ࡱ> q`4jbjbjqPqP 4::b%8d^$?" ? ? ? ? ? ? ?$NAhCz1?k*k*k*1?F?222k* ?2k* ?22:7,8 0 Q@?07 ?\?0?7R0D'10D80D8 2*$&m1?1?'2X?k*k*k*k* $  Heading: Journalistic investigation Sub-heading: Pharmaceutical market Lead: People of Georgia do not know what drugs they take. Obvious signs of secret deals and corruption in Georgian pharmaceutical business. Author: Eliso Djanashia and Studio Monitor. This film was made possible by financial support of Danish organization SCOOP. Title: Dark Side of Georgian Pharmacy (or Georgian Pharmacocartel) Oligopolistic pharmaceutical market 48% of total health expenses of a citizen of Georgia go on medicaments, not on doctors care. With under-developed insurance system, patients in Georgia spend money on medicaments from out of their pockets. Medicament expenses are not covered by state initiated Health Insurance for 5 Lari program either. In 2008 Georgias annual inflation rate was at 5.5 %. In light of global and post war crisis prices on products and household goods in Georgia went neither down, nor up. Medicaments were the only exception. In separate cases prices for most commonly used medicaments rose by 200% over the last year. Nika Ramishvili, director of Insurance company Archimedes, has been watching dynamics of increase of medicament prices over the past year. He says that prices for most commonly used medicaments have increased sufficiently. For example, over the period of January-December 2008, prices for ultrabiotics rose from 11.75 to 19 GEL. Preductals price went up from 15.30 to 32-45 GEL. Amoxicilins price rose from 1.48 to 3.20 GEL, Gynipral currently sells at 9 GEL, up from 2.50 and price of Movalis rose from 16.38 to 22 GEL. Considering overall price of up to 7000 medicaments on sale on Georgian market, rise in cost is only 2-3 %, however in case of 100 most commonly used medicaments, rise is sufficient, Ramishvili says. According to Ramishvili prices of most commonly used medicaments have risen by another 10-15 % from November on. We have high rate of unemployment in Georgia. With Banks, insurance agencies and construction companies reducing staff, consumer wealth is further declining. In such circumstances, rising prices on medicaments seems inconsequent, Nika Ramishvili says. But this is how he explains inconsequent phenomena: If I were a president of a pharmaceutical company and if I had not rivals, I would have sold medicaments at a price I want. A market with 2-3 big companies controlling 70-80% of it is oligopolistic. These companies are able to make secret deals to reduce production and increase prices on medicaments artificially. This is what may inflict losses on consumer, an independent expert Davit Narmania says. Official web pages of pharmaceutical companies Aversi and PSP say that Aversi controls 35% of Georgias pharmaceutical market and PSP has 30% of it. The third largest Georgian pharmaceutical company GPC is in control of over 15% of the market. This means that the Georgian pharmaceutical market is oligopolistic. In oligopoly decisions of each company effects overall situation on the market. The companies depend on decisions of fellow oligopolists. Before making a decision, each oligopolist has to consider interests of other players on the market. Some time ago Georgian president indicated that theres no adequate competition on pharmaceutical market. He demanded that the cabinet facilitates increase in competition, thus the president admitted indirectly that the pharmaceutical market of Georgia is monopolized. Absence of state control and uncontrolled prices In the EU countries, with exception of Great Britain and Germany, governments directly control prices on medicaments. In Great Britain and Germany only prices of newly patented medicaments are free. In Georgia, unlike Georgian pharmaceutical market, prices on medicaments are free, so free and uncontrolled that sometimes sales prices on medicaments are up 1000% compared to their cost (fasnamati). According to pharmaceutical company PSP, rise of prices by foreign producers and exchange rate variability are two factors causing rise in medicament prices in Georgia. We are powerless against rise of prices caused by variability of exchange rate, PSP says. Exchange rate variability of euro and dollar effects medicament prices, but the problem is that when foreign exchange rates go up, pharmaceutical companies increase their prices at once, but when exchange rates go down, unfortunately, nobody cuts prices on medicaments, expert Davit Narmania says. According to information that we gained, difference between import prices of medicaments and their sales prices makes hundreds of percent. This information we retrieved from specific invoices. See registration number and dates of those invoices: Sales price of Duovit is 11.22 GEL. Import price is 1.5 EUR. Margin (difference in price) is 247.4% (Invoice #329 2008, September 22, PSP) Sales price of Ciprinol is 9.87 GEL. Import price is 1.75 EUR. Margin (difference in price) is 162% (Invoice #329 