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COFEPRIS: Using regulation to better protect

the population’s health and


transform the market.

The Case of Mexico

September 2016
Regulated Sectors by COFEPRIS

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

Regulated Sectors Distribution


1. Food and beverages Marketing

2. Health supplies

3. Health services Production Imports


4. Emergences
5. Pesticides, Vegetable nutrients and
Toxic substances

6. Cosmetics and beauty products Retail and


Exports
Suply
7. Environmental Risks
8. Labor Safety and Health Advertising
The value of the products regulated by COFEPRIS represents 9.8% of
Mexican GDP.
Industries Regulated by COFEPRIS
(2009 last available year)

700
624
Billions

600

500

400

300 237

200 151 139

100
24 10
-
Industria Alimentaria Industria Tabaco y Industria Farmacéutica Industria química Fabricación de Fabricación Material
Bebidas Fertilizantes, pesticidas Desechable de uso
y otro agroquímicos médico, dental,
oftálmico 3
COFEPRIS regulates 44 cents out of every peso spent by households in Mexico
through 3 categories: Food, beverages; health care; and personal care products.
Household Expenditures per Category
(as a % of total household expenditures)*

34.0%
Food, beverages and tobacco
Health care products

56.2% Personal care products


Others

2.5%

7.3%
Source: Encuesta Nacional de Ingresos y Gastos de los Hogares (ENIGH, 2012). INEGI (2013).
* Only current monetary expenditures are considered.
COFEPRIS regulates about 11% of the total trade flow between Mexico and the rest of the
world (64% of GDP).

3.5 25,214 mdd

2.5
% of total trade flow

15,037 mdd
2

10,551 mdd
1.5

1 6,747 mdd 6,422 mdd


5,394 mdd 5,142 mdd 4,732 mdd
0.5 2,200 mdd
1,421 mdd
439 mdd
0
Instrumentos y Otros Productos Productos Aceites Productos de Carne y Bebidas y Leche, Pescados, Tabaco y
aparatos de Productos químicos farmacéuticos escenciales, las industrias despojos vinagre lácteos, crustáceos y sucedáneos
óptica y Alimentarios y orgánicos e Jabon, Ceras, químicas comestibles huevos y miel moluscos elaborados
médicos Derivados de inorgánicos Lubricantes
Materias
Primas

Source: DEOI with data from Banco de Mexico (2014). 5


Pharmaceutical Policy

6
Characteristics of pharmaceutical policy
– Rests on four fundamental pillars
– The pillars are aligned with the 3 priorities of health policy established by the Federal
Government.
– Its main objective is to improve access of the population to a well-supplied drug market that
offers innovative and generic medicines at the best prices.

Pillars of Pharmaceutical Policy Government’s Health Policy Priorities


A regulatory agency that guarantees the
safety, quality and eficacy of all drugs.
A reliable scheme to authorize sanitary
1. Effective Access
registrations.
2. Service Quality
Removal of barriers to market entry for
products that are safe and of high quality.
3. Prevention
Harmonization of the sanitary agency with best
international practices.
Evolution of the Mexican Pharmaceutical Regulation
During this period the market 1. The legal requirement of Domestic market with
authorizations for medicines had bioequivalence is only two types of
indefinite duration and without the legal implemented. medicines:
obligation to be bioequivalent. 2. A netwrork of laboratories 1. Innovative Drugs
is created to perform 2. Generics
bioequivalence tests
through Authorized Third
Parties.

1920 2001 2005 2009 2010 2011 2012 2014

Enactment of Implementatio PAHO


First Saniitary July 5 Reform to the recognizes WHO
the n of National
Registration issued COFEPRIS is National Health SecondaryCOFEPRIS as declares
Biotechnological Healh Law
in Mexico created Law Regulation NRA of COFEPRIS
Medicines Act. Reform on
renewal of s for Regional a Functional
Sanitary Biotechnol Reference NRA
Registrations ogy
Medicines
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 an
existent Registration to Cofepris.
• The “Pre-dictamination” certificate of Third Parties allow to reduce signifcantly the processing
time of each individual filing. For example, in the case of new registrations the processing time was
reduced by an average of approximately 2 years.
Average processing time for filings of drug products (months)

