a board member of the patient-run organization Positive Initiative (Initiativa Pozitiva), where he fights for the rights of people with and at risk of contracting serious infectious diseases to live long and happy lives. Like him, around half of Positive Initiative’s board members have been beneficiaries of the organization’s services.
Since 2018, Positive Initiative has been working with experts in government to foster competition in medicine procurement through a series of reforms: improving the rules and processes that govern the purchase of medicines, expanding access for generic drug makers to the Moldovan market, and enhancing public procurement monitoring with sophisticated, real-time data analysis. The foundation of these changes has been collaboration with actors in Moldova, as well as international experts.
This wasn’t always the case. In the past, Positive Initiative relied on a more confrontational approach, once demonstrating outside the health ministry offices with coffins to raise awareness of the deadly consequences when patients lack adequate treatment. But in the long term, it wasn’t as effective as they might have hoped.
Deciding to change tack, Positive Initiative fostered a constructive dialogue that benefited both sides, becoming not only a watchdog but a reform partner and innovator for government— on the one hand, helping inform patients about the purchasing and availability of medicines and on the other, helping to train civil servants to drive better deals with their suppliers.
A multi-stakeholder partnership between the patient community and government has identified and introduced procurement policies and practices that will stimulate competition in the pharmaceutical market and lead to fairer prices. Not only do these savings ensure all patients can access medicines free-of-charge, the funds can also be reinvested in other activities that are crucial to fighting the epidemic, such as prevention programs that help to curb new infections. For example, $28 that the state saves when procuring medicines can cover the average cost of prevention services for one person vulnerable to HIV.
“We need to conduct procurement as transparently and efficiently as possible, saving more money on medicine procurement to channel it to other budget lines where there’s a deficit,” Charanosky says.
Trends in State Funding for HIV Prevention Program
One of Positive Initiative’s main collaborators in government has been the National Programs, a group of experts in the Ministry of Health, Labor, and Social Protection, who determine treatment protocols and which drugs to procure at the central level each year, based on patients’ needs and recommendations of the World Health Organization (WHO). Working together, they’ve established good practices that are among the most advanced for medicine procurement in Eastern Europe and Central Asia. These activities have led to significant savings on the budget for HIV/AIDS and encouraging savings on the budgets for tuberculosis and hepatitis C.
“The critical task of centralized procurement is to boost competition and facilitate the introduction of generics,” says Charanovsky. “This is not about saving money at the expense of people’s health, this is about optimizing limited resources and saving as many lives as possible. Thanks to the open position and leadership of the National Program team, we are managing to make this change happen.”
A chance for generics
Improving the range of medicines that Moldova purchases has been one of the tactics Positive Initiative and its partners have promoted and used to generate savings. In the past, Moldova’s treatment protocols usually required expensive brand-name drugs. These were often purchased in small quantities and controlled by one importer, which hampered competition and pushed up the price dramatically.
In 2019, Positive Initiative took part in the Open Contracting Partnership’s (OCP) impact accelerator program Lift, through which they analyzed the list of medicines purchased by the government that year to identify lower-cost generic alternatives. They also developed a new collaboration with the central medicine procurement agency CAPCS (short for Center for Centralized Procurement in Healthcare), a unit of the health ministry, responsible for most of the country’s medicine purchases. Working with CAPCS and the National Programs, they set out to improve the medicine procurement processes, using their analysis as a starting point.
The joint team identified the biggest opportunity for reform in the budget for antiretroviral drugs to treat HIV/AIDs. In 2018, the brand-name drug, Aluvia, burned through about 55% of the budget. Thanks to the coordinated efforts of the different actors, in 2020, the National Program managed to reduce the share of Aluvia to 3% of the total procurement value, replacing it with a generic combination drug (tenofovir / lamivudine / dolutegravir) that now accounts for about 50% of the program budget. Moreover, the price of that generic drug dropped by 23% in 2020, leading to savings of 19% on funds allocated for first-line drugs against HIV/AIDS. Despite buying them in comparatively small quantities, some prices for antiretroviral medicines in Moldova are among the lowest in the region, including the generic combination drug which is almost 8% cheaper than in Ukraine, where the quantity and value of the order is nine times as high as Moldova.
“Moldova must be able to update treatment plans in a timely manner in accordance with WHO recommendations, to optimize treatment costs while ensuring that the quality does not suffer. We are very pleased that this is all being done in cooperation and with the support of NGOs and development partners,” says Yuri Klimashevsky, coordinator of the National Program on Prevention and Control for HIV/AIDS and STIs.