2008, September 22, PSP) Sales price of Valocordin (50ml) is 9.36 GEL. Import price is 0.73 EUR. Margin (difference in price) is 208% (Invoice #276 2008, July 26, PSP) Sales price of PEO 1 (ceftriaxone) is 13.48 GEL. Import price is 0.75 EUR. Margin (difference in price) is 735% (Invoice #225 2008, June 26, PSP) PSP did not confirm above mentioned margins (differences) between import and sales prices of medicaments. According to PSP, their margins are about 0.30% in wholesale trade and 0.20% in retails. However, a representative of PSPs pharmaceutical factory GMP, Giorgi Antadze, gave a different answer to the same question in television program Business Courier (18.06.2009). He did not deny that the margins were high, but he said that it was because of transportation, operation and other expenses of the company. On August 15, 2005 Euro Health Group, a Danish-based health consultancy firm, published recommendations on pharmaceutical policies and regulations in Georgia. One of the 16 points of the recommendations read that Georgias Agency for Health Care Policies should use different methods to regulate prices of medicaments to somehow establish their initial prices. In similar recommendations that different international organizations prepare from time to time, Georgian authorities spend millions of dollars, but none of those recommendations have ever been fulfilled. Reason for disappearance of new pharmacies from Georgian market According to Ministry of Healthcare, Georgia imports more then 6000 medicaments. In 2006 total import value was 99 million dollars. In 2007 medicaments total import costs reached 145 million dollars and in 2008 they reached 129 millions. Almost half of medicaments were imported by PSP and Aversi. Their share in medicament import is almost the same as that of other 50 importers together. Three main players (PSP, Aversi, GPC) on Georgian pharmaceutical market have an agreement between each other that they cooperate with different suppliers. If one of them works with Richter, other two do not meddle. If you tell Richter that you are a new organization and you want to cooperate with them, they tell you: I already have a partner in Georgia and I do not need another, An owner of one of the small pharmacies says. Fearing problems he did not disclose his name. Pharmacies like his have no chance to cooperate with big medicament producers. They are forced to buy medicaments from local importers almost at a retail price. Valeri Kvaratskhelia is owner of a company Peoples Pharmacy and its 33 drug-stores. He recalls times when he was entering Georgian pharmaceutical market. Dealing with foreign medicament producers proved difficult. It took us 2 years to make a breakthrough. The first foreign company who signed a contract with us was Berlinham (internetSi am kompanias ver mivakvlie, saxeli xo mar aris shetsdomit?). After we made a deal with them, our competitors tried to damp prices. At the beginning Russian Protek was providing medicaments to us. This increased our prices, because between us and a producer we had a third company. When you make an order and your competitor damps price, this may not affect big companies, but this can almost certainly destroy a small venture. Many small companies disappeared because of damping. We also lost money but we survived. PSP has 120 pharmacies in Georgia. Aversi owns 160 of them. At the same time PSP and Aversi are the biggest importers of medicaments in Georgia. Other pharmacies buy most of drugs from these two companies. Aversi and PSP sell drugs to small pharmacies at a price which is 14% less then retail prices introduced by Aversi and PSP themselves. It means that apart from conducting wholesale and retail trading, Aversi and PSP fully control profits of other pharmacies. Newly established pharmacies cannot sell drugs at a price higher than that set by Aversi and PSP, or else they risk losing competition. From 14% discount new pharmacies can hardly make any profit. They spend most of their income on taxes and find it difficult to stay in business. One of our respondents says that with a 14% discount small pharmacies cannot keep their stores. According to statistics, number of pharmacies of Aversi and PSP is increasing, while number of independent pharmacies is going down. Answering to a question as to why they set only a 14% discount, PSP gives a very general comment: It is a rule of business that both in retail and wholesale trade, discount is based on amount of purchases and conditions of payment. In European countries medicament prices are regulated by law. In most of the countries difference between wholesale and retail prices of medicaments is between 20 and 30%. The only exception is Great Britain with 17%, but in Britain pharmacies do not pay VAT (Regulation of Pharmaceutical Sector in Europe: for Efficiency, Quality and Equality, written by E. Mosialos, M. Mrazek, T. Wall). Difference of 14% between wholesale and retail prices of medicaments is only in Georgia. Aversi and