cofepris: using regulation to better protect the … · in the verification units; they also...

COFEPRIS: Using regulation to better protectthe population’s health and

transform the market.

The Case of Mexico

September 2016

COFEPRIS is an agency with broad regulatory powers, which main activity is the prevention againstsanitary risks. It is related with industries that represents 9.8% of GDP, and 10.94% of foreignMexican trade.

Regulated Sectors by COFEPRIS

Regulated Sectors1. Food and beverages

2. Health supplies

3. Health services

4. Emergences

5. Pesticides, Vegetable nutrients and Toxic substances

6. Cosmetics and beauty products

7. Environmental Risks8. Labor Safety and Health

Marketing

Imports

Exports

Advertising

Retail and Suply

Production

Distribution

3

The value of the products regulated by COFEPRIS represents 9.8% ofMexican GDP.

-

100

200

300

400

500

600

700

Industria Alimentaria Industria Tabaco yBebidas

Industria Farmacéutica Industria química Fabricación deFertilizantes, pesticidas

y otro agroquímicos

Fabricación MaterialDesechable de uso

médico, dental,oftálmico

624

237

151 139

24 10

Billio

ns

Industries Regulated by COFEPRIS(2009 last available year)

COFEPRIS regulates 44 cents out of every peso spent by households in Mexicothrough 3 categories: Food, beverages; health care; and personal care products.

34.0%

2.5%

7.3%

56.2%

Household Expenditures per Category(as a % of total household expenditures)*

Food, beverages and tobaccoHealth care productsPersonal care productsOthers

Source: Encuesta Nacional de Ingresos y Gastos de los Hogares (ENIGH, 2012). INEGI (2013).* Only current monetary expenditures are considered.

5

COFEPRIS regulates about 11% of the total trade flow between Mexico and the rest of theworld (64% of GDP).

Source: DEOI with data from Banco de Mexico (2014).

0

0.5

1

1.5

2

2.5

3

3.5

Instrumentos yaparatos de

óptica ymédicos

OtrosProductos

Alimentarios yDerivados de

MateriasPrimas

Productosquímicos

orgánicos einorgánicos

Productosfarmacéuticos

Aceitesescenciales,

Jabon, Ceras,Lubricantes

Productos delas industrias

químicas

Carne ydespojos

comestibles

Bebidas yvinagre

Leche,lácteos,

huevos y miel

Pescados,crustáceos y

moluscos

Tabaco ysucedáneoselaborados

25,214 mdd

15,037 mdd

10,551 mdd

6,747 mdd 6,422 mdd5,394 mdd 5,142 mdd 4,732 mdd

2,200 mdd 1,421 mdd439 mdd

% o

f tot

al tra

deflo

w

6

Pharmaceutical Policy

Characteristics of pharmaceutical policy– Rests on four fundamental pillars

– The pillars are aligned with the 3 priorities of health policy established by the FederalGovernment.

– Its main objective is to improve access of the population to a well-supplied drug market thatoffers innovative and generic medicines at the best prices.

Pillars of Pharmaceutical Policy Government’s Health Policy Priorities

A regulatory agency that guarantees thesafety, quality and eficacy of all drugs.

1. Effective Access2. Service Quality

3. Prevention

A reliable scheme to authorize sanitary registrations.

Removal of barriers to market entry forproducts that are safe and of high quality.

Harmonization of the sanitary agency with bestinternational practices.

Evolution of the Mexican Pharmaceutical RegulationDuring this period the marketauthorizations for medicines hadindefinite duration and without the legalobligation to be bioequivalent.

1. The legal requirement of bioequivalence is implemented.

2. A netwrork of laboratories is created to perform bioequivalence tests through Authorized Third Parties.

2001 2005 2010

First SaniitaryRegistration issued

in Mexico

July 5COFEPRIS is

created

Reform to the National Health

Law

2012

PAHO recognizes

COFEPRIS as NRA of

Regional Reference

1920 2014

WHO declares

COFEPRIS a Functional

NRA

Domestic market with only two types of medicines: 1. Innovative Drugs2. Generics

Implementation of NationalHealh LawReform onrenewal of SanitaryRegistrations

2009

Enactment of theBiotechnologicalMedicines Act.

