In-depth | Health | Corruption

Pharmaceutical industry in chronic condition

By - 05.06.2018

Corruption, scandals and medicines not fit for purpose.

Medicines, by their very nature, are supposed to heal people. But in Kosovo, the chronic condition of the pharmaceutical industry is often having the opposite effect, leaving citizens — and the state — both poorer and in poor health.

Issues range from problems with medication registration and doubts over quality, to suspicions about corrupt relations between doctors and pharmaceutical companies, inflated prices, and an Essential Medicines List that has been compiled based on the interests of pharmaceutical operators, not the needs of patients. All these issues make this industry one of the most problematic and corrupt in Kosovo.

Just about every link in the chain that is meant to monitor the pharmaceutical industry has failed; high level officials are facing justice, with some already sentenced through to final court verdicts, while successive governments have failed to create a safe pharmaceutical market in which the public system isn’t influenced by private pharmaceutical operators.

The ultimate result for citizens is that they are being forced to pay out for medicines whose costs should be covered by the state. In addition, in some cases medical professionals have raised suspicion about the quality of medication that is being used to treat Kosovo’s citizens.

Extortionate public procurement

In recent years, many of these flaws and abuses, that could perhaps have initially been put down to teething problems in a nascent industry, have begun to be laid bare.  

A prime example is the Ministry of Health’s Essential Medicines List, containing the medicines and supplies with which the Ministry is obliged to supply Kosovo’s hospitals. Until now, the Ministry has introduced no regulation of the market for these essential products, leaving economic operators to set any price they like.

Since 2016, the prices of many individual medications bought by the Ministry have dramatically increased without justification. This multi-million euro cost to the public purse was revealed by Koha Ditore in September last year, before being taken on by NGOs.

Last month, the Columbus Institute, which mainly deals with health care procurement, published a report titled ‘The Pharmaceutical Misuse Warehouse.’ It provides details of about 200 medical products or supplies that were purchased by the Ministry of Health for extortionate prices, showing that in 2016, the same companies that had already been supplying the Ministry raised almost all of their prices from between 100 and 2,000 percent.

The scale of the budgets in question are far from insignificant. In 2017, the Ministry had 21 million euros at its disposal for medications and supplies, with a big part of this budget — up to 40 percent — allocated for cytostatics (medication used to treat cancer).

Minister of Health Uran Ismaili says he recognizes that there are problems with the pharmaceutical sector and says he will ensure abuses of the public budget are not repeated. Photo courtesy of the Ministry of Health.

For it’s part, the Ministry has said it is in the process of producing an Administrative Order that will define conditions for purchasing medicines and regulating the costs of essential medicines that are required for supplying public hospitals. According to Minister of Health Uran Ismaili, up until now Kosovo and Belarus have been the only countries that have lacked a legal basis that defines the cost of medications.

“I cannot cure history, but I can make sure that this abuse of the budget is not repeated,” Ismaili told K2.0. “And for this we need a good legal basis.”

However, after nearly nine months, Minister Ismaili has yet to take any kind of concrete initiative to regulate the private pharmaceutical market — which in turn would help to increase product security.

From the first few days of his mandate, Ismaili has been faced with the scandal of public health institutions purchasing Essential Medicines List medications at much higher prices than those available on the private market.

Visar Ramaj, a lawyer who has worked with many cases of medication and medical supplies procurement, says that in Kosovo there has been a lack of control over the pharmaceutical industry or transparency that would facilitate an increase in competition. “Kosovo does not yet have effective control over prices,” he says. “By having this it would prevent purchases at inflated costs.”

"In some cases the University Clinical Center of Kosovo and the Ministry of Health have allocated funds for specific medications that have prices that are higher than the market value.”

Visar Ramaj, lawyer

Ramaj says that Kosovo does not have an open system of forecasted mid-term (three to five year) purchases, something that would help new companies to enter the market, meaning that established companies are able to dominate. “Kosovo does not yet have a strategy for supporting local producers, but also companies that can buy registration documents,” Ramaj states.