PSP, owners of clinics Aversi and PSP are the biggest importers of medicaments to Georgia. They own pharmaceutical factories and produce their own generics for medicaments. They also own private clinics. Aversi owns a number of clinics including those in Tbilisi, Marneuli Rustavi, Lanchkhuti and Gori. PSP has a similar ambition. This is what PSPs web page says: PSP group is potentially the biggest hospital operator in Georgia. PSP can take over 35-40% of Georgias medical market. How fair and ethical is it to produce, distribute, prescribe and treat simultaneously with own medicaments? Dont we have a conflict of interests when pharmaceutical companies are opening their own clinics? This is what PSP says in this regards: There is no conflict of interests. We believe that the company with a significant knowledge of health care issues can run hospitals at the highest possible standards. This is a common practice in the U.S. and Germany. To get a further control over Georgian pharmaceutical market, Aversi and PSP advice Georgian doctors to prescribe medicaments from their own pharmacies. Doctors do not speak of this practice on the record, but patients showed us papers carrying Aversi and PSP logos. These are papers where doctors write prescribed medicaments. Prescription is made in two copies. One copy of a paper is for a patient. A patient takes it to the specific drug-store, buys a medicament and leaves the paper there. The second copy remains with a doctor to prove that he/she prescribed indeed a medicament of the specific company. This is how pharmaceutical companies control doctors. Documents for internal use only show us that in return for prescribing a certain amount of medicaments, pharmaceutical companies send doctors to international conferences, or pay them bonuses in cash. Human Rights Center (HRC) unmasks illegal deals between doctors and pharmaceutical companies. According to HRC, doctors tell their patients which pharmacies they need to buy prescribed medicaments. Pretty often a patient does not need treatment with prescribed medicaments at all, but doctors still make them buy expensive medicaments. We found out that doctors receive 7% of the total price of sold medicaments, HRC says. One doctor has confirmed that this is the case indeed. Illegal production Georgian legislation says that before registering generics, research materials proving that generics are bioequivalent to original medicaments should also be tested (Generic is a preparation patent of which has expired, therefore it is no longer property of its inventor and can be produced by other manufacturers. Bioequivalence means compliance of generics to original medicaments). However, legislation does not say who should test bioequivalence of medicaments produced by Georgian pharmaceutical companies. Pharmaceutical companies do testing themselves, which means that the state trusts them blindly. According to Medical Regulation Agency, 24 medicaments produced in Georgia have been tested. Medical experts question this number. The experts say that in a couple of months testing dozens of generics is impossible. PSP says they have tested 21 of their own medicaments. They also say that they have spent 4-6 months testing each of them. Even if the information provided by the PSP is correct, it is not a significant achievement because Georgia is a producer of 907 medicaments. Bioequivalence of Georgian generics have not been tested, says medical expert Tina Turdzeladze. This means that nobody knows whether medicaments produced in Georgia comply with original medicaments or whether they are of high quality. meanwhile number of generics in Georgian pharmacies is increasing every day. Generics are replacing original medicaments. Introduction of some generics have ended up in court. Its almost a year that the French pharmaceutical company, Laboratoire Servier is suing GMP, PSPs pharmaceutical factory. GMP has been producing medicaments, Agulan and Amra for 2 years. The French company claims that both medicaments have a substance called perindopril in it, which has been patented by Laboratoire Servier. Lawyers of the French company say that the French and British laboratories have confirmed that the Georgian medicaments consist of perindopril. However Georgian court has not considered this argument. GMP has filed its own suit against Laboratoire Servier and blamed it for illegally obtaining patent in Georgia. According to the latest information GMP has lost the case. GMP produces generic of those medicaments whose patent has expired. In case of Laboratoire Servier, we question legality of its patent in Georgia. Their patent has expired in Europe, therefore it must be abolished in Georgia, According to PSP. Georgian pharmaceutical companies try to replace patented foreign original medicaments by their own products. Georgian market is too small for pharmaceutical giants and therefore of little interest. They rarely try to defend their interests on Georgian market, Turdzeladze says. Unlike