2011

SecondaryRegulations forBiotechnologyMedicines

Benefits of Authorized Third Parties• Third Parties issue a “Pre-dictamination” certificate, which must be submitted together with the

complete paperwork when filing for a New Registration, an Extension or a Modification to anexistent Registration to Cofepris.

• The “Pre-dictamination” certificate of Third Parties allow to reduce signifcantly the processingtime of each individual filing. For example, in the case of new registrations the processing time wasreduced by an average of approximately 2 years.

9

0.5

2

3.75

6

4.5

30

0 5 10 15 20 25 30

Trámite con Pre-dictamen

Trámite COFEPRIS


Trámite COFEPRIS


Trámite COFEPRIS

Modif

icació

nPr

órro

gaRe

gistro

Months

Type

of f

iling

Average processing time for filings of drug products (months)

10

Authorized Third Parties• There are 19 Authorized Third Party Companies currently in operation and 8,456 products have been

authorized in an average of less than 20 days.

• The following table shows the type of procedure, the total number of filings submitted and its compositionbetween approved and in process.

Filings submitted with Pre-dictamination of Authorized Third Parties

Procedure Number of Filings In process Approved

Medical DevicesNew Registration 3,342 410 2,931

Extensions 772 36 736

Modification 2,189 182 2,007

MedicinesNew Registration 715 95 592

Extensions 495 58 425

Modification 2,046 254 1,765

Total 9,559 1,035 8,456The approval of those registers have been achieved with a team of 105 evaluators in the verification units; they alsocontribute to the activities performed by the 141 evaluators from COFEPRIS, in order to increase the productivity in the issuing of registers.

Generics Policy

• The Mexican Government has released 37 active substances. This corresponds to491 new registrations of generic medications, which address 71% of Mexico´smortality causes.

• The Generics Policy of the Mexican Government has allowed an average reductionof 61% in medicines prices, which represents average savings of $1,047 pesos for theconsumer.

11

• There is no international record of a generics releasing strategy of such magnitud and ina reduced period of time.

Number of Packages

ReleasedSubstances

New GenericsOptions

AccumulatedSavings (billions of

dollars)

Mortality causes attended, as a % of total of deaths

AdditionalPatients

14 37 491 24,632 71% 1,998,202

Source: INEGI (2014).* Linezolid is a wide spectrum antibiotic used mainly in pulmonary diseases.

18.1

14.1

12.2

7.05.32.1

12.2

29.0

Causes of Mortality in Mexico(% of total of deaths)

Cardiovascular

Endocrinology

Oncology

Pulmonary

Neurology

Infectious and transmittable

Other generic medicines

Other diseases

AtorvastatineValsartan

ClopidogrelLosartan

IrbersartanTelmisartan

ImiquimodDocetaxel

GemcitabineBicalutamideAnastrozolPemetrexed

Zoledronic AcidTopotecánBortezomib

• With this increse in the supply of medications, the most frequent and costly diseases,which correspond with 71% of mortality causes in Mexico, are covered.

Pioglitazone

MontelukastCefepime

MometasoneLinezolid*

LamivudineAbacavir

MeropenemValganciclovir

EscitalopramDonepezilQuetiapineOlanzapine

13Source: COFEPRIS (2015).

Private MarketThe average reduction in prices of generics has been 61%, which represents an average saving of $1,047 pesos forthe consumer.

Reductionof 89% in price















0

1000

2000

3000

4000

5000

6000

Peso

s

Precio de Innovador (Promedio) Precio de Genérico (Promedio)Average

reduction in prices:$1,052

(Reduction of 62%)

Average price of innovator Average price of generics



Reductionof 54% in price Reduction

of 53% in price





of 46% in price


of 39% in price




0

2000

4000

6000

8000

10000

12000

14000

16000

18000

Peso

s

Precio de Innovador (Promedio) Precio de Genérico (Promedio) Averagereduction in

prices:$1,052

(Reduction of

• For example, treatments for cardiovascular diseases have decreased 89%, for oncologicaldiseases, 88%, and for diabetes mellitus, 86%.