Savings on public procurement were as high as 19% in 2021
|Program||Budget||Contract value||Savings||Savings, %|
Early detection to promote competitive tenders
Working as a cross-functional team, Positive Initiative could act quickly and early when this year’s medicine procurement cycle began, flagging issues to National Programs at the tendering stage and creating processes to alert potential suppliers to opportunities.
In Moldova, tenderers can offer a price higher than the expected value, and in the absence of competition in the market, this can lead to disappointing results. This happened during the procurement of medicines for HIV/AIDS and STIs in 2021. When Positive Initiative monitored the procurement order, the first tender produced good prices for most items. However, they noticed one issue: some prices had skyrocketed. The overspend on just three items totaled more than 70% of the entire budget for all antiretroviral drugs and infections in 2021, which was based on previous years’ spending.
Positive Initiative approached the health ministry, expressing its concern and calling for the tender to be readvertised. At the same time, they consulted specialists from CAPCS, the OCP and a Ukrainian patient organization 100% Life.
A further analysis of the prices showed that one of the expensive medicines, Emtricitabine/Tenofovir disoproxil with a dosage of 200 mg/245 mg, has four manufacturers and Moldova only received an offer from one of them. And yet, the drug is available at another dosage of 200 mg/300 mg that has the same effect. It is produced by as many as 12 manufacturers, most of whose products are approved by the WHO or the FDA.
In response, CAPCS amended the terms of reference to add the equivalent dosage of Emtricitabine/Tenofovir disoproxil 200 mg/300 mg and announced the tender again. Positive Initiative, in turn, sent requests to nine potential suppliers of generics, inviting them to participate in the newly announced tender.
This time, the best offer was almost 20 times lower than the initial one, from US$528,000 to just $26,700.
The high price of patents
To promote competition in the procurement of medicines for drug-resistant tuberculosis, Positive Initiative relied on litigation. In line with WHO recommendations, Moldova added a number of new drugs to the list of medicines for centralized procurement in 2020. Among them is bedaquiline, a drug patented under the brand name Sirturo until 2023 in most countries, including Moldova, and potentially far longer if the manufacturer succeeds in gaining what is known as an evergreen patent.
In Moldova, this monopoly led to prices so high that only 23,124 bedaquiline tablets could be purchased with the allocated budget for 2021 instead of 86,000, as previously planned. An existing stockpile of bedaquiline prevented patients from missing out on treatment this year, but Positive Initiative was concerned that high prices would obstruct patients’ access to life-saving medicines in the future. They sued Janssen in April 2021, seeking to invalidate a secondary patent that would extend the company’s monopoly on bedaquiline beyond the current period by an extra five years—until 2028. The case is ongoing as of October.
Share of generic drugs in the cost of programs
** The decrease in the share of generic drugs is associated with the inclusion of patented bedaquiline in the nomenclature
Timing is everything
Positive Initiative has worked with CAPCS to amend some of the outdated procurement rules and practices. In late 2019, with the support of the Ministry of Health, Labor and Social Protection, they optimized the time interval between announcing tenders and signing contracts, reducing it by an average of two months. This reform proved invaluable at the start of the pandemic as Moldova managed to maintain the supply of medicines to patients, avoiding interruptions that were common in many countries.
CAPCS also decided to announce medicine tenders and sign contracts earlier in the year, starting in August. Both these changes were a major focus of the Moldovan team while participating in OCP’s Lift program, where the input of external experts was a huge asset, according to Positive Initative’s Charanosky.
“We found ourselves in a very friendly atmosphere, saturated with advanced international expertise in the field of open contracting, and this experience left an essential imprint on our future work.”
Holistic procurement reform
Moldova has integrated other international good practices across the procurement cycle to conduct medicine procurement more efficiently, with the support of OCP and other organizations.
In September 2020, the health ministry formally amended its regulations outlining the recommended timeline for each centralized medical procurement procedure—from planning through to drug distribution—after Positive Initiative found the prescribed time intervals for various steps were unrealistic—needlessly rushed at times and causing bottlenecks at others—and worked with CAPCS experts to streamline the process. UNDP Moldova supported this project.
To improve the planning phase, CAPCS recently introduced category management—a strategic approach that relies on expertise for specific items to produce high-quality terms of reference. A mandatory regional market analysis has also been added to the procurement cycle.
“We didn’t do this before, we analyzed the figures only for Moldova. Now, we are looking at purchases and their results in the entire region. This is another level we managed to reach thanks to the Lift program: we started looking at the big picture,” says Vesioli, the CAPCS expert.
