Category Archive for "Pharmaceutical sector"

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.

 

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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.

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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).

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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).

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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).

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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.

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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.

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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.

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A New Paradigm for Regulating Georgian Pharmaceutical Market

Curatio International Foundation in partnership with UK-Georgia professional Network (UGPN) conducted policy club discussion to increase awareness of the civil society organization regarding the 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 is effective from October 15, 2009. The draft Bill has been developed with the technical support of the CIF consultants under the auspices of the USAID funded CoReform project and has been modeled on procedures already in place in Europe. Therefore, the Bill introduces completely new approaches to the drug market regulation procedures in Georgia. The proposed new regulatory environment is expected to simplify drug registration procedures, improve access to safe drugs and promote market competitiveness.

The demand for the Bill has been created by the fact that the share of imported drugs amounts to almost 90% in Georgian drug market, therefore, it became pivotal for GoG to pay special attention to import regulation and apply adequate instruments. For that reason policies relating to drugs and pharmaceuticals have increasingly been in spotlight in 2007 and 2008. The policy club discussion was organized in the framework of the “Strengthening Civil Society Capacity to Promote Research Evidence for Policy Development in Georgia” project aiming at building the skills of civil society organizations on improved provision of the evidence in policy making process. The project is implemented by the Curatio International Foundation with the financial support of Alliance for Health Policy and Systems Research (AHPSR) and Open Society Georgia Foundation (OSGF).

Mr. Vakhtang Megrelishvili the lead CIF expert in 2007-2008, who assisted the GoG in draft Bill development, made a presentation for the civil society organizations covering the following important issues: a)background information; b) why the need for creation of a new regulatory environment for the pharmaceutical market has emerged; c) recommendations provided by the CIF experts to the GoG for improvement for the drug market regulation; d) excepted and rejected by the government recommendations; e) expected impacts of the Bill on the Georgia pharmaceutical market.

The civil society organization expressed their interest and willingness to participate in the Bill execution monitoring process to observe how the Bill will affect pharmaceutical market.

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