Average price of innovator Average price of generics

Source: COFEPRIS (2015).

15Source: IMSS (2012, 2013) and COFEPRIS (2015).

Public Tender pricesPrice reduction of generics averaged 60%.The largest decreases are related with cardio vascular diseases (90%), Diabetes (91%) and oncological diseases (82%).







of 48% in price




of 19% in price


$0

$1,000

$2,000

$3,000

$4,000

$5,000

$6,000

Peso

s

Precio Promedio en Licitaciones Públicas del IMSS 2011Precio Promedio en Licitaciones Públicas del IMSS 2012

Averagereduction in prices: $440

(Reduction of 60%)

Average IMSS public auction price in 2011Average IMSS public auction price in 2012-2015

$87.00

$9.00 $5.32

$307.60

$31.40 $15.67$0

$50

$100

$150

$200

$250

$300

$350

Oncología Cardiovascular Diabetes

Price

sin

curre

ntUS

dol

lars

Price Comparison in the Generics Marketin Mexico and Central America (2014)*

México (current $US) Promedio Centroamérica (current $US)

Oncology

Average Central America

Price Comparison between Mexico and Central America• A comparison between the generics market of Mexico and Central America shows that medicine prices

are 71% lower in Mexico for drugs used for oncological and cardiovascular diseases.

• Moreover, medicines used in the treatment of type 2 Diabetes show prices that are 66% lower in Mexicothan in Central America.

Source: COFEPRIS (2015) with data from the pharmaceutical market in Mexico and IMS Health (2014).* The following countries are considered for Central America: Panama, Costa Rica, Honduras, Guatemala, El Salvador and Nicaragua. The following active substances were considered by therapeutic group: Oncology (Bicalutamide, Imiquimod and Gemcitabine); Cardiovascular (Atorvastatine, Clopidogrel, Valsartan, Irbesartan and Losartan); Diabetes (Pioglitazone).

Price Comparison between Mexico and South America• A comparison between the generics markets of Mexico and South America shows that, on average, the

prices of medicines for cardiovascular diseases are 55% lower in Mexico.

• Moreover, medicines used in the treatment of diabetes are 83% lower in Mexico than in South Americancountries.

Source: COFEPRIS (2015) with data from the pharmaceutical market in Mexico, Argentina, Brazil and Colombia (2014).* The following countries were considered for South America: Argentina, Brazil and Colombia.The following active substances were considered by therapeutical group: Oncology (Bicalutamide); Cardiovascular (Atorvastatine); Diabetes (Pioglitazone).

87

9 5.32

110.29

19.8130.71

0

20

40

60

80

100

120

ONCOLOGY CARDIOVASCULAR DIABETES

Price

s in

Curre

nt U

S Do

llars

Price Comparison in the Generics Market in Mexico and South America (2014)*

MEXICO CURRENT US AVERAGE SOUTH AMERICA CURRENT US

Innovation policyAgreement for the promotion of innovation

• The Mexican Government established an innovation policy relying on regulatory cooperation amongdifferent sanitary agencies in order to expedite the entry of new drugs to Mexico. This policy consists of:

1. Equivalence Agreements of new drugs with the US, Canada, Australia, Switzerland and theEuropean Union.

2. To encourage clinical research, Mexico substituted the requirement of a foreign free sale certificate witha report of clinical studies in Mexican population.

360300 290 270

220 203 180 180150

120 12090

60

0

100

200

300

400

Méxic

o (an

tes)

Cana

dá

Arab

ia Sa

udita

Sing

apur

Espa

ña

Austr

alia

China

Estad

os U

nidos

Reino

Unid

o

Arge

ntina

India

Bras

il

Méxic

o (co

nac

uerd

os)

Num

ber o

f Day

s

Days to Grant Registration for Innovative Drugs

19

Oportunity Cost (in million dollars) Regulatory Burden (%)

Benefits of the agreement on new moleculesBefore the agreement With the agreement

Decrease in opportunity cost of 40million dollars (500 million pesos). Reduction in regulatory burden

of 82%.

