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  • A Study Of Drug Price Control Mechanism In Various Countries

  • 1M.Pharm Scholar Department of Pharmacy Practice, National Institute of Pharmaceutical Research and Education, S A S Nagar, (Punjab).

    2Associate Professor, M. Pharm., Ph.D., Department of Pharmacy Practice, National Institute of Pharmaceutical Research and Education, S A S Nagar, (Punjab)

Abstract

Introduction: This study aims to study the price control mechanism in countries like Australia, Germany, France, Canada and United Kingdom for providing affordable help to the masses and documenting there experiences in providing affordable public health and there significance in Indian perspective. Method: A literature search was made in search engines like PUBMED, SCIENCE DIRECT, EPNET, HIGHWIRE PRESS etc using search terms like “drug prices”, “Pricing strategy”,” Price control mechanism”, “affordability measures” etc. the papers obtained were analyzed and there observations were recorded and results were presented in form of Table. Key Findings: Among the various price control measures adopted by various countries some prominent measures are Reference pricing, Parallel Importing, Restriction in marketing and pricing approvals and barriers related to prescribing and dispensing like restrictive formulary ,prescribing budgets are being adopted by various govt. for control of the pharmaceutical expenditures . Conclusion: This Study Provides the insight into the various price control mechanism and affordability measures adopted by various countries across the globe and there experience in implementing them.

Keywords

Drug Pricing, Price Control Mechanism, Pharmaceutical Pricing, Pricing Strategies, Affordability, Reference Pricing, Parallel Importing, Pharmaceutical Expenditure

Introduction

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Medicines play a crucial role in saving lives, restoring health, and preventing diseases and epidemics. In India Indian constitution directs  Govt. of India to provide heath services to every citizen of India. In recent years with implementation of new patent regime after 2005 as per obligation of Indian government to the WTO, there are speculation of rise in prices of drugs post TRIPS. In this regard there is a need to study price control and affordability measures adopted across the globe to provide easy access to people to essential medicines after TRIPS failing which the access of essential drugs to common people might become difficult. National drug expenditure as a proportion to total health expenditure ranges from seven per cent to 66 per cent worldwide. The proportion is higher in developing countries (24-66 per cent) than in developed countries (8-30 per cent). In India it is Close to 35 percent. Even then 30 percent of the world’s population lacks regular access to essential medicines and in our country it is as high as 65 percent. In many high-income countries, large proportion pharmaceuticals are publicly funded or have social insurance or other reimbursement scheme. In low and middle-income countries including India, public medicine expenditure does not cover the basic medicine needs of the majority of the population. In these countries, patients pay for 50-90 per cent of the medicines from their own pockets1                                  

So the medicine costs are born by consumer, which can dominate household’s health spending, at over 80 per cent of the total. With increase in costs of treatment for TB, HIV/AIDS, malaria, and bacterial infections, healthcare make them unaffordable. India being a socialist country, decided to control the prices of almost all medicines as early as in 1970 through the Drug Price Control Order (DPCO). With successive liberalized policy of various governments, the number of drugs under the price control has declined from all drugs in 1970 to just 73 in 1994. With implementation of new drug policy, Pharmaceutical Policy-2002, it was planned to bring down the number further, to have as low as 30 drugs under price control.

Health is a fundamental human right. Constitution of India directs the state to regard  the improvement of public health as among its primary duties five year plans have been providing  the framework within which the center and state have developed there health services. Since the attainment of independence considerable progress has been made in the promotion of heath status to the public-as reflected in the eradication /control of diseases like small pox, malaria etc. reduction in mortality rates rise in expectancy creating of a fairly extensive network of health care institution and the availability of large stocks of medical and health professionals .

Drug alone are not sufficient to provide healthcare. However if rationally used, they do play an important role in protecting, Maintaining and restoring the health of the people and in controlling population .The Pharmaceutical industry has therefore a vital role in serving  the basic health needs of the people .