After the procurement phase, the delivery of medicines to clinics and patients can be closely monitored using open data tools built by the reform team. Moldova recently launched Scorecard-hiv.md, a public online platform that allows administrators and patients to track the progress of all HIV/AIDS prevention and control programs in real time and detect delays in the procurement process that could lead to drug shortages. It was created in partnership with UNAIDS Moldova, Positive Initiative and other local NGOs and the HIV National Program.
Within the Lift program, Positive Initiative developed the concept for E-Stock, a healthcare stock management system. It aims to help the health ministry plan purchases, control volumes, assess stock levels, and expiration dates. Patients will also be able to use the tool to monitor the availability of their treatments. After crafting the terms of reference with a team of experts from the health ministry with support from UNDP Moldova, Positive Initiative is now raising funds for the IT development.
United for Transparency
Despite all this progress, the reformers faced stubborn points of inertia, which required substantial pressure to overcome. For a long time there was one glaring weakness in medical procurement in Moldova. Although the country has one of the most advanced electronic procurement systems in the world, MTender, all medical procurement was removed from it in 2018. At the time, the system lacked sufficient nuance to support healthcare procurement, but instead of improving it, the government decided CAPCS should continue conducting procurement the old-fashioned way, on paper.
The onset of the COVID-19 pandemic further exacerbated the problem. While OCP was advising governments to conduct emergency procurement as fast and transparently as possible, Moldova took another direction—CAPCS was instructed to collect participants’ proposals as an emailed document. This only made the process more vulnerable to corruption and data manipulation risks.
Positive Initiative was ready for decisive action. They were confident that the united chorus of Moldova’s non-government sector would resonate much louder than the voice of one, albeit savvy, organization. Thus, a coalition of 30 civil society organizations was born, which advocated for all COVID spending to be transparent, preparing a collective list of appeals to the government.
The statement was not merely critical of authorities: in each appeal, there were specific recommendations and proposals for cooperation. By adopting this strategy, the coalition proved to the health ministry that the patient community and the public could be an essential partner in times of need. Instead of a source of conflict, the potential crisis over emergency COVID procurement became a catalyst for even more intense collaboration between government and civil society.
It took only 60 days to join forces and create the Tender.health platform, which continues to be updated with detailed information on COVID procurement—including the roll-out of vaccines—and medicine purchases since 2018. The platform enables near-instant analysis of contracts and spending by entity, supplier and category, while details such as contract specifications, unit prices, quantity and value allow for price comparisons. The tool has become a highly effective tool not just for civic monitoring but also for government entities, who can quickly check the best prices and find the best suppliers. As of October 2021, the site features 5,140 COVID-19 related contracts signed between 324 government buyers and 479 suppliers, and invoices with a total value of around MDL 820 million (US$47.5 million), and 2165 records detailing medicine purchases worth over $40 million, supplied by 24 companies. The government promotes the platform on official websites and has used the civil society coalition’s analysis of the deals to inform its decision-making.
Returning to MTender
As for MTender, civil society’s consistent calls for greater transparency paid off, and once again all medical purchases must be carried out via the open e-procurement system.
“This is a very significant moment. The annual budget for medical purchases in Moldova is about $50 million. Transparency is one of the key tools for reducing the risks of inefficient spending and corruption. The MTender system allows everyone to see everything. It is therefore critical to have all medical procurement take place in this system,” says Charanovsky.
Recently, a business intelligence module was added to the system, with support from OCP. It now takes just moments to analyze procurement in the health sector. Between January 2021, when CAPCS purchases returned to MTender, and the end of October, the central procurement agency successfully completed over 2,533 procurement lots for around $60 million via the system, with average savings of 15.42% compared to the planned value and an average number of 2.27 bids. While these initial results are encouraging, many problems remain unresolved in this sector—including a high level of monopoly and frequent appeals against both the terms of tenders and the awards.
Reflecting on the old days when Positive Initiative had a more antagonistic relationship with authorities, Constantin Charanovsky says:
Over the past three years, by nurturing relationships with progressive civil servants and community groups, patients from some of the most vulnerable groups of society have had a remarkable and unexpected impact on the affordability and availability of medicines. In a market that has been stubbornly opaque and uncompetitive, they’ve proved that civil society can bring a fresh approach to old problems, working alongside the government to modernize the public procurement system, cushioning the impact of an unprecedented health crisis and empowering patients to ensure their right to life-saving medical supplies.