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
7. Environmental Risks
8. Labor Safety and Health
Retail and
Suply
Exports
Advertising
The value of the products regulated by COFEPRIS represents 9.8% of
Mexican GDP.
Industries Regulated by COFEPRIS
Billions
(2009 last available year)
700
624
600
500
400
237
300
151
200
139
100
-
24
Industria Alimentaria
Industria Tabaco y
Bebidas
Industria Farmacéutica
Industria química
Fabricación de
Fertilizantes, pesticidas
y otro agroquímicos
10
Fabricación Material
Desechable de uso
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
Personal care products
56.2%
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
3
% of total trade flow
2.5
2
15,037 mdd
10,551 mdd
1.5
6,747 mdd
1
6,422 mdd
5,394 mdd
5,142 mdd
4,732 mdd
0.5
0
2,200 mdd
Instrumentos y
Otros
aparatos de
Productos
óptica y
Alimentarios y
médicos
Derivados de
Materias
Primas
Productos
químicos
orgánicos e
inorgánicos
Source: DEOI with data from Banco de Mexico (2014).
Productos
farmacéuticos
Aceites
escenciales,
Jabon, Ceras,
Lubricantes
Productos de
las industrias
químicas
Carne y
despojos
comestibles
Bebidas y
vinagre
Leche,
lácteos,
huevos y miel
1,421 mdd
Pescados,
crustáceos y
moluscos
439 mdd
Tabaco y
sucedáneos
elaborados
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
registrations.
Removal of barriers to market entry for
products that are safe and of high quality.
Harmonization of the sanitary agency with best
international practices.
1. Effective Access
2. Service Quality
3. Prevention
Evolution of the Mexican Pharmaceutical Regulation
During this period the market 1. The legal requirement of
bioequivalence is
authorizations for medicines had
implemented.
indefinite duration and without the legal
2. A netwrork of laboratories
obligation to be bioequivalent.
is created to perform
bioequivalence tests
through Authorized Third
Parties.
1920
First Saniitary
Registration issued
in Mexico
2001
July 5
COFEPRIS is
created
2005
2009
Enactment of
Reform to the
the
National Health
Biotechnological
Law
Medicines Act.
Domestic market with
only two types of
medicines:
1. Innovative Drugs
2. Generics
2010
Implementatio
n of National
Healh Law
Reform on
renewal of
Sanitary
Registrations
2011
2012
2014
PAHO
WHO
recognizes
SecondaryCOFEPRIS as declares
COFEPRIS
Regulation NRA of
a Functional
Regional
s for
NRA
Biotechnol Reference
ogy
Medicines
Benefits of Authorized Third Parties
Prórroga
Registro
Average processing time for filings of drug products (months)
Modificación
•
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.
Type of filing
•
Trámite COFEPRIS
30
Trámite con Pre-dictamen
4.5
Trámite COFEPRIS
6
Trámite con Pre-dictamen
3.75
Trámite COFEPRIS
2
Trámite con Pre-dictamen
0.5
0
5
10
15
Months
20
25
30
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
Procedure
Number of
Filings
In process
Approved
New Registration
3,342
410
2,931
Extensions
772
36
736
Modification
2,189
182
2,007
New Registration
715
95
592
Extensions
495
58
425
Modification
2,046
254
1,765
9,559
1,035
8,456
Medical Devices
Medicines
Total
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.
Number of
Packages
Released
Substances
New Generics
Options
Accumulated
Savings (billions of
dollars)
Mortality causes
attended, as a %
of total of deaths
Additional
Patients
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
Clopidogrel
Losartan
Irbersartan
Telmisartan
18.1
29.0
14.1
Lamivudine
Abacavir
Meropenem
Valganciclovir
Escitalopram
Donepezil
Quetiapine
Olanzapine
12.2
2.1
12.2
5.3
7.0
Source: INEGI (2014).
* Linezolid is a wide spectrum antibiotic used mainly in pulmonary diseases.
Montelukast
Cefepime
Mometasone
Linezolid*
Pioglitazone
Imiquimod
Docetaxel
Gemcitabine
Bicalutamide
Anastrozol
Pemetrexed
Zoledronic Acid
Topotecán
Bortezomib
Cardiovascular
Endocrinology
Oncology
Pulmonary
Neurology
Infectious and transmittable
Other generic medicines
Other 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
(Promedio)
Average
price of innovator
Precio
de Genérico
(Promedio)
Average
price of generics
Average
reduction in
prices:
$1,052
(Reduction of
62%)
5000
Reduction
of 82%
in price
Pesos
4000
3000
2000
Reduction
of 61%
in price
Reduction
of 88%
in price
Reduction
of 89%
in price
Reduction
of 86%
in price
Reduction
of 79%
in price
Reduction
of 81%
in price
Reduction
of 83%
in price
Reduction
of 81%
in price
Reduction
of 80%
in price
Reduction
of 68%
in price
Reduction
of 72%
in price
Reduction
of 73%
in price
Reduction
of 70%
in price
Reduction
of 59%
in price
1000
0
Source: COFEPRIS (2015).