Reference price system for pharmaceutical benefit programmes have received increasing attention in recent years this mechanism controls the fraction of price of drug to be reimbursed to the patient. . Health insurance systems in various countries have experimented in recent years with this novel form of patient cost sharing called “reference pricing.” Under this approach, the insurer covers only the prices of low-cost, reference drug in therapeutic clusters that are deemed to be close substitutes for one another in treating specific illnesses. Patients who desire a higher-price substitute in a cluster must then pay the full difference between the retail price of that drug and the reference price covered by the insurer one type of reference price is employed by the Australian government i.e. Pharmaceutical benefit scheme (PBS) in Australia.2.3., Many countries, including Australia regulate the price consumer pay for pharmaceutical. The Pharmaceutical benefit scheme in Australia is a multistage game played between the to go through the drug evaluation, regulation bargaining and regulation process for a particular drug. In first stage of the game firm chooses whether or not to increase the price. In second stage the regulator evaluates the regulator and pharmaceutical firms for quality of drug submitted for evaluation. In third stage the regulator decides which firms to regulate .The fourth stage involves the bargaining between the regulator and the regulated firm over the reimbursement to be made to firms are to receive in return of selling there drug at regulated price to consumer .In fifth stage firms compete in drug market and the regulated price is with there decision. 4, 5, 6, 7.

METHODS

This study is a price composition analysis done to see the actual changes in the various components of drug price like excise duty ,VAT ,TRIPS etc. and to find out factor responsible for change in the price of the drug and to categorized drug according to the factor responsible for change in price.  This study was done on 100 drugs selected from the National Essential Medicine list based on there usage data and there formulation and strength taken as given in the NEML. Three price value has been taken for each formulation a Highest Price, a lowest price and a Medium price (average of highest and lowest) and medium price is taken for the further study .Price of bulk drug and formulation has been recorded for a period of 2yrs from July 04-July 06 and there difference is recorded .The variation in the difference of price been recorded and drugs are being categorized on the basis of factor responsible for changes in price of drugs like excise duty, VAT etc. The price data of formulation is been taken from CIMS and bulk drug price is taken from Pharmapulse July04-July06 of respective month.

Literature review is collected about the various measure taken by different government to make drug affordable to there masses and price controls measures adopted in various countries.

Results

Result of the study shows a price increase in the price of following drugs  Diazepam, Diclofenac, Phenytoin, Amikacin, Atenolol, Domperidone ranging from 109%-145% and  a price decrease of 57 % in the Prices of Azithromycin .and the prices of other drug are  found to remain same.

Table1 Reference Price how when and where?

SR NO

Country

Year

Launched

Criterion for Setting of the RP

1

Germany

1993

Statistical Average Price of Medicine in a Category

2

Australia

1998

Lowest Price Medicine

3

Netherlands

1991

Average Price of Medicine in category

4

New Zealand

1992

Lowest Price Medicine

5

Denmark

1993

Average unit price of two lowest cost drug  in a group

6

Norway

1993

Lowest Priced Product  +5%

7

Sweden

1993

Lowest Priced Medicine +10%

8

Canada

1995

Lowest Price Medicine

9

Spain

2000

10-50 %lower than the highest price in group

10

Italy

2001

Weighted average of all generic prices of group

11

Portugal

2003

Most Expensive Drug

12

France

2003

Generic Prices

Table 2 Various Approaches Adopted by Various Government for Price Control.

S.No.

EU Country

Cost Effective Pricing

Fixed Pricing

Reference

Price

Free Pricing

1

Austria

-

-

-

  •  

2

Belgium

-

  •  

-

  •  

3

Denmark

-

-

  •  

-

4

Finland

  •  

-

-

-

5

France

  •  

-

-

-

6

Germany

-

  •  
  •  

-

7

Greece

  •  

-

-

-

8

Ireland

  •  

-

-

-

9

Italy

  •  

-

-

-

10

Luxemburg

  •  

-

  •  

-

11

Nether land

  •  

-

-

-

12

Portugal

  •  

-

-

-

13

Spain

  •  

-

  •  

-

14

Sweden

  •  

-

-

-

15

United states

  •  

-

  •  

-

Literature review regarding the approaches adopted by various countries for making drugs affordable is recorded various options taken by various government are: Reference pricing, Approval delays (delay in Marketing and Pricing approvals), Barriers to Dispensing and Prescribing (Restrictive formularies, Prescribing guidelines, Prescribing               budgets      , obstacle to promotion ) and Parallel import are some major methods adopted by various government for pricing controls and making drug affordable for masses .

