Title: Analysis of European policy towards generic medicines
Other Titles: Analyse van het Europese beleid naar generieke geneesmiddelen
Authors: Dylst, Pieter
Issue Date: 12-Sep-2013
Abstract: Normal 0 21 false false false NL-BE X-NONE X-NONE <w:latentstyles deflockedstate="false" defunhidewhenused="true" defsemihidden="true" defqformat="false" defpriority="99" LatentStyleCount="267"> /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-qformat:yes; mso-style-parent:""; mso-padding-alt:0cm 5.4pt 0cm 5.4pt; mso-para-margin-top:0cm; mso-para-margin-right:0cm; mso-para-margin-bottom:10.0pt; mso-para-margin-left:0cm; line-height:115%; mso-pagination:widow-orphan; font-size:11.0pt; font-family:"Calibri","sans-serif"; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:"Times New Roman"; mso-fareast-theme-font:minor-fareast; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:"Times New Roman"; mso-bidi-theme-font:minor-bidi;}This PhD-project carries out an analysis ofthe European policy towards generic medicines. A generic medicine is amedicinal product with the same qualitative and quantitative composition inactive substances and the same pharmaceutical form as the reference medicinalproduct (‘originator productÂ’), and whose bio-equivalence with the referencemedicinal product has been demonstrated by appropriate bio-availability studies.They possess that same quality, safety and efficacy compared to originatormedicines at prices which tend to be 20-80% lower than their originatorequivalents. Part 1 of this project, the GeneralIntroduction, provides the definitions related to generic medicines andpresents an overview of the substantial savings which countries have obtainedthrough the use of them. Governments can implement a variety of policies toincrease the use of generic medicines, on both the supply- and the demand-side,which are described in Part 2 and Part 3.Studies on the supply-side have beenreported in Part 2. An overview of the regulatory framework regarding marketaccess of generic medicines in the European Union is provided in Chapter 2.1. Hurdles which delay marketaccess of generic medicines are listed: defensive patenting strategies; patentlitigations; patent linkage and third-party interventions during the process ofobtaining marketing authorization and pricing and reimbursement decisions; andbacklogs in national approval systems are well-documented causes for delayedmarket access of generic medicines. A list of recommendations to enhance marketaccess of generic medicines in the European Union round off this chapter (e.g. theestablishment of a unitary European Union patent and a unified and specialisedpatent litigation system at European level; automatic approval of pricing andreimbursement decisions upon marketing authorization; and a reduction ofbacklogs in national agencies).Chapter2.2 describes the current status and impact ofgeneric medicine pricing policies in Europe. Competition from Indian genericmedicine manufacturers, European variation in generic medicine prices andcompetition between generic medicine manufacturers by discount suggest that thepotential savings from generic medicines to health care payers and patients arenot fully realized in Europe. One solution might be to move away fromcompetition by discount to competition by price. Free-pricing systems may drivemedicine prices downwards under specific conditions. In price-regulatedsystems, regulation may lower prices of both originator and generic medicines,but it may also remove incentives for additional price reductions beyond thoseimposed by regulation. The European experience suggests that there is not asingle approach towards developing generic medicine pricing policies in Europe.A relationship between the market share ofgeneric medicines and the change of the price level of medicines in off-patentmarkets was demonstrated in Chapter 2.3.Market volumes increased in both high and low generic market share countries.Market values, on the other hand, decreased substantially in high genericmarket share countries while the decrease in low generic market share countrieswas limited. Medicine prices in high generic market share countries decreasedsubsequently more than prices in low generic market share countries.A survey was designed to assess thefeatures of tendering programs for outpatient prescription pharmaceuticals inEuropean countries, as described in Chapter2.4. Tendering is the acquisition of pharmaceuticals based on a competitivebidding process where the contract is granted to the pharmaceutical supplierswho offered the best bid following strict criteria. Only seven Europeancountries had adopted tendering programs for pharmaceuticals in ambulatory carein 2011. Tendering was more popular in countries with a mature genericmedicines market than in countries with a developing generic medicines market.A legal basis, criteria to grant the tender, the number of winners and theduration of the tender were amongst the crucial features for the programs towork. Some countries have achieved short-term savings on their pharmaceuticalbudgets, which was the main objective of tendering. There are however someproblems allied with the policy and the effects in the long term are stillunclear.An analysis of the impact of referencepricing systems in Europe rounds off Part 2, as described in Chapter 2.5. A reference pricing systemestablishes a common reimbursement level or reference price for a group ofinterchangeable medicines, i.e. the reference group. Many European governmentshave introduced a reference pricing system to contain pharmaceuticalexpenditures by controlling the level of reimbursement. Reference pricingdrives down prices of drugs subject to it, but not always below the referenceprice. The use of medicines