45 million dollars

7 million dollars 100%

18%

• The opportunity cost associated with the days a file is processed hasdecreased in approximately 40 million dollars (500 million pesos). This cost wasestimated in 45 million dollars (570 million pesos).*

• Further, with the equivalence agreement on new molecules, the regulatoryburden for each file decreases in 82%.

* Calculation of the opportunity cost consists of the daily administrative cost to process registrations for new molecules multiplied by thenumber of days requeried to grant authorization.

Agreement for thePromotion of Innovation

3

213

2010 2012-2015

Registros emitidos a medicamentos innovadores (2010-2016)

2012-2016

From 2012 to 2016, 213 sanitaryregistrations were issued. This representsan increase of 7,000%, compared to 2010

• As a result of the innovation policy, from 2012 to 2016, COFEPRIS issued 213 new marketingauthorizations for innovative medicines, treating 21 different therapeutical classesrepresenting 73% of mortality causes in Mexico.

• This represents an increase of 7,000% in the supply of medicines with respect to the 3 registrationsissued in 2010.

• .

Innovation Policy

$6,996$5,780

$2,316$745

$0$1,000$2,000$3,000$4,000$5,000$6,000$7,000$8,000

Región Centro Región Sureste Región Frontera México

Peso

s

Prices Comparison: Neumological Medicines*

(in pesos)

Before entry to the Mexicanpharmaceutical market

After entry to the Mexicanpharmaceutical market

* For cardiovascular medicines, the active substance Apixaban is considered. Transportation costs and time used to obtain the medicine are considered. • Central Region: Mexico City and its Metropolitan Area.• Southeast Region:Yucatan Península and Cancún.• Border Region: Includes the city of Tijuana.

Prices Comparison: Neumological Medicines• Before the entry of the drug Eklira Genuair (Aclidinium bromide) to the Mexican pharmaceutical market,

consumers paid, on average, $5,031 pesos for this medication.

• Currently, as a result of the equivalence agreements derived from the innovation policy, the price of thismedication in the Mexican market is $745 pesos (a price reduction of 85%).

Prices Comparison: Medicines for Diabetes• The Mexican Government has introduced five new medications to the Mexican pharmaceutical market as a

platform of global launching: two are used in the treatment of Type 2 Diabetes; one more is used in the treatmentof Chronic Obstructive Pulmonary Disease (COPD). Another medication is used in the treatment of pulmonaryhypertension and the last medicine is used, in combination with a medical device, in the treatment of prostatecancer.

• The drug Empagliflozine is currently sold in the United States at a price of $316 USD ($4,679 pesos). The price ofthis medicine in Mexico is $1,222 pesos, that is, 74% lower than in the United States.

$1,222

$4,679

$0.00

$1,000.00

$2,000.00

$3,000.00

$4,000.00

$5,000.00

México EUA

Peso

s

Prices Comparison: Medicines for Diabetes*

(in pesos)

Price of themedication is 74%

lower in Mexico

* Prices in México were obtained in Wal Mart supermarkets.Prices in the United States were obtained in Wal Mart supermarkets.

23

Removal of the requirements to have a manufacturing plant on national soil

In 2011 the Mexican Government removed the requisite to have a manufacturing plant in Mexico to market a medicine

Approval of the first 633 registrations in this category which had been requested more than 10months before.

Impact:

Investment above 100 million dollarsin the following five years have beenmade.

100% increase in the workforce of thefirms involved.

BENEFITS:

• Increase the supply of pharmaceuticals.• Availability of new molecules for research and

development.

Medical Devices

List of products that are Not Medical Devices

Stage 1: 1,669 products.

Stage 2: 2,242 products.

HighMediumLow

98“IA”

I II III

No Yes

Deregulation of Medical DevicesThe new scheme for the Medical Devices clasification was performed in two stages: 1. Stage 1: December, 2011 (1,669 products).2. Stage 2: January, 2015 (573 products).