Laboratoire Servier, Swiss giant Hoffman-La Roshe does not mind that its medicament Xenical has been replaced by Georgian generic Orlip, which is also produced by GMP. Giorgi Ramishvili, the representative of the Hoffman-La Roshe in Georgia, says what GMP does is not illegal. Xenical has international patent, but it has no Georgian patent. However Orlip cannot be sold in Europe, because in Europe Hoffman-La Roshe sells its own product. Lobbyists of pharmaceutical companies in government Respectful audience! I want to introduce you with my vision of the problem, as of a member of parliament and a manager of pharmaceutical sector, (excerpt from a transcript #51 of Parliaments Health and Social issues Committee meeting, 28.08.2005) This is how MP Okriashvili began his speech at the committee meeting. He talked little of the quality of medicaments and openly called on Medicament Agency towards protecting pharmaceutical business: Pharmacy is part of economy. Supporting its development must be part of a every day job of every employee of the Medicament Agency. There are two contradictions in Okriashvilis speech. First: Georgian legislation forbids parliament member holding a managing position in any commercial company. And second: Medicament Agency was formed to ensure that the state oversees and controls pharmaceutical companies that they provide effective, safe and quality medicaments to people. Lobbying pharmaceutical business is not Medicament Agencys function. On July 1, 2005 Kakha Okriashvili explained to parliament that the aim of a draft law initiated by him was to ensure support for government plan to invigorate businesses by simplifying bureaucratic procedures. In the transcript of the committee meeting we read Gigi Tseretelis comment that amendments to law have been initiated by Kakha Okriashvili. There were two major amendments to the law. The amendments simplified obtaining rights of import and selling of medicaments for those seeking registration of the products. According to amendments: If registration request is denied by the Medicament Agency, the Agency is obliged to send a person seeking registration a well-founded denial in a written form. If within the timeframe defined by the law a person seeking registration is not notified about denial of his request, medicament is regarded as registered and the agency is obliged to issue a certificate of registration. By the same amendments, timeframe for registration of medicaments was reduced from 4 to 3 months. Tina Turdzeladze, a former chief of Medicament Agency, says that the main instrument for regulation of the pharmaceutical market is registration. During registration procedure state agency tests medicaments and allows them onto the market. But the state limited a registration period and reduced staff of Medicament Agency by cutting its funding. The amendments have also increased risk that rejected medicament may still enter market if timeframe of notification is not met. The entry made by the health committee into law on medicaments is unprecedented in the history of worlds pharmaceutical legislation, According to Turdzeladze. Another significant amendment to the legislation regulating a pharmaceutical market was made on May 3, 2002. That amendment was dealing with serial control of medicaments. Amiran Gamkrelidze, Georgias Health Minister back in 2002, signed a decree to subject following items to mandatory serial control: a) substances; b) Narcotics and painkillers; c) vaccines and serums; d) blood preparations, blood replacements and solutions for conservation; e) antibiotics; f) infusion solutions; g) medicaments for injection; h) eye drops; i) pediatric medicaments. After a month the Health Minister signed another decree and removed e) antibiotics; f) infusion solutions; g) medicaments for injection; h) eye drops; i) pediatric medicaments from the above list. Since then medicaments of these specific groups are no longer subject to mandatory serial control. After analyzing ministers second decision, we come to a conclusion that he stopped serial control of all those medicaments that were imported in Georgia by private businesses. Only those medicaments which are imported by state (e.g.: Narcotics and serums) remain on the list. According to this decree substances (of which medicaments are made) remain under serial control. But medical experts say that neither substances are subject of proper control. No one knows what are medicaments made of. Pharmaceutical companies make substances, test ready-made medicaments and issue certificates themselves. We need to have random testing on a regular basis, not only once or twice a year, Ketevan Baramidze, the director of Geolab laboratory, says. PSP says that substances are imported from the U.S. and leading European states. Series of active substances used in medicament production is tested in GMPs modern laboratory. Aversi representatives rejected our interview request. They did not answer our questions that we submitted in written form either. Medicaments themselves, whose substances are imported from different countries, do not carry on their boxes names of the producer countries. Medicament boxes read that they are made in Georgia. This means that customers do not know which country has made substance that was later used for making medicaments. Not giving name of substance producer is the best way to disguise suspicious origin of medicament. Like serial control, Georgian legislation makes selective testing of medicaments obligatory. In 2007 and 2008 Medicament Agency had a contract with Geolab laboratory which was selected in a tender. From October 2007 Geolab tested 236 medicaments. 