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Category: Pharmaceutical sector

  • Big Pharma Greed and Artificial Prices – Knocking on Door to Limit Access to HIV Medicines in Georgia

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    • Respect for human dignity and human rights is the ethical foundation of everything we do.[1]
    • We are inspired by the opportunity to address unmet medical needs for patients living with life-threatening diseases around the world.[2]
    • We aspire to improve the health and wellness of people worldwide and to expand access to our medicines and vaccines.[3]
    • We are passionate about transforming patients’ lives. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations.[4]
    • We do more than treat diseases—we aim to make a remarkable impact on people’s lives.[5]

    These are excerpts from the values of pharmaceutical companies that are global leaders in inventing and producing many essential medicines, including HIV / AIDS antiretroviral drugs.

    With these values, the companies position and introduce themselves to the world.

    They produce medicines that can save lives and at the same time artificially restrict access to these drugs for financially deprived people and for countries that fall outside their commercial interests.

    “We did not develop this medicine for Indians.”

    We developed it for Western patients who can afford it ‘

    Marijn Dekkers – Bayer CEO in 2010 – 2016

    Thanks to the decades-long existence of effective antiretroviral medicines, HIV/AIDS is no longer considered to be a fatal disease. A timely and regular administration of these drugs ensures that a human life is not endangered.

    However, despite the inspiring values on websites, artificial barriers created by these pharmaceutical companies are one of the main reasons that millions of people die every year worldwide, because of HIV / AIDS only because they have no access to medications.

    Why?

    Because a human’s life costs less than a medicine which can save his or her life.

    Pharmaceutical companies are artificially maintaining high prices for essential drugs. The barriers created by them are mainly related to the establishment of monopolies on the market and the restriction of production of generic medicines and their access to the market through protecting patent rights and extending them as much as possible.

    What is happening in Georgia?

    HIV / AIDS treatment in Georgia has been available since 2004 with the financial support of the Global Fund to Fight AIDS, Tuberculosis, and Malaria, whereby treatment is provided free of charge to all people who are diagnosed and registered in the national program.

    The procurement of medications within the programs is carried out by the Global Fund’s Pooled Procurement Mechanism (PPM).

    PPM is a strategy designed to create an economically favorable and efficient mechanism for procuring essential medicines.

    Due to the volumes of procurements proceeded by the Global Fund, PPM creates opportunities for financial savings and a significant decrease of prices of medications.[6]

    The key principle of this mechanism lies on ‘’Framework Agreements’’ with ARV manufacturing pharmaceutical companies that defines pre-negotiated favorable prices within procurement carried out by the Global Fund. While using this mechanism, a country can avoid the patent rights of pharmaceutical companies and the restrictions imposed by them.

    However, due to the recent developments, Georgia faces significant challenges, which can cause significant barriers to the access of HIV treatment.

    As a result of the renewal of the countries’ classification system according to their income level by the World Bank[7] in 2014; as well as the introduction of a new funding model (NFM) [8] by the Global Fund to Fight AIDS, Tuberculosis and Malaria, Georgia belongs to so-called transitioning countries in terms of funding[9]. This entails the gradual reduction in funding by the Global Fund and the need to increase state allocations, including for procurement of HIV / AIDS ARV medicines.

    Under the framework of state funding, the issue related to procurement mechanisms of medications comes to the agenda. In particular, through which mechanism and, most importantly, at what price the medications will be procured.

    Georgian legislation in the field of state procurement, regulation of intellectual property rights and patent rights is not sufficiently flexible to ensure the procurement of quality drugs at favorable prices, to promote market competition and to open access to generic medications as well as to create opportunities for using international mechanisms for reducing drug prices.

    This challenge is accompanied by the commitments under the Association Agreement (AA)[10] signed between Georgia and the European Union in 2014, which obliges the country to carry out the relevant legislative amendments directly aimed at creating favorable conditions for the brand pharmaceutical industry.

    These legislative amendments include additional measures to protect patent rights on pharmaceutical products, in particular, to extend patent terms and to ensure so-called data exclusivity to guarantee the confidentiality of information and to prevent its usage by third parties thus directly limiting access to the local market for the generic manufacturers.

    Most of the legislative amendments relating to the commitments undertaken within the AA were implemented in 2017[11]. These amendments pose a significant threat to the availability of drugs, including HIV antiretroviral medications, especially under state procurements.

    What reality may we face?

    HIV antiretroviral medications have been procured by allocations from the state budget since 2016.

