France Pharmaceutical Market

8/9/2019 France Pharmaceutical Market

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FranceFrance

PharmaceuticalPharmaceuticalMarketMarket

Presented by:Presented by:

Ansu Archana (4) Ansu Archana (4)

Suchitra Devarajan (14)Suchitra Devarajan (14)

Resham Hira (24)Resham Hira (24)

Kumar Saurabh (34)Kumar Saurabh (34)

Rajul Pasrija (44)Rajul Pasrija (44)

Shalini Singh (54)Shalini Singh (54)



Ma rket OverviewMa rket Overview

T he French pharmaceuticals market generated total revenues of T he French pharmaceuticals market generated total revenues of USUS $42.35$42.35 Billion in 2009Billion in 2009, representing a compound annual growth, representing a compound annual growth

rate (CAGR) of 3.2% for therate (CAGR) of 3.2% for the period 2005period 2005- -20092009..

Other ther ap euticp ur po ses

35%

C a rdi o v a scul a r18%

Centr a l Nerv ous

System17%

Aliment a ry/ M et a b o lism13%

Res p ir a to ry9%

Onc o log y8%

Ther ap eutic Se g ment (% sh a re'2009:by V a lue)



Others includeOthers include

IpsenIpsen, Merck & Co. and 300 other small players, Merck & Co. and 300 other small players

Astr aZ enec a PLC5%

Pfizer Inc5%

N o va rtis5%

Sa n ofi Aventis10%

Servier11%

Gl axo SmithKline Plc

5%

Others59%

Le a din g C o m pa nies (% sh a re·2009:by V a lue)





Re g ul a to ry Re g imeRe g ul a to ry Re g ime

MainMain regulatory authorityregulatory authority is is the Ministry of Health, Youththe Ministry of Health, Youth & & Sport.Sport.

All All products mustproducts must be authorisedbe authorised by the Healthcare Products Safetyby the Healthcare Products Safety Agency (AFSSAPS Agency (AFSSAPS). ).

Average Average registration times vary betweenregistration times vary between 6 to 12 6 to 12 monthsmonths, , By 2011, theBy 2011, thebodybody is targetingis targeting 90 days for newly licensed drugs90 days for newly licensed drugs. .

In 2005In 2005, , AFSSAPS created a AFSSAPS created a unit tounit to monitor drug safetymonitor drug safety after marketingafter marketingapproval, with newapproval, with new checks on promotional material and patientchecks on promotional material and patientinformationinformation. .

AFSSAPS AFSSAPS increased the transparencyincreased the transparency by by announcing that itannouncing that it would publish would publish

committee proceedings on the Internet.committee proceedings on the Internet.



Intellectual Property DevelopmentIntellectual Property Development

W TO Member and T RIPS compliance.W TO Member and T RIPS compliance.

Patent protection as per EU and International Standards.Patent protection as per EU and International Standards.

IP Issues:IP Issues:

1.1. Cost containment measuresCost containment measures

2.2. Aggressive promotion of generic medicines Aggressive promotion of generic medicines

3.3. Government price cuts and unrealistic healthcare budget forGovernment price cuts and unrealistic healthcare budget forinnovative productsinnovative products

4.4. Concern about Generics being approved before patentConcern about Generics being approved before patentexpiryexpiry



Pricing and Reimbursement IssuesPricing and Reimbursement Issues

F r a nce Reimbursement C a te go riesF r a nce Reimbursement C a te go ries

Reimbursement Category ReimbursementRate (%)

Characteristic of Category

Pharmaceuticals for severe andchronic disease

100 Special list approved byMinister of Health

Pharmaceuticals for serious disease 65 Normal rate approved by

UNCAMPharmaceuticals for moderatelyserious disease

35 Rate determined byUNCAM

Pharmaceuticals pending de-listing 15 Temporary rate decided by UNCAM

N egotiation of price of reimbursable medicines betweenmanufacturers and the government committee, the Centred·Etude et de Prospective Stratégique (CEPS) de France.



ST RENG THS

1) One of the largest pharmaceutical marketsin the world.2) One of the leading per-capita spenders inEurope3) Sanofi-Aventis, one of the world¶s largestfirm, is based in France.4) Base for many major MNCs, like Pfizer.5) France¶s regulatory environment, based onEU directives

W EAKNE SS

1) Market growth in France has come under pressure due to govt. cost cutting measures.2) Parallel exports3) Local R&D activity is on the decline4) Reforms of drug reimbursement levels -

poorly received by consumers & industry.5) Rising prices of some OTCs because of liberalization of their sales, hampering patientaccess

OPPORTUNITIES

1) Potential for generics marketgrowth, as the government expands cost-containment and increasing number of patent expirations

TH REA TS

1) Govt.¶s cost-cutting policy2) Cost-cutting reforms± low MNC investment3) A continued decline in local R&D4) Government targeting overprescribing of some medicines to hamper volume increases.

5) Current economic difficulties to negativelyimpact consumer spending on medicines.

SWOTOPPO R TU NI T IE S

1) Potential for generics market growth, as thegovernment expands cost-containment andincreasing number of patent expirations2) Reimbursement of OTCs by insurance firms3) Ageing population - chronic treatments

SWOT





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France Pharmaceutical Market