39 of those medicaments (17%) proved useless. The same year Medicament Agency asked Geolab to test 97 patterns of registration. In 12 cases methods of analysis proved useless, while in 43 cases methods were put in a group of risk. In 2008, Medicament Agency signed a contract with Geolab on October 29, which is almost the end of the year. Medicaments for testing, including 47 patters of registration and 39 medicaments, were submitted to Geolab laboratory only in December. From 47 patterns, 3 proved useless. In 7 cases methods of analysis were useless, which means that usefulness of those medicaments could not be confirmed. From 39 medicaments submitted for testing, all of them proved to be of high quality. As for 2009, over this period pharmaceutical market is left without control. When a country does not buy medicaments and tests only 39 of them towards the end of the year, this is not testing, Ketevan Baramidze says. In 2009 Medicament Agency signed a contract with a state run laboratory called Medicament Quality Control Center. This laboratory has no special tester. Therefore it is unable to conduct complete analysis on its own and it will test a number of medicaments in a lab of PSPs GMP Pharmaceutical Factory. According to Ketevan Baramidze, this is a clear conflict of interests. Testing medicaments in a lab of the local producer means that the local producer will easily seize foreign manufacturers confidential methods of analysis and dossiers of medicaments. GMP sees no conflict of interests. GMP says that in every country manufacturer tests quality of its own medicaments itself. And if authorities want to double check quality of product, they should have suitable instruments for that. Georgian pharmaceutical market sells about 18000 preparations of over 6000 medicaments in different dozes and forms. Last year Medicament Agency has tested only 39 of them. It is governments responsibility to control quality of medicaments. But instead government representatives are advertising products of private pharmaceutical companies. Georgias Minister of Economy Lasha Zhvania says: Pay attention to the logo of this (GMP) producer and buy Georgian made medicaments. Thus you will support Georgian producer. You will also support creating jobs and investing more money in Georgian economy. Buy only Georgian made medicaments, which are of high quality, identical to medicaments produced abroad and quite cheap. (excerpt from PSPs official web page). Secret dealings between pharmaceutical companies and authorities By a decree #719 of Georgian cabinet, issued on December 17, 2007, Kutaisi city municipality received 755000 GEL from Georgian governments reserve fund to provide Kutaisi pensioners with medicaments. The same day Mayor of Kutaisi formed a temporary jury to select a pharmacy for the program. The same day, on December 17, newspaper 24 Hours published a statement inviting pharmacies to participate in the program. According to the statement, applications were due to be submitted between 10:00-16:00 on December 18. The same day, December 18, Kutaisi municipality was due to announce the winner after 16:00. Protocol of the jury meeting, made at 16:30, December 18 announces joint application from Aversi and PSP as winner (excerpt from government funds monitoring account by GYLA, Georgias Young Lawyers Association). Couple of months later, PSP and Aversi transferred 100000 GEL each to a ruling National Movement party for their election campaign. PSPs founder ran for parliament mandate from National Movement himself. Today he is a member of Parliaments majority. Todays Reality Theres almost no state control of quality on medicaments. Pharmaceutical companies are importers of medicaments. They are also distributors, manufacturers and customers of their own products because they own a certain number of hospitals. It may sound like a paradox, but instead of increasing competition, authorities gave above mentioned pharmaceutical companies exclusive right to control quality of medicaments. On Georgian pharmaceutical market, lack of state control on quality, affects trust in medicaments and causes catastrophic rise in prices. Today people in Georgia do not know what medicaments they are taking and how effective those medicaments are for their health.     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