    The procurement of drugs with state budgetary sources is also carried out by using the Global Fund’s mechanism which, temporarily allows a country to avoid potential challenges. However, the main remaining questions are:

    • whether this mechanism will remain available for the use after the country’s transition from the Global Fund
    • and whether the country will be able to use the same benefits, including, to evade patent rights

    Georgia, as a country with a low disease burden of HIV infection and, accordingly, with a low purchase power is not commercially interesting for pharmaceutical companies. Therefore, they will try to set the highest possible prices for medications to maximize their profits.

    Taking into consideration that the incidence of HIV infection in the country is rising over years, this can become a quite heavy burden for the state budget.

    To illustrate, we can compare prices of drugs procured by the Global Fund mechanism in Georgia with prices of the same drugs in other countries purchased under state procurement:

    Georgia (Global Fund Mechanism) Poland

    (State Procurement)

    		 Latvia

    (State Procurement)
    Unit Cost

    $

    		 Package Cost

    $

    		 Unit Cost

    $

    		 Package Cost

    $

    		 Unit Cost

    $

    		 Package Cost

    $
    Abacavir 300mg tablet 0.1832 10.99 3.8125 228.75 3.4702 208.21
    Abacavir + Lamivudine (combined drug) 600/300mg tablet 0.4163 12.49 14.1667 425 11.619 348.57
    Atazanavir 300mg capsule 0.6 18 15.4167 462.5 14.8337 445.01
    Darunavir 600mg tablet 1.667 70 11.025 661.5 11.6655 699.93[12]

     

    This data is a clear illustration of what realities we may face and how big the rise in the level of expenditures we will have to deal with.

    In countries indicated in the table as examples (Poland, Latvia) high prices on medications are exactly due to monopolies of pharmaceutical companies and patent restrictions which limit the availability of generic medicines on the market, restrict competition and decrease in prices of drugs.

    To avoid similar developments in the country, it is important to immediately start working on changes in local legislation to create a favorable environment in terms of the availability of drugs and to establish a legal framework which will allow for making use of internationally recognized mechanisms for reducing prices of medications.

    Health is a fundamental human right, that also covers access to essential lifesaving medicines. The invention of the medication and its physical existence does not mean access to it. We live in an environment where human life is in danger due to the greed of the pharmaceutical industry, where a human life depends on how much money an individual has. The state is obliged to provide a person with the right to health!

     

     

    [1] https://www.bayer.com/en/our-values.aspx

    [2] http://www.gilead.com/about/ethics

    [3] http://www.merck.com/about/home.html

    [4] https://www.roche.com/about/our_purpose.htm

    [5] https://www.abbvie.com/our-company/about-abbvie.html

    [6] https://www.theglobalfund.org/en/sourcing-management/health-products/

    [7] https://datahelpdesk.worldbank.org/knowledgebase/articles/378834-how-does-the-world-bank-classify-countries

    [8] https://www.theglobalfund.org/en/funding-model/

    [9]https://www.theglobalfund.org/media/5641/core_projectedtransitionsby2025_list_en.pdf?u=636649300140000000

    [10] http://www.parliament.ge/uploads/other/34/34754.pdf

    [11] http://www.sakpatenti.gov.ge/media/page_files/patent_law_2017_Iy62qmS.pdf

    [12] http://arv.ecuo.org/[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column width=”1/1″][ultimate_spacer height=”30″][/vc_column][/vc_row]

  • CIF Pharmaceutical Price and Availability Study in Georgia

    Status: Closed project

    Introduction and Overview

    The goal of this project is to generate evidence and information on pharmaceutical prices and their availability at pharmacies; the enforcement of regulations regarding prescriptions; as well as pharmaceutical industry practices, in order to inform and strengthen health policy.

    Organizations involved in the research

    Curatio International Foundation conducts the fifth wave of the survay that is supported by the World Bank.

    Expected results and their application

    The objective of this study is to continue the series of Pharma surveys. The fifth round employs the same international methodology for measuring medicine prices that was used in the previous rounds, and attempts to collect information on medicine prices and the physical availability of a pre-selected list of medicines (brand and lowest price generics, with and without prescription requirements).

    The data allows international comparisons as well, using an external standard for the evaluation of local prices recommended by Management Sciences for Health (MSH) ‘International Drug Price Indicator Guide’. In addition, the survey also helps to determine and present an affordability trend among population.

    Furthermore, customs data on import prices for survey medicines (except of local production) is obtained from the Ministry of Labour, Health and Social Affairs (MoLHSA). This allows for the calculation of retail mark-up percentages for survey medicines for both brands and generics.