Marketing approval is required for the sale of all pharmaceutical. The process typically involves multiple stages of approval and multiple government and regulatory bodies. The requirements delay market access and jeopardize intellectual property protection The pricing approval decision (or reimbursement decision) suffers from many of the same difficulties as the marketing approval decision. Manufacturers are typically required to submit scientific dossiers and economic reports and, in some cases, price dat The pricing decision may also be delayed by extensive negotiations, waiting periods, multiple decision-making stages, and lengthy Parallel trade occurs when a product covered by intellectual property rights sold by or with the rights holder consent in Nation A and is resold in another Nation B without the right holders authoritization The incentive for its occurrence is a sufficient difference in prices between the price paid by first purchaser and the prices charged in Nation B to cover shipping and other transaction cost and still offer gains to both the shipper and the Nation B buyer.

Parallel import is one major method for availability of medicine s to developing countries. Parallel trade in patented articles is legally Permissible under what is called the doctrine of exhaustion. This doctrine states that once the producer of patented Product or its agent has sold its product in good faith to an independent party, the patent holder’s right to determine the conditions under which the product is resold is exhausted if there is price difference among customers of the original manufacturer, any customer can engage in arbitrage transaction that exploit those differences. There is controversy over the right of patent holder to limit parallel trade in its product across national borders.

Discussion

This study determines the variations in the price of drug because of various components of the price. Price data is available for 100 drugs and rise in price is recorded in range of 109%-145% for drugs Diazepam, Diclofenac, Phenytoin, Amikacin, Propanolol, Atenolol, and Domperidone. Price decrease of 57% is found in azithromycin for rest drug the prices have remained the same. The prices of majority of other drugs have remain unchanged during this period .Regarding the various affordability measures taken by various government like Reference Pricing by Germany  which has  proven not successful alone other method like approval barriers ,barriers to prescribing are been successfully used . One another method of parallel import is being used by several countries under the doctrine of exhaustion of patent rights. Parallel import is being made legal by some countries in Latin America.

CONCLUSION

In the present study 100 drugs are being taken for study and there price data recorded .under the speculation of price rise in country only 7 drug out of 100 has shown price rise while rest has shown no price changes and one has shown price decrease. This study shows no significant  impact on the prices of the drugs.

 

 