The lawyer highlights that in the past few years there have been a range of issues related to medication procurement in the public sector. He relates some of the issues regarding the purchase of medicines to the way in which procurement has functioned within the Ministry of Health.

“The second most serious issue has been allocating the budget for purchasing pharmaceutical products. In the absence of legal criteria for controlling prices and allocating funds, in some cases the University Clinical Center of Kosovo [QKUK] and the Ministry of Health have allocated funds for specific medications that have prices that are higher than the market value,” says Ramaj, highlighting that this has contributed to a lack of competition regarding tenders, as well as contributing to a situation in which certain companies apply with overinflated prices.

Isuf Zejna, a researcher at Democracy Plus, says that the costs of medicines purchased for the public sector have risen dramatically but that this isn’t reflective of an increase in quality. Photo: Atdhe Mulla / K2.0.

Procurement expert Isuf Zejna is a researcher at the NGO Democracy Plus (D+), which has spent the past two years monitoring the Procurement Review Body, the institution responsible for handling complaints in the public procurement process. Zejna says that issues related to the procurement of medicines in the public system have only become worse in recent years.

“In many cases, the procurement of medicines is conducted through incorrect public procurement procedures and as a result we do not get products of the highest quality and at the best price,” he states. “The cost of medicines that are bought through procurement has increased a lot, but the quality of medications, in certain cases, has stagnated or worsened.”

According to Zejna, the issue is that Kosovo does not update its Essential Medicines List, with the last update taking place in 2013.

“We have an Essential Medicines List that does not meet the needs of the health care institutions, but is in accordance with the needs of a limited number of pharmaceutical companies,” Zejna states.

According to Minister Ismaili, the Essential Medicines List will be revised this year.

“We have only just started work on revising the Essential Medicines List. Commissions have been created, and the whole thing will be concluded within a reasonable time frame,” Ismaili told K2.0. “The revision will be overseen by experts from the World Health Organization and will certainly influence an improvement of the situation.”

(Un)secure medicines

According to the Columbus Institute, the millions of euros that the Ministry of Health has lost purchasing medicines at inflated prices can largely be traced to an Administrative Order published by the Ministry of Health in 2016. The Order introduced increased quality testing criteria for medicines purchased by the state as part of the Essential Medicines List, but simultaneously left some companies with a virtual monopoly of the market.

Previously, medicines that had been registered in Europe, America, Australia or Canada were eligible to be purchased by the state, meaning that international companies could easily compete for Kosovo tenders, thereby ensuring companies had to be competitive in terms of price. But the new Order required medicines to additionally be registered in Kosovo, creating extra costs and detracting international companies who did not want to take extra risks to compete in an unstable market. Without outside competition, and with no market regulation, the limited number of Kosovo-based companies could set virtually whatever prices they chose.

While the extra registration criteria should in theory imply higher quality standards as products should have to undergo additional quality tests, the institution responsible for ensuring quality, the Kosovo Agency for Medical Products and Equipment (AKPPM), has been shrouded in scandals ever since its establishment after the war.

The Kosovo Agency for Medical Products and Equipment is supposed to guarantee the quality of medicines in Kosovo but it has lurched from one scandal to another in recent years. Photo: Atdhe Mulla / K2.0.

Former head of AKPPM Ilir Dushi is one of a number of officials facing prosecution for abusing their official positions or authority, as are other Ministry of Health officials for allegations relating to the pharmaceutical sector.

In 2016, the current head of AKPPM, Jeton Shala, was accused by the State Prosecution in relation to the scandal of stealing confiscated medicines that were being kept at AKPPM. At the time, besides medicines, laptops containing important information about marketing authorization of medicines were also stolen.

Although the Prosecutor worked on the case for two years before filing an indictment, he voluntarily withdrew the indictment in the first court session. The media attempted to request access to the document containing the justification for the Prosecutor’s retraction, but the State Prosecutor rejected the request.

Last year, AKPPM was again caught up in a cycle of scandals in which it was suspected of being involved in an operation that enabled 1 million quality standard stickers to enter the black market.

This was identified in an audit report stamped with the status ‘Not for publication.’ Some of the information contained in this report was later obtained by media.