     

  • CIF Pharmaceutical Price and Availability Study (Fifth Wave Results)

    The Curatio International Foundation has released the results of the fifth wave of the Pharmaceutical Price and Availability (PPA) study in Georgia. The study set out to generate further evidence regarding pharmaceutical prices and availability in the country through the continuous monitoring of the prices of medicine. One of the chief aims of the study is to inform and strengthen health policy and contribute to evidence-based discussions around current trends and processes in pharmaceutical market in Georgia.

    The study analyzes the current, as well as the previous four waves of the PPA studies that have been conducted by CIF since 2009. The main findings of the research responds to two important questions:

    1. What is the trend of physical and financial availability for Generic (LPG) and Originator rand (OB) drugs in Georgia, and how is the treatment cost linked to the availability?
    2. How is Georgia’s pharmaceutical sector being developed after the introduction of the new prescription policy?

    The answers to these questions are available in the main findings of the study:

    Main Findings

    AVAILABILITY

    • Currently, OB availability is almost two-times higher compared to LPG
    • The observed trend in decreased LPG availability can be attributed to several factors:
      • Insufficient knowledge and/or trust in the quality of LPGs among consumers and providers
      • Low demand for LPGs among the population caused by physician reluctance to prescribe generic medicines
      • The revenue-maximizing strategy of pharmaceutical suppliers
    TRENDS IN PRICING STRATEGIES
    •  It is likely that increased competition caused by legal changes in the country’s drug laws in late 2009 determined the downward trend in the OB prices observed during 2009-2012 waves, albeit OB prices rebounded and significantly increased in 2016
    • OBs are largely imported from western countries. Therefore, it is possible that the price increase documented in 2016 can be partially attributed to the significant devaluation of the country’s national currency against the USD and Euro that began in late 2014, and continued throughout 2015. Consequently, OB prices increased in both pharmacy networks and in independent pharmacies
    • In 2015, MoLHSA initiated a new prescription policy with the aim of reducing the level of irrational drug use in the Country. The importance and/or need for prescription system introduction is unquestionable, like in many other countries; however, the insufficiency and/or lack of the necessary instruments for the effective operation of the system most likely allowed pharmaceutical companies to use this initiative to further increase their profits. This assumption is supported by the fact that while in 2012 markups were largely comparable for prescription and non-prescription drugs, in 2016, we observed significant changes in behavior. Namely, markups for prescription OBs are now 89% higher compared to non-prescription OBs, and markups on prescription LPGs are currently 210% higher compared to non-prescription LPGs
    • Surprisingly, locally-manufactured LPGs are sold at a higher price compared to their imported equivalents, most likely affording greater profit potential to local manufacturers. Along with the marketing strategies used by the largest retail networks (also linked to local manufacturing), the promotion of locally-produced drugs over imported drugs helps local producers effectively use their market power in a poorly-regulated marketplace
    EMERGING POLICY RECOMMENDATIONS

    A single policy intervention in a complex pharmaceutical market like Georgia’s will most likely fail to meet its objective i.e. a reduction in costs to the public, and improved access to pharmaceuticals. Therefore, the government needs to immediately implement a multi-pronged policy to better address the issue.

    This policy should include the following:

    1. The introduction of reference pricing on the market – the government can achieve this by learning from other countries’ (high/low/middle-income) experiences and best practices. Through observing others’ experiences, the most appropriate reference pricing methodology can be utilized to further facilitate the regulation of drug prices in the country.
    2. Encourage the use of generic prescription drugs and enforce the generic substitution in the prescription of medicines.
    3. Introduce strict rules and controls for drug promotion, marketing, education, and sponsorship gifts to doctors.
    4. Enhance pharmaceutical market monitoring to adequately adjust for weaknesses in the policy or its implementation.

    The full report is available here.

     About the Study

    The study was conducted using World Health Organization (WHO) standard methodology. The survey looked at the prices and mark-ups of 52 medicines (brand-name medicines and their generic equivalents) in six regions of Georgia.

    CIF has been conducting the PPA study since 2009. The results of the study’s previous waves were released in 2010, 2011, 2012 and 2014.

     

  • Rapid Assessment of Pharmaceutical Sector and Drug Supply Chain

    Rapid Assessment of Pharmaceutical Sector in Uzbekistan project was funded by The World Bank and implemented by Curatio International Foundation in partnership with Credes (France). The project commenced in 2003.