REFERENCES

  1. World Health Organization. The World Medicine Situation: a report New York: World Health Organization office, 2004.
  2. Wright D J. The Drug bargaining game. Pharmaceutical regulation in Australia. Journal of Health Economics 2004; 23:785-813
  3. Harvey K J. The Pharmaceutical Benefit Scheme 2003-2004.Australia and New Zealand health policy 2005:2:2
  4. Mestre J, Fernandez. Reference Prices and generic medicine: what can we expect? Journal of Generic Medicine. 2003:1 (1): 31-38:
  5. Barak A. Pharmaceutical Pricing overview of Impact of Generictization. Journal of Generic Medicine. 2003; 1 (1): 21-30.
  6. Dickson M, Redwood H. Pharmaceutical reference prices? How do they work? Pharmacoeconomics 1998; 14(5): 471-479.
  7. Loannides Demos LL, Ibhrahim J E, McNeil J J. Pharmaceutical based Reference Pricing Scheme effect on pharmaceutical expenditure, Resource Utilization and Health Outcomes. Pharmacoeconomics 2002; 577-591.
  8. Bloor K, Maynard A , franmantle M. Lesson from international experience in controlling pharmaceutical expenditure. BMJ 1996; 313:33-35.
  9. Kalner G D J, Glavin P J. International pharmaceutical spending controls France, Germany, Sweden and United Kingdom. Health Care Finance Rev. 1994; 15 (13): 127.
  10. Schneewies S, soumerai S B, Robert J Glynn, Maclure M, Darmoth C, Walker A M. Impact of reference based pricing of Angiotension Converting Enzyme Inhibitors on drug utilization. CMAJ 2002; 166(6): 737-744.
  11. Grootendorst P R,  Dolovich L, Bernie J O’Brian, Holbrook A M, Levi A R. Impact of reference based pricing of nitrates on the use and cost of Antianginal Drugs.CMAJ 2002; 165(8): 1011-1019.
  12. Sebastian S, Stephen B soumerai,  Glynn R J, Maclure M,  Darmoth C ,  Walker A M. Outcome of Reference Based Pricing of Angiotension Converting Enzyme Inhibitors.   NEJM 2002; 346 (11): 822-829.
  13. Rothberg AD, Blignaut J Serfortin CB, Valodia B, Fekhaut S, Pels LM. Experience of Medicines Reference Pricing Model. S Afr. Medical Journal 2004; 94(3): 183-188.
  14. McGregor M. Coverage of drug costs: Reference Based Pricing. Canadian Journal of Cardiol 1998; 14(5): 666-668.
  15. Towse A. The Efficient use of Pharmaceutical: does Europe have any lessons for a Medicare drug benefit. Health Affairs 2003; 22 (3): 42-45.
  16. Marine L, Sementherajah M, Smith T. Evaluating reference based pricing initial findings and prospects. JMAC 1999; 161(3): 286-288.
  17. Kanavos P, Reinhardt U. Reference based pricing for drugs is it compatible with U.S. Health Care? Health Affairs.2003; 22(3): 16-30.
  18. Huttin C. Experience with reference pricing. International Journal of Risk and safety in medicine 2002; 15:85-92.
  19. Carrin G, Vongehaii P H. Provider Payments and Patient charges as policy tools for cost containment. How useful are they in high-income countries? Health resources for health 2003; 1:1-10.
  20. Pavchnik N .Do pharmaceutical prices respond to patient out of pocket expenses. Rand Journal of Economics 1994:33(3): 469-487.                                                                                                                                  
  21. US Department of commerce, International Trade Administration .Pharmaceutical Price controls in OECD countries implications for US consumer Pricing Research and Development and Innovation .Washington D C, 2004.  
  22. Scherer F M, Watal J. Post TRIPS options for Access to Patented Medicines in Developing Countries a working group paper of Commission on Macroeconomics and Health.2001.20 (9):577-59.
  23. Danzon P M. The Economics of Parallel Trade. Pharmacoeconomics 1998; 13(3):293-304.
  24. James J H, Shah ND, Vermuelen L C, Hunkler R J, Hontz K M. Projecting future drug expenditure. Am. J. Health Sys. Pharmacy 2005;15:   
  25. Walker D. Cost and cost effectiveness of HIV AIDS Prevention strategy in developing country. Is there an evidence base? Health Planning and Policy 2003; 18(1): 4-17.
  26. Elner A. Rethinking prescribing in United States. BMJ 2003; 327: 1397-1400.
  27. Thakre M B, Topale P, Malluwar V R, GoKhale H V. Critical Need of Patent Education in Post Graduate Research Scholar. IJPE .2002.
  28. Mrazik M F. Comparative Approaches to Pharmaceutical Price regulation in European Union. Croat Medical Journal 2002:43(4): 453-461.
  29. King D R. Kanavos P. Encouraging the use of Generic Medicine Implications for Transition Economies. Croat Medical Journal 2002; 43 (4): 462-469.
  30. Canberra B B. Australia amends its free trade deal with US to lessen effect on drug costs. BMJ 2004; 329:420.
  31. Silvia M E, Schneewies S, Thomas D S. Pharmacoeconomics 2003; 21 (2):89-103