Trámite COFEPRIS 30
Registro

Trámite con Pre-dictamen 4.5


Type of filing

Trámite COFEPRIS 6
Prórroga

Trámite con Pre-dictamen 3.75

Trámite COFEPRIS 2
Modificación

Trámite con Pre-dictamen 0.5

0 5 10 15 20 25 30
Months
9
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 composition
between approved and in process.
Filings submitted with Pre-dictamination of
Authorized Third Parties
Number of
Procedure In process Approved
Filings
New Registration 3,342 410 2,931
Medical Devices Extensions 772 36 736
Modification 2,189 182 2,007
New Registration 715 95 592
Medicines Extensions 495 58 425
Modification 2,046 254 1,765
Total 9,559 1,035 8,456
The approval of those registers have been achieved with a team of 105 evaluators in the verification units; they also
contribute to the activities performed by the 141 evaluators from COFEPRIS, in order to increase the productivity in 10
the issuing of registers.
Generics Policy

• The Mexican Government has released 37 active substances. This corresponds to


491 new registrations of generic medications, which address 71% of Mexico´s
mortality causes.

• The Generics Policy of the Mexican Government has allowed an average reduction
of 61% in medicines prices, which represents average savings of $1,047 pesos for the
consumer.
Accumulated Mortality causes
Number of Released New Generics Additional
Savings (billions of attended, as a %
Packages Substances Options Patients
dollars) of total of deaths

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

• There is no international record of a generics releasing strategy of such magnitud and in


a reduced period of time.
11
• 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.

Causes of Mortality in Mexico


(% of total of deaths)

Atorvastatine
Valsartan
18.1 Clopidogrel
Cardiovascular
29.0 Losartan Endocrinology
Irbersartan
Telmisartan Oncology

14.1 Pulmonary
Pioglitazone
Lamivudine Neurology
Imiquimod
Abacavir
Docetaxel Infectious and transmittable
Meropenem 12.2 Gemcitabine
Valganciclovir 12.2 Bicalutamide Other generic medicines
5.3 Anastrozol
7.0 Pemetrexed
Other diseases
Escitalopram 2.1
Montelukast Zoledronic Acid
Donepezil
Cefepime Topotecán
Quetiapine
Mometasone Bortezomib
Olanzapine
Linezolid*
Source: INEGI (2014).
* Linezolid is a wide spectrum antibiotic used mainly in pulmonary diseases.
Private Market
The average reduction in prices of generics has been 61%, which represents an average saving of $1,047 pesos for
the consumer.
6000
Precio de Innovador
Average (Promedio)
price of innovator Precio de Genérico
Average (Promedio)
price of generics
Average
reduction in
5000 prices:
$1,052
(Reduction of
Reduction 62%)
of 82%
4000 in price

Reduction Reduction
of 88% of 61%
Pesos

in price
3000 in price
Reduction Reduction Reduction Reduction Reduction
of 83% of 81% of 79% of 72% of 68%
in price in price in price in price in price
2000 Reduction
of 89% Reduction Reduction Reduction Reduction Reduction Reduction
in price of 86% of 81% of 80% of 73% of 70% of 59%
in price in price in price in price in price in price
1000

Source: COFEPRIS (2015). 13


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

Average
Precio price of innovator
de Innovador (Promedio) Average
Precio price of generics
de Genérico (Promedio) Average
18000 reduction in
prices:
16000 Reduction
$1,052
of 29%
in price (Reduction of
14000

12000
Pesos

10000
Reduction Reduction Reduction Reduction
8000 of 54% of 53% of 42%
of 46%
in price in price in price in price
Reduction Reduction Reduction Reduction Reduction Reduction Reduction Reduction Reduction
6000 of 59% of 53% of 49% of 39% of 27% of 27%
of 55% of 53% of 46%
in price in price in price in price in price in price in price in price in price
4000

2000

Source: COFEPRIS (2015).


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

Precio Promedio en Licitaciones


Average IMSS Públicas
public auction price indel IMSS 2011
2011
PrecioAverage
Promedio en public
IMSS Licitaciones
auction Públicas del IMSS 2012
price in 2012-2015
$6,000 Reduction
Average of 11%
reduction in in price
$5,000
prices: $440
(Reduction of
$4,000 60%)
Reduction
Pesos

of 82%
$3,000 in price

Reduction Reduction
Reduction Reduction of 24%
Reduction of 90%
$2,000 of 76% of 46% Reduction in price Reduction
Reduction Reduction of 91% in price in price Reduction in price of 43% of 19%
of 94% of 91% in price
of 48% in price in price
in price in price
$1,000 in price

$0

15
Source: IMSS (2012, 2013) and COFEPRIS (2015).
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 Mexico
than in Central America.
Price Comparison in the Generics Market
in Mexico and Central America (2014)*
México (current $US) Promedio Centroamérica
Average Central America (current $US)
$350
$307.60
Prices in current US dollars