Deregulation of Medical DevicesComparative Staged

Stage 1 Stage 2 TotalMD excluded fromregistration (units) 1,669 products 573 products 2,242 products

Reduced in the regulatoryload (%) 12.1% 4.1% 16.2%

Releasing of economicresources 4,021 million of pesos 1,414 million of pesos 5,435 million of pesos

Releasing of economicresources (% of GDP) 0.031% of GDP 0.007% of GDP 0.038% of GDP

Releasing of economicresources (% of MD market) 12.9% of MD market 4.5% of MD market 17.4% of MD market

• These actions allow a more efficient use of economic resources for the industry of medicaldevices.

Deregulation program of Medical Devices• The Medical Devices Desregulation program implemented by COFEPRIS, gives the

following results:

Issuance of Registrations through Equivalence Agreements

Received Applications 4,824

Market Value of the applications 417.5 million dollars in the Mexican market(2.09 million pesos each registration).

Reduction in the Regulatory Burden 40%

Approved Applications64% from FDA

33% from Health Canada3% from Japan

The Incoming Applications Correspond to:(Medical Devices)

33% Class 140% Class 227% Class 3

• The scheme is based upon the recognition of the registrations issued by FDA,Health Canada, and Japan for medical devices of any class and COFEPRIS willissue the corresponding registration in a maximum period of 30 working days.

• To this date 3,681 sanitary registrations have been approved by COFEPRIS.

27

Recognition of foreign Certificates for Good Manufacturing Practices

Considering the high impact of the on site visits on the process of approval and renewal ofsanitary registrations, Mexico published on June 22, 2011 guidelines to expedite andfacilitate the process:

1• The certificates of GMP´s issued by FDA (USA), ANVISA (Brazil), Health Canada,

Pharmaceutical and Food Safety Bureau (Japan), TGA (Australia) and EMA independentlyof the country where the manufacturing plant is located will be recognized by COFEPRIS.

2• The on site verification of GMPs from COFEPRIS will be issued in favor of the

manufacturing plant or the firm in question and not the firm doing the import.

3• Consequently, the recognized GMPs by COFEPRIS could be used by any economic agent

to obtain the sanitary registration or the corresponding extension.

28

ESTIMATED BENEFITS OF DEREGULATION1,339 GMP applications eliminated

Concept Million USD

Reduced Aggregated administrative burden 15.2Reduced Aggregated Opportunity Cost 1,850.4 Total Economic Benefits 1,865.6 0

Savings as percentage of domestic GDP 0.015%

• The economic benefits are composed in 99% of the opportunity cost of thetermination of the administrative process and represent about 200 milliondollars.

• Each day the termination of an administrative process is delayed it has a costbetween $50,000 and $60,000 pesos for the industry.

Recognition of Certificates of Good Manufacturing PracticesSavings derived from the measure

29

Intellectual Property Rights in Mexico• An international comparison shows that Mexico is a trailblazer regarding the protection of intellectual

property rights.• According to the Global Intellectual Property Center (GIPC) Index of the U.S. Chamber of

Commerce, Mexico is ranked the highest among Latin American countries.• This index measures three different types of intellectual property rights: patents, trademarks and

copyright. It indicates the gaps between advances in legislations and their enforcement.

Source: Global Intellectual Property Center (GIPC, 2014). U.S. Chamber of Commerce.

28.52

27.59

27.15

25.12

24.18

23.24

21.32

17.4

14.36

14.27

13.66

13.55

13.28

12.38

11.72

11.68

11.62 11.6

10.83

9.8 9.45

8.09

7.8 7.34

6.95

0

5

10

15

20

25

30

Inde

x

Global Intellectual Property Center (GIPC) Index(overall country scores, 2014)

30

International Harmonization

Production of Vaccines (Birmex, 1998-2012)

Year 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2014 2016 20180

20 -

60 -

100 -

80 -

40 -

113.9(MD)

92.4 (MD)

75.0 (MD) 72.1 (MD)

79 .0 (MD)

120 -

73.3 (MD)

48.5 (MD)

49.8 (MD)

100.0 (MoD)

45.4 (MD)

47.2 (MD) 50.7 (MD) 48.7 (MD)

(Milli

ons o

f dos

es M

D))

25.6 (MD)

35.8 (MD)

Agents for clinical tests

Biological

Serums

BacterialVaccines

Viral Vaccines

-65.8%

• In 2014, COFEPRIS was recognized by the World Health Organization (WHO) for vaccines andwas declared as a FUNCTIONAL agency for the period June 2014 - June 2017.