Reference

  1. World Health Organization. The World Medicine Situation: a report New York: World Health Organization office, 2004.
  2. Wright D J. The Drug bargaining game. Pharmaceutical regulation in Australia. Journal of Health Economics 2004; 23:785-813
  3. Harvey K J. The Pharmaceutical Benefit Scheme 2003-2004.Australia and New Zealand health policy 2005:2:2
  4. Mestre J, Fernandez. Reference Prices and generic medicine: what can we expect? Journal of Generic Medicine. 2003:1 (1): 31-38:
  5. Barak A. Pharmaceutical Pricing overview of Impact of Generictization. Journal of Generic Medicine. 2003; 1 (1): 21-30.
  6. Dickson M, Redwood H. Pharmaceutical reference prices? How do they work? Pharmacoeconomics 1998; 14(5): 471-479.
  7. Loannides Demos LL, Ibhrahim J E, McNeil J J. Pharmaceutical based Reference Pricing Scheme effect on pharmaceutical expenditure, Resource Utilization and Health Outcomes. Pharmacoeconomics 2002; 577-591.
  8. Bloor K, Maynard A , franmantle M. Lesson from international experience in controlling pharmaceutical expenditure. BMJ 1996; 313:33-35.
  9. Kalner G D J, Glavin P J. International pharmaceutical spending controls France, Germany, Sweden and United Kingdom. Health Care Finance Rev. 1994; 15 (13): 127.
  10. Schneewies S, soumerai S B, Robert J Glynn, Maclure M, Darmoth C, Walker A M. Impact of reference based pricing of Angiotension Converting Enzyme Inhibitors on drug utilization. CMAJ 2002; 166(6): 737-744.
  11. Grootendorst P R,  Dolovich L, Bernie J O’Brian, Holbrook A M, Levi A R. Impact of reference based pricing of nitrates on the use and cost of Antianginal Drugs.CMAJ 2002; 165(8): 1011-1019.
  12. Sebastian S, Stephen B soumerai,  Glynn R J, Maclure M,  Darmoth C ,  Walker A M. Outcome of Reference Based Pricing of Angiotension Converting Enzyme Inhibitors.   NEJM 2002; 346 (11): 822-829.
  13. Rothberg AD, Blignaut J Serfortin CB, Valodia B, Fekhaut S, Pels LM. Experience of Medicines Reference Pricing Model. S Afr. Medical Journal 2004; 94(3): 183-188.
  14. McGregor M. Coverage of drug costs: Reference Based Pricing. Canadian Journal of Cardiol 1998; 14(5): 666-668.
  15. Towse A. The Efficient use of Pharmaceutical: does Europe have any lessons for a Medicare drug benefit. Health Affairs 2003; 22 (3): 42-45.
  16. Marine L, Sementherajah M, Smith T. Evaluating reference based pricing initial findings and prospects. JMAC 1999; 161(3): 286-288.
  17. Kanavos P, Reinhardt U. Reference based pricing for drugs is it compatible with U.S. Health Care? Health Affairs.2003; 22(3): 16-30.
  18. Huttin C. Experience with reference pricing. International Journal of Risk and safety in medicine 2002; 15:85-92.
  19. Carrin G, Vongehaii P H. Provider Payments and Patient charges as policy tools for cost containment. How useful are they in high-income countries? Health resources for health 2003; 1:1-10.
  20. Pavchnik N .Do pharmaceutical prices respond to patient out of pocket expenses. Rand Journal of Economics 1994:33(3): 469-487.                                                                                                                                  
  21. US Department of commerce, International Trade Administration .Pharmaceutical Price controls in OECD countries implications for US consumer Pricing Research and Development and Innovation .Washington D C, 2004.  
  22. Scherer F M, Watal J. Post TRIPS options for Access to Patented Medicines in Developing Countries a working group paper of Commission on Macroeconomics and Health.2001.20 (9):577-59.
  23. Danzon P M. The Economics of Parallel Trade. Pharmacoeconomics 1998; 13(3):293-304.
  24. James J H, Shah ND, Vermuelen L C, Hunkler R J, Hontz K M. Projecting future drug expenditure. Am. J. Health Sys. Pharmacy 2005;15:   
  25. Walker D. Cost and cost effectiveness of HIV AIDS Prevention strategy in developing country. Is there an evidence base? Health Planning and Policy 2003; 18(1): 4-17.
  26. Elner A. Rethinking prescribing in United States. BMJ 2003; 327: 1397-1400.
  27. Thakre M B, Topale P, Malluwar V R, GoKhale H V. Critical Need of Patent Education in Post Graduate Research Scholar. IJPE .2002.
  28. Mrazik M F. Comparative Approaches to Pharmaceutical Price regulation in European Union. Croat Medical Journal 2002:43(4): 453-461.
  29. King D R. Kanavos P. Encouraging the use of Generic Medicine Implications for Transition Economies. Croat Medical Journal 2002; 43 (4): 462-469.
  30. Canberra B B. Australia amends its free trade deal with US to lessen effect on drug costs. BMJ 2004; 329:420.
  31. Silvia M E, Schneewies S, Thomas D S. Pharmacoeconomics 2003; 21 (2):89-103

Photo
Pankaj pant
Corresponding author

M.Pharm Scholar Department of Pharmacy Practice, National Institute of Pharmaceutical Research and Education, S A S Nagar, (Punjab).

Photo
Dr .P.Tiwari
Co-author

Associate Professor, M. Pharm., Ph.D., Department of Pharmacy Practice, National Institute of Pharmaceutical Research and Education, S A S Nagar, (Punjab)

Pankaj Pant, Dr .P.Tiwari , A Study Of Drug Price Control Mechanism In Various Countries, Int. J. of Pharm. Sci., 2026, Vol 4, Issue 8, 4197-4205. https://doi.org/ 10.5281/zenodo.22095881

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