$300
$250
$200
$150
$100 $87.00

$50 $31.40
$9.00 $5.32 $15.67
$0
Oncology
Oncología Cardiovascular Diabetes

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 American
countries.
Price Comparison in the Generics Market
in Mexico and South America (2014)*
MEXICO CURRENT US AVERAGE SOUTH AMERICA CURRENT US

120 110.29
Prices in Current US Dollars

100 87
80

60

40 30.71
19.81
20 9 5.32
0
ONCOLOGY CARDIOVASCULAR DIABETES
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).
Innovation policy
Agreement for the promotion of innovation
• The Mexican Government established an innovation policy relying on regulatory cooperation among
different 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 the
European Union.
2. To encourage clinical research, Mexico substituted the requirement of a foreign free sale certificate with
a report of clinical studies in Mexican population.
Days to Grant Registration for Innovative Drugs
400 360
300 290
300 270
Number of Days

220 203
200 180 180
150
120 120
90
100 60

0
México (antes)

Argentina
Canadá

España

China

Reino Unido

Brasil
Singapur

India
Arabia Saudita

Estados Unidos
Australia

México (con
acuerdos)
Agreement for the
Promotion of Innovation
• The opportunity cost associated with the days a file is processed has
decreased in approximately 40 million dollars (500 million pesos). This cost was
estimated in 45 million dollars (570 million pesos).*
• Further, with the equivalence agreement on new molecules, the regulatory
burden for each file decreases in 82%.
Benefits of the agreement on new molecules
Before the agreement With the agreement
45 million dollars

Decrease in opportunity cost of 40


million dollars (500 million pesos). Reduction in regulatory burden
of 82%.

7 million dollars 100%

18%

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


* Calculation of the opportunity cost consists of the daily administrative cost to process registrations for new molecules multiplied by the
19
number of days requeried to grant authorization.
Innovation Policy
• As a result of the innovation policy, from 2012 to 2016, COFEPRIS issued 213 new marketing
authorizations for innovative medicines, treating 21 different therapeutical classes
representing 73% of mortality causes in Mexico.
• This represents an increase of 7,000% in the supply of medicines with respect to the 3 registrations
issued in 2010. Registros emitidos a medicamentos innovadores
• . (2010-2016)
213
From 2012 to 2016, 213 sanitary
registrations were issued. This represents
an increase of 7,000%, compared to 2010

2010 2012-2015
2012-2016
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 this
medication in the Mexican market is $745 pesos (a price reduction of 85%).

Prices Comparison:
Neumological Medicines*
(in pesos)
$8,000 $6,996
$7,000 $5,780
$6,000
$5,000
Pesos

$4,000
$3,000 $2,316
$2,000 $745
$1,000
$0
Región Centro Región Sureste Región Frontera México
Before entry to the Mexican After entry to the Mexican
pharmaceutical market pharmaceutical 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: 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 treatment
of Chronic Obstructive Pulmonary Disease (COPD). Another medication is used in the treatment of pulmonary
hypertension and the last medicine is used, in combination with a medical device, in the treatment of prostate
cancer.
• The drug Empagliflozine is currently sold in the United States at a price of $316 USD ($4,679 pesos). The price of
this medicine in Mexico is $1,222 pesos, that is, 74% lower than in the United States.

Prices Comparison:
Medicines for Diabetes*
(in pesos)
$5,000.00 $4,679
Price of the
$4,000.00 medication is 74%
$3,000.00 lower in Mexico
Pesos

$2,000.00
$1,222
$1,000.00

$0.00
México EUA
* Prices in México were obtained in Wal Mart supermarkets.
Prices in the United States were obtained in Wal Mart supermarkets.
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 10
months before.

Impact:
BENEFITS:
Investment above 100 million dollars
in the following five years have been
• Increase the supply of pharmaceuticals. made.
• Availability of new molecules for research and
development. 100% increase in the workforce of the
firms involved.