13
• For example, treatments for cardiovascular diseases have decreased 89%, for oncological
diseases, 88%, and for diabetes mellitus, 86%.
Average
price of innovator
Precio
de Innovador
(Promedio)
18000
Average
price of generics
Precio
de Genérico
(Promedio)
Reduction
of 29%
in price
16000
14000
Average
reduction in
prices:
$1,052
(Reduction of
Pesos
12000
10000
8000
6000
4000
Reduction
of 59%
in price
Reduction
of 55%
in price
2000
0
Source: COFEPRIS (2015).
Reduction
of 54%
in price
Reduction
of 53%
in price
Reduction
of 53%
in price
Reduction
of 53%
in price
Reduction
of 49%
in price
Reduction
of 46%
in price
Reduction
of 46%
in price
Reduction
of 42%
in price
Reduction
of 39%
in price
Reduction
of 27%
in price
Reduction
of 27%
in price
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
Públicas
IMSS 2011
Average IMSS
public auction
price indel
2011
$6,000
Pesos
$5,000
$4,000
PrecioAverage
Promedio
en public
Licitaciones
del IMSS 2012
IMSS
auction Públicas
price in 2012-2015
Reduction
of 11%
in price
Average
reduction in
prices: $440
(Reduction of
60%)
Reduction
of 82%
in price
$3,000
$2,000
$1,000
Reduction
of 94%
in price
Reduction
of 91%
in price
Reduction
of 91%
in price
Reduction
of 90%
in price
Reduction
of 76%
in price
Reduction
of 48%
in price
Reduction
of 46%
in price
Reduction
of 43%
in price
Reduction
of 24%
in price
Reduction
of 19%
in price
$0
Source: IMSS (2012, 2013) and COFEPRIS (2015).
15
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)
Prices in current US dollars
$350
Average Central
America (current $US)
Promedio
Centroamérica
$307.60
$300
$250
$200
$150
$100
$87.00
$50
$0
$9.00
Oncology
Oncología
$31.40
Cardiovascular
$5.32
$15.67
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
Prices in Current US Dollars
120
100
AVERAGE SOUTH AMERICA CURRENT US
110.29
87
80
60
40
20
0
9
ONCOLOGY
30.71
19.81
CARDIOVASCULAR
5.32
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
360
270
220
200
203
180
180
150
120
120
India
Argentina
Reino Unido
Estados Unidos
China
Australia
España
Singapur
Arabia Saudita
0
Canadá
100
90
60
México (con
acuerdos)
290
Brasil
300
300
México (antes)
Number of Days
400
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
45 million dollars
Before the agreement
With the agreement
Decrease in opportunity cost of 40
million dollars (500 million pesos).
7 million dollars
Reduction in regulatory burden
of 82%.
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
number of days requeried to grant authorization.
19
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
3
2010
2012-2016
2012-2015
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%).
Pesos
Prices Comparison:
Neumological Medicines*
$8,000
$7,000
$6,000
$5,000
$4,000
$3,000
$2,000
$1,000
$0
$6,996
(in pesos)
$5,780
$2,316
$745
Región Centro
Región Sureste
Before entry to the Mexican
pharmaceutical market
Región Frontera
México
After entry to the Mexican
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
Pesos
$4,000.00
$3,000.00
$2,000.00
$4,679
Price of the
medication is 74%
lower in Mexico
$1,222
$1,000.00
$0.00
México
* Prices in México were obtained in Wal Mart supermarkets.
Prices in the United States were obtained in Wal Mart supermarkets.
EUA
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.
BENEFITS:
• Increase the supply of pharmaceuticals.
• Availability of new molecules for research and
development.
Impact:
Investment above 100 million dollars
in the following five years have been
made.
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
List of products that are
Not Medical Devices
Stage 1: 1,669 products.
Stage 2: 2,242 products.
98
“IA”
I
Medium
High
II
III
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
1,669 products
573 products
2,242 products
12.1%
4.1%
16.2%
Releasing of economic
resources
4,021 million of pesos
1,414 million of pesos
5,435 million of pesos
Releasing of economic
resources (% of GDP)
0.031% of GDP
0.007% of GDP
0.038% of GDP
12.9% of MD market
4.5% of MD market
17.4% of MD market
MD excluded from
registration (units)
Reduced in the regulatory
load (%)
Releasing of economic
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
Market Value of the applications
Reduction in the Regulatory Burden
Approved Applications
The Incoming Applications Correspond to:
(Medical Devices)
4,824
417.5 million dollars in the Mexican market
(2.09 million pesos each registration).