    The main objective of the project was to perform a rapid assessment designed to gather information on different issues like drug policy and regulation, strategic framework, product selection, forecasting methods, procurement mechanisms, quality assurance, storage, transport, and reporting. Other issues studied were the structures of public and private distribution systems, the types and values of drugs flowing through, and the availability of essential drugs.

    The Rapid Assessment covered the following major tasks:

    Review the relevance of several rapid assessment tools that are available (through WHO, John Snow Inc, Management for Sciences for Health, and Boston University);
    Adapt the tools for Uzbekistan;
    Gather data using several defined methodologies, such as in-depth interviews, focus groups, record review, flow-charting;
    Compile and triangulate the data and seek clarifications where data shows conflicting results;
    Compile a report providing a review of each of the supply chain functions, their strengths and weaknesses;
    For a sample of drugs, collect data on the base price for drugs manufactured or imported into Uzbekistan, other additional costs such as duties, clearing charges, taxes, storage fees, and transport costs, markups, dispensing fees for drugs that pass through the public and commercial and semi-private systems;
    Conduct a literature review of both published and gray materials on pharmaceuticals and Uzbekistan;
    Present findings in a stakeholder workshop.
    In order to obtain the most precise picture of the sector, the following activities were conducted:

    Meetings with the MoH, Pharmacology Committee and CPIB to clarify the objective of the assignment and the organization of the mission;
    Preparation and definition of a methodology for rapid assessment and development of approach for completion of study;
    Meetings and discussions with key partners, stakeholders and policy-makers.
    Assessment design was performed considering the following steps:

    Define the method of interview and rapid appraisal techniques (in-depth interviews, record
    review);
    Identify and select the geographic sites to be visited and the major stakeholders to be met;
    List the major topics to focus on;
    Organize the teamwork and review the activities schedule;
    Sample the drugs for the prices analysis.

  • Fourth Wave Results of Pharmaceutical Study Published

    Curatio International Foundation has completed a study exploring ‘Price, Affordability and Availability of Medicines in Georgia’. The study was divided into three stages and carried out in 2009-2001.

    The key aim of the study is to improve affordability and availability of medicines for the population.

    Based on a three-year observation of pharmacies and different medicines in Georgia, Curatio International Foundation studied the practice in the pharmaceutical sector and came up with recommendations based on research findings. The recommendations will be presented to the broad audience of the health sector – the Health Care Committee of Parliament, the Ministry of Health, the insurance sector and other interested parties.

    The study was conducted using the methodology of the World Health Organization (WHO). The survey looked at prices and mark-ups of 52 medicines (brand-name medicines and their cheap generic equivalents) over the period of three years in licensed pharmacies nationwide.

    Findings and recommendations of three stages were unveiled in December 2011.

    Read more on study methodology, findings and recommendations- Presentation (available in English) and Brief (available in Georgian).

  • Price, availability and affordability of medicines in Georgia-2009-2011

    The present report unveils the findings of the study “Price, availability and affordability of medicines in Georgia” implemented over the course of three years- 2009-2011 in the capital Tbilisi and regional cities. The study was supported by the World Bank and the Open Society Institute.

    The survey looked at availability and price of Innovative Brands and their equivalent low price generics, analyzed collected data by type of medicine, regional differences as well as by type of pharmacy. The survey also looks at medicine mark-ups and compares with mark-ups in European countries, measures affordability of standard treatments as percent of average subsistence monthly allowance and provides comparison of the standard treatments by innovative brands and equivalent low price generics.

    The present report “Price, availability and affordability of medicines in Georgia” attempted to obtain reliable data on these aspects and documents tendencies of change over the course of three years. Over the course of three years the study covered almost all licensed pharmacies and 52 types of medications in the capital Tbilisi and regional cities.

    The power point presentation document and brief study report can be viewed here (yet avaialble only in Georgian).

  • Findings of the pharmaceutical market study in 2009-2011 years

    The key aim of the study is to improve affordability and availability of medicines for the population.

    Based on a three-year observation of pharmacies and different medicines in Georgia, Curatio International Foundation studied the practice in the pharmaceutical sector and came up with recommendations based on research findings. The recommendations will be presented to the broad audience of the health sector – the Health Care Committee of Parliament, the Ministry of Health, the insurance sector and other interested parties.

    Giorgi Gotsadze, the Curatio International Foundation Director: “Through the study we provide strong evidence to decision and policy makers on the current condition of the pharmaceutical market. We hope that this study will foster debates between the interested parties”.

    The study was conducted using the methodology of the World Health Organization (WHO). The survey looked at prices and mark-ups of 52 medicines (brand-name medicines and their cheap generic equivalents) over the period of three years in licensed pharmacies nationwide.