23
Deregulation of Medical Devices
The 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).

Medical Devices

No Yes

Low Medium High


List of products that are
Not Medical Devices
I II III
Stage 1: 1,669 products. 98
“IA”
Stage 2: 2,242 products.
Deregulation program of Medical Devices
• The Medical Devices Desregulation program implemented by COFEPRIS, gives the
following results:
Deregulation of Medical Devices
Comparative Staged
Stage 1 Stage 2 Total
MD excluded from
1,669 products 573 products 2,242 products
registration (units)
Reduced in the regulatory
12.1% 4.1% 16.2%
load (%)
Releasing of economic
4,021 million of pesos 1,414 million of pesos 5,435 million of pesos
resources
Releasing of economic
0.031% of GDP 0.007% of GDP 0.038% of GDP
resources (% of GDP)
Releasing of economic
12.9% of MD market 4.5% of MD market 17.4% of MD market
resources (% of MD market)

• These actions allow a more efficient use of economic resources for the industry of medical
devices.
Issuance of Registrations through Equivalence Agreements
• 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 will
issue the corresponding registration in a maximum period of 30 working days.
Received Applications 4,824

417.5 million dollars in the Mexican market


Market Value of the applications
(2.09 million pesos each registration).

Reduction in the Regulatory Burden 40%

64% from FDA


Approved Applications 33% from Health Canada
3% from Japan
33% Class 1
The Incoming Applications Correspond to:
40% Class 2
(Medical Devices)
27% Class 3

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


Recognition of foreign Certificates for Good Manufacturing Practices
Considering the high impact of the on site visits on the process of approval and renewal of
sanitary registrations, Mexico published on June 22, 2011 guidelines to expedite and
facilitate the process:

• The certificates of GMP´s issued by FDA (USA), ANVISA (Brazil), Health Canada,
Pharmaceutical and Food Safety Bureau (Japan), TGA (Australia) and EMA independently
1 of the country where the manufacturing plant is located will be recognized by COFEPRIS.

• 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.
2

• Consequently, the recognized GMPs by COFEPRIS could be used by any economic agent
to obtain the sanitary registration or the corresponding extension.
3
27
Recognition of Certificates of Good Manufacturing Practices
Savings derived from the measure

• The economic benefits are composed in 99% of the opportunity cost of the
termination of the administrative process and represent about 200 million
dollars.
• Each day the termination of an administrative process is delayed it has a cost
between $50,000 and $60,000 pesos for the industry.
ESTIMATED BENEFITS OF DEREGULATION
1,339 GMP applications eliminated
Concept Million USD
Reduced Aggregated administrative burden 15.2
Reduced Aggregated Opportunity Cost 1,850.4
Total Economic Benefits 1,865.6 0

Savings as percentage of domestic GDP 0.015%


28
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.
Global Intellectual Property Center (GIPC) Index
30 (overall country scores, 2014)
25

20
Index

15
28.52

27.59

27.15

25.12

24.18

23.24

21.32

10
17.4

14.27

13.66

13.55
14.36

13.28

12.38

11.72

11.68

10.83
11.62

11.6

9.45
5

9.8

8.09

7.34

6.95
7.8
0

Source: Global Intellectual Property Center (GIPC, 2014). U.S. Chamber of Commerce. 29
International Harmonization

30
Recognition of COFEPRIS by the WHO for Vaccines
• In 2014, COFEPRIS was recognized by the World Health Organization (WHO) for vaccines and
was 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 to
only 14% of the world sanitary agencies.

Production of Vaccines (Birmex, 1998-2012)


120 -
113.9
(MD)
Agents for 100.0 100
100 - clinical
(MoD) (MD)
tests 92.4 (MD)
WHO Vaccines
(Millions of doses MD))

80 - 79 .0 (MD)
75.0 (MD) 73.3
Biological 72.1 (MD) (MD)
-65.8%
60 - 49.8 50.7
48.5 (MD) 45.4 47.2 (MD)
Serums (MD) 48.7 (MD)
(MD) (MD)
40 - 35.8
(MD)
Bacterial 25.6
Vaccines (MD)
20 -

Viral
Vaccines
0
Year 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2014 2016 2018
Recognition of sanitary registrations abroad
• In 2012, COFEPRIS became the fifth Latin American Agency to receive the PAHO Certification as
regional reference body.
• As a result of this Certification, sanitary registrations issued by COFEPRIS are currently
recognized in 7 countries: Ecuador, El Salvador, Colombia, Chile, Costa Rica, Panama and
Belice.

32
Sanitary Market Surveillance

33
Regulation of advertisement versus «miracle» products

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

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


advertise products.
• To require the media to cease in 24 hours the advertisement for a product or service that
does not comply with the legal provisions.
• Increase in 400% the sanctions imposed for not complying with the provisions of the
regulation.

The reform was published in the Official Gazette on January 19, 2012 and it was
enabled on March 2, 2012.
34
Regulation on advertisement of «Miracle» Products
• On January 18, 2012 the Health Law was amended aiming to prevent and stop misleading
advertisement of fake miracle cures.