40%
64% from FDA
33% from Health Canada
3% from Japan
33% Class 1
40% Class 2
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:
1
2
3
• The certificates of GMP´s issued by FDA (USA), ANVISA (Brazil), Health Canada,
Pharmaceutical and Food Safety Bureau (Japan), TGA (Australia) and EMA independently
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.
• Consequently, the recognized GMPs by COFEPRIS could be used by any economic agent
to obtain the sanitary registration or the corresponding extension.
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
Reduced Aggregated administrative burden
Reduced Aggregated Opportunity Cost
Total Economic Benefits
Savings as percentage of domestic GDP
Million USD
15.2
1,850.4
1,865.6 0
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
(overall country scores, 2014)
30
25
6.95
7.34
7.8
8.09
9.45
9.8
10.83
11.6
11.62
11.68
11.72
12.38
13.28
13.55
13.66
14.27
17.4
23.24
24.18
27.15
21.32
14.36
5
25.12
10
27.59
15
28.52
Index
20
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 -
(Millions of doses MD))
100 80 -
113.9
(MD)
Agents for
clinical
tests
100
(MD)
100.0
(MoD)
92.4 (MD)
WHO Vaccines
75.0 (MD)
Biological
79 .0 (MD)
72.1 (MD)
73.3
(MD)
60 -
48.5
(MD)
Serums
-65.8%
49.8
(MD)
45.4
(MD)
47.2 (MD)
50.7
(MD)
48.7 (MD)
40 -
20 -
0
Bacterial
Vaccines
25.6
(MD)
35.8
(MD)
Viral
Vaccines
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
60
58
52
50
40
45
47
49
CANIPEC agreement
47
41
38
40
Copy Advice´s starts 31
30
20
10
0
PROFECO agreement
March 13, 2012.
30
Orders suspension and refusal of advertising
Preparation and consensus reforms RLGSMP
Publication
Entry into force
6
1 Forfeiture
0
0to CV
0 Directo
0 and
0 Innova
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.
0
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
3,000
2,950
2,929
2,970
2,571
2,468
2,307
2,222
2,1332,212
2,012
1,9031,973
2,000
2,500
1,500
1,386
1,000
0
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
Feb-11
Mar-11
Apr-11
May-11
Jun-11
Jul-11
Aug-11
Sep-11
Oct-11
Nov-11
Dec-11
Jan-12
Feb-12
Mar-12
Apr-12
May-12
Jun-12
Jul-12
Aug-12
Sep-12
Oct-12
Nov-12
Dec-12
Jan-13
Feb-13
Mar-13
Apr-13
May-13
Jun-13
Jul-13
Aug-13
Sep-13
Oct-13
Nov-13
Dec-13
Jan-14
Feb-14
Mar-14
Apr-14
May-14
Jun-14
Jul-14
Aug-14
Sep-14
Oct-14
Nov-14
Dec-14
Jan-15
Feb-15
Mar-15
Apr-15
May-15
Jun-15
Jul-15
Aug-15
Sep-15
Oct-15
Nov-15
500
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*)
Product
2010
2011-2016
Total
Growth rate
Tobacco
40,000 cigarettes
301,419,072 cigarettes
301,459,072 cigarettes
515,581%
Alcohol
87,175 litters
5,127,615 litters
Clenbuterol
0 suspended
slaughterhouses
58 suspended
slaughterhouses
5,215,331 litters
58 suspended
slaughterhouses
40,000 units
3,944,772 units
3,984,772 units
6,268%
2.5 tons.
381.57 tons. (medicines);
9,005,785pieces (med.
devices)
384 tons. (medicines)
14,513%
«Miracle»
products
Health
Supplies*
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.
Average growth
rate
2,340%
-
67,885%
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: 1.8%
$200,000
Millions of pesos
Growth Rate: 13.2%
$150,000
$100,000
$50,000
$0
2008
2009
Source: COFEPRIS, witth data from INEGI (2011) and CANIFARMA (2015).
*Estimated value for 2014.
2010
2011
2012
2013
2014
• From 2008 to 2012 government spending in medicines increased by 64%.
Public Spending in Medicines
(2008-2012)
60,000
Millions of pesos
50,000
40,000
30,000
20,000
10,000
0
2008
2009
Source: Author´s elaboration with data from SINAIS, SS.
2010
2011
2012
• Mexico received 337.6 billion dollars in Foreign Direct Investment between 20002013, which represents a yearly average of 10.5%.
Foreign Direct Investment
(2000-2013)
(millions of dollars)
$45,000
$40,000
millions of dollars
$35,000
$30,000
$25,000
$20,000
$15,000
$10,000
$5,000
$0
2000
Source: INEGI (2015).
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
• 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:
Sanitary registrations issued
(Thousands)
Issuance of more than 450 sanitary registrations per
month, on average, in the period
March, 2011- June 2016
19
22
23
25
27
28
28
29
Apr-16
May-16
Jun-16
14
7
0
2010
2011
2012
2013
Jun-14
Dec-14
Jun-15
Dec-15
• 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