    The survey measures the quality of access to medicines in both pharmacy chains and independent pharmacies. In 2011, Pharmadepo and Parmacenter added to the pharmacy chains involved in the survey (PSP, Aversi, GPC) in 2009-2010.
    The survey looks at the access to medicines by years as well. It analysis the impact of amendments made in 2009 to the Law on Drugs on the access to medicines and medicine prices in Georgia. The survey analysis how the changes influence the patients’ treatment costs in patients with different diagnosis.

    The survey has found that:

    • The market has witnesses a tougher rivalry since 2009, which has likely led to the reduction of markups of brand-name products. Markups decreased most in 2001;
    • The year 2011 witnessed an increase in access to both brand-name products and their cheap generic equivalents;
    • Despite improved affordability the market is experiencing a lack of generic products;
    • Access to medicines varies by regions. Access, especially the access to generic medicines, in some regions is still low;
    • The level of access is highest in the Pharmadepo/Pharmacenter pharmacy chain and lowest in independent pharmacies, which is likely to be the result of unequal competition among pharmacies;
    • Even though there is a decreasing trend in medicine markups, the markups in Georgia are higher than in European states, which means that Georgian importers add more funds to medicine prices than European ones (which should respectively lead to higher profits). Consequently, the share of pharmaceutical costs in the national healthcare spending in Georgia is much higher compared to European states.
    Impact on Standard Treatment Costs:
    • There has been a decreasing trend in the standard treatment price for the past three years;
    • In 2011 standard treatment costs decreased more in case of treatment by brand-name medicines compared to treatment by generic products, however the treatment by generic medicines requires less spending because of low retail price of such medicines.
    The survey of prices and availability of medicines was divided into three phases and conducted in Georgia in 2009-2011. The first and third stags were financed by the World Bank, while the second one – by the Open Society Institute.CIF presents the results of the study exploring “Price, availability and affordability of medicines in Georgia”.

    Study presentation and small study report (available in Georgian).

  • Prices, Availability and Affordability of Medicines in Georgia-the New Study Report Endorsed

    In December 2010 CIF wrapped up the second stage of the study exploring “Price, availability and affordability of medicines in Georgia”.

    The study aimed at increasing awareness of civil society and improved access to medicines for the population through strengthening respective evidence. Field works during the first stage of the study were conducted in December 2009, while the second phase in July 2010. During the second phase the research covered four Georgian regions involving 146 pharmacies.

    The present report “Price, availability and affordability of medicines in Georgia” attempted to obtain reliable data on these aspects and documents tendencies of change over the course of 6 months in 2010. The survey looked at availability and price of Innovative Brands and their equivalent low price generics, analyzed collected data by type of medicine, regional differences as well as by type of pharmacy. The survey also looks at medicine mark-ups and compares with mark-ups in European countries, measures affordability of standard treatments as percent of average subsistence monthly allowance and provides comparison of the standard treatments by innovative brands and equivalent low price generics. Though the study has not covered all therapeutic categories, these do not detract from the importance of the above results as basis for action and as baseline for future studies.

  • Prices, Availability and Affordability of Medicines

    The present report   “Price, availability and affordability of medicines in Georgia” attempted to obtain reliable data on these aspects and documents tendencies of change over the course of 6 month in 2010. The survey looked at availability and price of Innovative Brands and their equivalent low price generics, analyzed collected data by type of medicine, regional differences as well as by type of pharmacy. The survey also looks at medicine mark-ups and compares with mark-ups in European countries, measures affordability of standard treatments as percent of average subsistence monthly allowance and provides comparison of the standard treatments by innovative brands and equivalent low price generics.  Though the study has not covered all therapeutic categories, these do not detract from the importance of the above results as basis for action and as baseline for future studies. Authors: Tamar Gotsadze, Natia Rukhadze, Tinatin Turdzeladze; 2010. The full version of the report in available in Georgian.

  • Opportunities for Change-Presentation

    The presentation describes the importance of the pharmaceutical sector, factors conditioned development of the draft Bill on Changes and Amendments to the Georgian Law on Drugs and Pharmaceutical Activities, which has been passed by the Parliament of Georgia 10th of August, 2009 and became effective from October 15, 2009. The presentation also describes key concepts, recommendations rendered to the Ministry of Labor, Health and Social Affairs in 2007, including the information on which recommendations accepted and which of them ignored by the Ministry; The presentation also provides recommendations for further improvement of the legislation. Author of the presentation: Vakhtang Megrelishvili. Full version is available in English and in Georgian.