60
58
60
52
49 CANIPEC agreement
50 47 47
45 PROFECO agreement
41 40 March 13, 2012.
38
40
Copy Advice´s starts 31
30
30

Orders suspension and refusal of advertising Publication


20 Entry into force

10 Preparation and consensus reforms RLGSMP 6


1 Forfeiture
0 0to CV
0 Directo
0 and0 Innova
0 0 0 0 0 0 0 0 0
0

In 12 months, with the implementation of the comprehensive strategy by COFEPRIS, the advertisement of
unauthorized products was reduced in 100%, from 58 to 0 products with media appearances. 35
From January 2011 to March 2012, media appearances of such “miracle”
cures was reduced about 87.4%. In november, 2015 there were no media
appearances.
Advertisements per month
(January 2011 - November 2015)
3,500

2,950
2,929 2,970
3,000
2,571
2,468
2,500 2,307
2,222 2,1332,212
2,012
2,000 1,9031,973

1,500 1,386

1,000

500
175
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
0
Aug-11
Sep-11

Aug-12
Sep-12

Aug-13
Sep-13

Aug-14
Sep-14

Aug-15
Sep-15
Apr-11

Apr-12

Apr-13

Apr-14

Apr-15
May-11

May-13

May-14

May-15
Jul-11

Oct-11

May-12
Jul-12

Oct-12

Jul-13

Oct-13

Jul-14

Oct-14

Jul-15

Oct-15
Jun-11

Jan-12

Jun-12

Jan-13

Jun-13

Jan-14

Jun-14

Jan-15

Jun-15
Mar-11

Mar-12

Mar-13

Mar-14

Mar-15
Feb-11

Feb-12

Feb-13

Feb-14

Feb-15
Nov-11
Dec-11

Nov-12
Dec-12

Nov-13
Dec-13

Nov-14
Dec-14

Nov-15
36
• 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.
Sanitary surveillance:
Inspections and forfeiture of products (2010-2016*)
Average growth
Product 2010 2011-2016 Total Growth rate
rate

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

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


5,215,331 litters
0 suspended 58 suspended 58 suspended
Clenbuterol -
slaughterhouses slaughterhouses slaughterhouses 67,885%
«Miracle»
40,000 units 3,944,772 units 3,984,772 units 6,268%
products
381.57 tons. (medicines);
Health
2.5 tons. 9,005,785pieces (med. 384 tons. (medicines) 14,513%
Supplies*
devices)
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. 37
Conclusions

38
• The Mexican pharmaceutical market, estimated at 195.1 billion pesos in 2014, ranked among the
15 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 in
the period of 2008-2010, the rate reached only 1.8%.

Value of the Mexican pharmaceutical market, 2005-2014*


(millions of pesos)
Growth Rate: 13.2%
Growth Rate: 1.8%
$200,000

$150,000
Millions of pesos

$100,000

$50,000

$0
2008 2009 2010 2011 2012 2013 2014
Source: COFEPRIS, witth data from INEGI (2011) and CANIFARMA (2015).
*Estimated value for 2014.
• From 2008 to 2012 government spending in medicines increased by 64%.

Public Spending in Medicines


(2008-2012)
60,000

50,000

40,000
Millions of pesos

30,000

20,000

10,000

0
2008 2009 2010 2011 2012
Source: Author´s elaboration with data from SINAIS, SS.
• Mexico received 337.6 billion dollars in Foreign Direct Investment between 2000-
2013, which represents a yearly average of 10.5%.

Foreign Direct Investment


(2000-2013)
(millions of dollars)
$45,000

$40,000

$35,000

$30,000
millions of dollars

$25,000

$20,000

$15,000

$10,000

$5,000

$0
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
Source: INEGI (2015).
• The issuance of 28,802 sanitary registrations from March 2011 to June 2016, represents a market
value greater than 2.4 billion dollars. Progress has been as follows:
Issuance of more than 450 sanitary registrations per
month, on average, in the period
March, 2011- June 2016

28 28 29
27
25
23
Sanitary registrations issued

22
19
(Thousands)

14

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

• A total of 18,556 sanitary registrations have been issued from June 2012 to June 2016. This
improvement implies an average of 379 monthly registrations. The issuance of sanitary registrations
will continue growing given that COFEPRIS regulates 10% of GDP..
• The Ministry of Health has an important tool to impact the economy in a positive manner
through the application of sanitary regulation with measures that increase the efficiency of
operation in the regulated sectors.

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

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

• For the implementation of these actions is crucial a permanent coordination between the
Ministry 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 protect
the population’s health and
transform the market.

The Case of Mexico

September 2016