priced at or below the reference price increased andsavings on pharmaceutical expenditure were generated, albeit that they tend tobe limited to the short term. The long-term growth of drug expenditure did notseem to have reduced by reference pricing. No negative effect on healthoutcomes of patients was observed.Part 3 groups studies which have beenperformed on different aspects of the demand-side. Chapter 3.1 provides a general overview of demand-side policieswhich have been implemented by European governments to encourage the use ofgeneric medicines. A plethora of different demand-side policies has alreadybeen initiated by different authorities, thereby targeting physicians,pharmacists and patients. The results have shown that positive knowledge andperceptions of generic medicines by physicians, pharmacists and patients arenecessary prerequisites to increase the use of generic medicines. Governmentsmust subsequently initiate appropriate policies to achieve this (e.g. academicdetailing programs and continuous medical education events for physicians andpharmacists and media campaigns for all stakeholders). These policies should becombined with policies to increase all stakeholdersÂ’ financial responsibilityto the healthcare system and policies to facilitate the prescribing anddispensing of generic medicines. Belgium has implemented a policy in 2006 whichobliges physicians to prescribe minimum quota of cheap medicines, as describedin Chapter 3.2. All groups ofgeneral practitioners, specialists and dentists reached their minimumpercentages yearly from 2006 until 2009. The percentage of cheap medicines (indefined daily doses) increased from 22.9% in January 2005 to 44.2% of allprescribed medicines in ambulatory care in December 2009. The percentage ofgeneric medicines increased from 12.10% in 2004 to 24.03% of all prescribedmedicines in ambulatory care in 2008. The policy of prescribing quota for cheapmedicines was not only associated with an increased prescribing of genericmedicines during 2004-2008, but also increased the prescribing of originalmedicines whose price had dropped to the reference price level, as thesemedicines were included in the definition of cheap medicines. The potential forprescribing generic medicines has not yet been fully met in Belgium. Despitethe success of the policy, adjustments are desirable, especially with respectto the broad definition of cheap medicines.Pharmacists play an important role in thedevelopment of a generic medicines market. It is important that they are not financiallypenalized for dispensing generic medicines, which is currently the case in someEuropean countries, as demonstrated in Chapter3.3. Therefore, their remuneration should move towards afee-for-performance remuneration instead of a price-dependent remuneration,which is currently employed in many European countries. A fee-for-performanceremuneration would provide a stimulus for dispensing generic medicines, aspharmacists would not be financially penalized for dispensing them.Chapter3.4 rounds off Part 3 with calculations of possiblesavings through an increased use of generic medicines by elderly, as they arethe biggest users of medicines. The analysis showed that these savings wererather limited (4.48% when the generic market share by volume increase to 95%).The full potential of generic medicines in the elderly population has not yetbeen realized in Belgium, due to the limited use of them and their relativehigh prices compared to their originator equivalents. The Belgian governmentshould implement additional incentives for physicians, pharmacists and patientsto increase the use of generics by elderly. These policies should be combinedby policies to lower prices of generic medicines and policies to rationalizethe prescribing of medicines for elderly, which should decrease the volume ofmedicines used by elderly subsequently.An analysis of the Spanish genericmedicines market is provided in Part 4.Spain is a highly decentralized country with 17 Autonomous Communities. Fundingand management of health care services, including pharmaceutical policies, isdecentralized and the responsibility of the regions since January 2002. The useof generic medicines in Spain is low compared to other European countries, bothin volume and value. We have provided an overview of the Spanish genericmedicines market and identified hurdles which impede its development.Recommendations o increase the sustainability of the Spanish generic medicinesmarket are proposed.Recommendations to increase the use of genericmedicines in Europe are proposed in the GeneralDiscussion in Part 5. These suggested policies are likely to work in allcountries throughout Europe, as they are policies which work independently ofthe different country-specific characteristics of health care systems. Theimpact of hospital policies regarding generic medicines is discussed, as thesedecisions may impact the future medication schemes in ambulatory care. Thechanging industrial landscape for pharmaceutical companies, with a tendency to pharmaceuticalcompanies combining both originator and generic divisions and the rise ofbiopharmaceuticals and biosimilars, is also discussed. Future research shouldfocus on the development of generic medicines in emerging markets andcountry-specific analyses of other European countries with limited use ofgeneric medicines.
Publication status: published
KU Leuven publication type: TH
Appears in Collections:Clinical Pharmacology and Pharmacotherapy

Files in This Item:
File Status SizeFormat
Thesis - final.pdf Published 2440KbAdobe PDFView/Open Request a copy

These files are only available to some KU Leuven Association staff members


All items in Lirias are protected by copyright, with all rights reserved.