“We have identified a discrepancy between printed quality standard stickers (21,340,784) and sold quality standard stickers (20,503,919). So we have a difference of 836,865 printed units,” reads the partially leaked report’s findings, which refer to the period between January and September 2017.

“Based on this fact, AKPPM has failed to achieve total control over the adequate management of quality standard stickers,” the report continued. “This failure has two aspects: one is that AKPPM has a shortage of income for this difference, and the other is that these quality standard stickers could end up in the informal market.”

In addition to this, another instance of AKPPM misuse of office was reported by media earlier this year, dominating headlines. Around 300,000 euros were used from different budget codes for international travel, while the institution’s management could only demonstrate adequate documentation for 32,000 euros worth of travels abroad. After the case went public, three officials were suspended and one was arrested, while further investigations are underway.

For weeks, K2.0 has tried to speak with the head of AKPPM, Jeton Shala, but he has not responded to our requests.

Lately, Shala hasn’t been making any statements for the media, however in April he was obliged to appear before the parliamentary Committee on Health, Labour and Social Welfare. Participating deputies, many of whom are doctors by profession, publicly expressed their concerns that the quality of medicines used in Kosovo is not guaranteed.

“AKPPM has not proven itself to be an institution that has the capacity to measure the quality of medical products.”

Besim Kodra, Patients’ Rights Association

The whole institution, which claims to measure medicinal quality, only has 39 employees, and its laboratory is almost completely dysfunctional — medicines are rarely analyzed in it.

At the Committee on Health, Labour and Social Welfare, Kosovo Assembly deputy Naser Rugova claimed that there are many cases in which medicines are missing active substances. “One of the cases is a patient whose situation worsened during a visit to Sweden. During his treatment there, the drugs used in Kosovo were analyzed, with the justification that these should have prevented the deterioration of the situation,” Rugova said, adding that after the analysis, the Swedish doctors concluded that the drugs from Kosovo lacked an active substance.

Active substances are the most important element of medicines, as they define their effect and activity. In addition to active substances, medicines also contain auxiliary substances that facilitate absorption by the body.

One type of medication that has been particularly controversial and caused a public debate last year was biosimilar insulins, which the Ministry of Health started to supply to Kosovar patients suffering from diabetes in 2016. The use of this type of insulin was contested by two endocrinologists, Bardhyl Gashi and Luan Gola, who in November 2016 warned that the effects could be highly dangerous to patients.

This complaint was presented before the Committee on Health, Labour and Social Welfare, where Gashi strongly condemned use of the new insulin, saying: “Citizens shouldn’t have been used as animals in experimentation.”

A couple of years ago it was reported that Kosovo was the only country in Europe that uses a biosimilar insulin called Gensulin. Citizens have publically spoken about how their health condition deteriorated after they started treatment with this product, with many patients complaining to the media that the insulin is inefficient. Their statements were supported by their doctors.

In 2016 patients and doctors complained about the quality of a biosimilar insulin called Gensulin, with Kosovo reportedly the only country in Europe to use it. Photo: Creative Commons.

Besim Kodra, head of the Patients’ Rights Association (PRAK) considers AKPPM to be unable to fulfil its duty of measuring medicinal quality.

“Up to now, AKPPM has not proven itself to be an institution that has the capacity to measure the quality of medical products,” says Kodra, according to whom complaints have been raised many times about the insufficient quality of medicines. He says that the agency has been unable to respond to these concerns. “Therefore, we consider that we must invest in the quality of its services.”

For Isuf Zejna of D+, not only is AKPPM not fulfilling its duty as a quality guarantor, but it is seen more as “a guarantor of monopolies of certain companies.”

“The general impression is that this institution does not control medicinal quality, but rather plays the role of ensuring certain positions and enabling the monopolies of companies in the market,” Zejna says. “You get the impression that its existence is more of a burden for the budget of Kosovo than an asset.”

Doctors flirting with pharmaceutical companies

In addition to suspicions over medicinal cost and quality, there are also huge suspicions about the relations between doctors and pharmaceutical companies.