• As a result, Mexico entered to the elite group of 28 countries holding this recognition, equivalent toonly 14% of the world sanitary agencies.

100(MD)

WHO Vaccines

Recognition of COFEPRIS by the WHO for Vaccines

32

• In 2012, COFEPRIS became the fifth Latin American Agency to receive the PAHO Certification asregional reference body.

• As a result of this Certification, sanitary registrations issued by COFEPRIS are currentlyrecognized in 7 countries: Ecuador, El Salvador, Colombia, Chile, Costa Rica, Panama andBelice.

Recognition of sanitary registrations abroad

33

Sanitary Market Surveillance

In its fight against informality, the Ministry of Health proposed the following reforms tothe regulation of the Health Law regarding advertisement:

• To require sanitary registration and/or advertisement permission to announcers in order toadvertise products.

• To require the media to cease in 24 hours the advertisement for a product or service thatdoes not comply with the legal provisions.

• Increase in 400% the sanctions imposed for not complying with the provisions of theregulation.

The reform was published in the Official Gazette on January 19, 2012 and it wasenabled on March 2, 2012.

34

Regulation of advertisement versus «miracle» products

35

PROFECO agreementMarch 13, 2012.

Copy Advice´s starts

Orders suspension and refusal of advertising

Preparation and consensus reforms RLGSMPForfeiture to CV Directo and Innova

Publication

CANIPEC agreement

Entry into force

In 12 months, with the implementation of the comprehensive strategy by COFEPRIS, the advertisement ofunauthorized products was reduced in 100%, from 58 to 0 products with media appearances.

• On January 18, 2012 the Health Law was amended aiming to prevent and stop misleadingadvertisement of fake miracle cures.

Regulation on advertisement of «Miracle» Products

60 58

45

5247 49 47

4138 40

31 30

61 0 0 0 0 0 0 0 0 0 0 0 0 0 0

0

10

20

30

40

50

60

36

From January 2011 to March 2012, media appearances of such “miracle”cures was reduced about 87.4%. In november, 2015 there were no mediaappearances.

Advertisements per month(January 2011 - November 2015)

2,4682,222

2,012

2,571

2,9292,950

2,3072,133

1,9032,212

1,973

2,970

1,386

1750 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

0

500

1,000

1,500

2,000

2,500

3,000

3,500

Feb-

11Ma

r-11

Apr-1

1Ma

y-11

Jun-

11Ju

l-11

Aug-

11Se

p-11

Oct-1

1No

v-11

Dec-1

1Ja

n-12

Feb-

12Ma

r-12

Apr-1

2Ma

y-12

Jun-

12Ju

l-12

Aug-

12Se

p-12

Oct-1

2No

v-12

Dec-1

2Ja

n-13

Feb-

13Ma

r-13

Apr-1

3Ma

y-13

Jun-

13Ju

l-13

Aug-

13Se

p-13

Oct-1

3No

v-13

Dec-1

3Ja

n-14

Feb-

14Ma

r-14

Apr-1

4Ma

y-14

Jun-

14Ju

l-14

Aug-

14Se

p-14

Oct-1

4No

v-14

Dec-1

4Ja

n-15

Feb-

15Ma

r-15

Apr-1

5Ma

y-15

Jun-

15Ju

l-15

Aug-

15Se

p-15

Oct-1

5No

v-15

Sanitary surveillance:Inspections and forfeiture of products (2010-2016*)

Product 2010 2011-2016 Total Growth rate Average growthrate

Tobacco 40,000 cigarettes 301,419,072 cigarettes 301,459,072 cigarettes 515,581%

67,885%

Alcohol 87,175 litters 5,127,615 litters 5,215,331 litters 2,340%

Clenbuterol 0 suspended slaughterhouses

58 suspended slaughterhouses

58 suspended slaughterhouses -

«Miracle» products 40,000 units 3,944,772 units 3,984,772 units 6,268%

HealthSupplies* 2.5 tons.