After the end of the war, pharmaceutical companies conducted a campaign aimed at doctors that work in public hospitals, finding various ways of luring them in with the condition that they prescribe particular medicines. Subsequent investigations have shown that this has also particularly been an issue amongst family doctors in the primary health care service.

In return for incentives from pharmaceutical companies, these doctors are suspected of having directed patients to specific brands of medicines by writing on their prescriptions the market name of medicines, the name of the producing company, and in some cases, even the color of the packaging.

“The link between doctors and companies has been proven and documented many times.”

Isuf Zejna, Democracy Plus

A criminal investigation that includes numerous companies is underway. However, the State Prosecutor has only confirmed the initiation of investigations, and has not made any details public.

Prescribing medicines through their market names is prohibited by the Law on Health, which also prohibits doctors from materially profiting from pharmaceutical companies.

“The legal criterion is very clear: doctors are obliged to prescribe pharmaceutical products based only on generic non-copyrighted names,” lawyer Visar Ramaj says. “Any description based on manufacturers represents a legal violation. The Ministry, Municipal Health Care Directorates and QKUK are obliged to ensure the implementation of this practice.”

However, Besim Kodra from PRAK believes that the law has not been implemented in many cases.

“We think that there is a link between certain health care staff and pharmaceutical companies. The fact that they have prescribed medications with specific names implies this link,” he says. “Moreover, the high rate of prescription of medicines, which is not the case in other countries, only serves to raise suspicions further.”

For Zejna of D+, incontestable facts have often been found among these suspicions.

“The link between doctors and companies has been proven and documented many times. Unfortunately, no one monitors and inspects these links, which could have doubled the influence on the welfare of citizens,” explains Zejna, according to whom this link between doctors and companies or distributors could influence an increase in medicine prices as well as the sale of lower quality medicines.

The abuse regarding medication prescription was also shown in the high profile ‘Stent’ indictment, in which more than 60 doctors, medical professionals and politicians are standing trial for referring patients from public to private hospitals for cardiology procedures in exchange for money. Although the State Prosecutor has considered wiretapped conversations between doctors and pharmaceutical companies to be unimportant in relation to the ‘Stent’ case, these conversations demonstrate that deals between companies and doctors over medicinal prescriptions have taken place.

“Frankly, I haven’t dealt with this issue in the first few months due to more urgent problems that have required urgent solutions to be found by me as minister.”

Uran Ismaili, minister of health

Evidence unearthed during the ‘Stent’ affair investigation suggests that two text messages were sent to many doctors in a span of two months. The content of the text messages shows that the sender, a person named Sellma, is part of a pharmaceutical company, but it is unclear who that person is. It is suspected that the text messages, which were sent to many phone numbers, were sent with the objective of encouraging doctors to increase the rate of prescription for certain medicines.

The first text message — obtained by Kosovo Police’s Economic Crimes Department, one of the investigating bodies in the Stent case — was sent to a large number of doctors on June 6, 2012. It reads: “Greetings. Please start prescribing Bivol, Carvedilen, Plavidosa, because sales are very bad. Respectfully, Sellma.”

A month later, on July 16, 2012, the same number sent another text message to doctors, through which it called for the prescribing of its own medicines, and reminded doctors to work “according to the agreement.” The message states that the sender is unhappy with the low number of prescriptions for two types of medications.

“Greetings. I want to inform you that we have remarks about Carvedilol and Plavidosa. Please prescribe our company’s varieties so that we can also be correct in our cooperation,” read the message, which went on to say that the prescription of these medications was in the interest of all parties.

Minister Ismaili has admitted that he has not dealt a lot with this issue up until now.

“Frankly, I haven’t dealt with this issue in the first few months due to more urgent problems that have required urgent solutions to be found by me as minister,” he told K2.0. “Certainly this issue is problematic and requires a quick solution.”

The Ministry of Health certainly has a lot on its plate. But unless fundamental issues in the pharmaceutical sector are addressed rapidly and comprehensively, the prognosis for developing a functional health system that works for patients could well be terminal.K

Feature image: Atdhe Mulla / K2.0.

Edited by Leurina Mehmeti and Jack Butcher.

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