381.57 tons. (medicines);9,005,785pieces (med.

devices)384 tons. (medicines) 14,513%

37

• The strategy of sanitary surveillance includes seizures of tobacco, alcohol, clenbuterol,«miracle» products and health supplies.

• From 2011 to Junly 2016, a total of 58 slaughterhouses have been suspended.• With this strategy COFEPRIS has increased its efficacy in 67,885% during 2011 – July

2016 compared with 2010, on average.

Source: COFEPRIS (2014). Includes data from 2010 to July, 2016. * On medicines comparison is between 2009 and the sum of inspections from 2010 to 2016.

38

Conclusions

• The Mexican pharmaceutical market, estimated at 195.1 billion pesos in 2014, ranked among the15 most important world markets and the second in Latin America.

• Between 2011 and 2014, the growth of the mexican pharmaceutical market was of 13.2%, while inthe period of 2008-2010, the rate reached only 1.8%.

Source: COFEPRIS, witth data from INEGI (2011) and CANIFARMA (2015).*Estimated value for 2014.

$0

$50,000

$100,000

$150,000

$200,000

2008 2009 2010 2011 2012 2013 2014

Millio

nsof

pes

os

Value of the Mexican pharmaceutical market, 2005-2014*(millions of pesos)

Growth Rate: 1.8%Growth Rate: 13.2%

• From 2008 to 2012 government spending in medicines increased by 64%.

Source: Author´s elaboration with data from SINAIS, SS.

0

10,000

20,000

30,000

40,000

50,000

60,000

2008 2009 2010 2011 2012

Millio

nsof

pes

os

Public Spending in Medicines(2008-2012)

Source: INEGI (2015).

• Mexico received 337.6 billion dollars in Foreign Direct Investment between 2000-2013, which represents a yearly average of 10.5%.

$0

$5,000

$10,000

$15,000

$20,000

$25,000

$30,000

$35,000

$40,000

$45,000

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

millio

nsof

dolla

rs

Foreign Direct Investment(2000-2013)

(millions of dollars)

• The issuance of 28,802 sanitary registrations from March 2011 to June 2016, represents a marketvalue greater than 2.4 billion dollars. Progress has been as follows:

• A total of 18,556 sanitary registrations have been issued from June 2012 to June 2016. Thisimprovement implies an average of 379 monthly registrations. The issuance of sanitary registrationswill continue growing given that COFEPRIS regulates 10% of GDP..

0

7

14

1922 23

2527 28 28 29

2010 2011 2012 2013 Jun-14 Dec-14 Jun-15 Dec-15 Apr-16 May-16 Jun-16

Sani

tary

regi

stra

tions

issu

ed(T

hous

ands

)

Issuance of more than 450 sanitary registrations per month, on average, in the period

March, 2011- June 2016

• The Ministry of Health has an important tool to impact the economy in a positive mannerthrough the application of sanitary regulation with measures that increase the efficiency ofoperation in the regulated sectors.

• Through the use of simplified processes of authorization and sanitary regulation, growthand economic benefits for more than 100 billion pesos in those regulated sectors havebeen created, specifically in pharmaceutical, pharmaceutical chemistry, food andagrochemical industries.

• There is a causal relationship between the efficiency and transparency of health policyand the economic growth in the regulated sectors.

• For the implementation of these actions is crucial a permanent coordination between theMinistry of Health / COFEPRIS and the Ministries of Finance, Economy, Foreign Affairs,Environment and Agriculture in order to generate comprehensive public policies.

COFEPRIS: Using regulation to better protectthe population’s health and

transform the market.

The Case of Mexico

September 2016

cofepris: using regulation to better protect the … · in the verification units; they also...

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