political , environmental , social, technological, legal and economical analysis of pharmaceutical industry in Italy

1. PESTLE ANAYLSIS ON PHARMACEUTICAL INDUSTRY IN ITALY

2.  Italy is a country in Europe
 Rome is capital city of Italy
 Area is 301,225 square kms
 Population is approx. 61 million
Italian is the official language
Currency of Italy is Euro since 2002
June 2 – Republic day, celebrating the
constitution in 1946.
Roman Catholicism is the predominant
religion of Italy

3. POLITICAL

4. • Unitary Parliamentary Republic since 2 June 1946
• President is head of state and Prime Minister is head of
government
Sergio Matarella Matteo Renzi Beatrice Lorenzine

5. President :-
• No Executive powers
• Ensure laws follow the constitution
• Appoints PM and can terminate Congress
Prime Minister :-
• Has Executive powers
• Coordinate intelligence policies, determines the financial
resources and strengthens national cyber security
Parliament :-
• Bicarmel legislature
• Houses are Senate of Republic and Chamber of Deputies

6. Senate of Republic :-
• Upper house of parliament
• 315 elected Senators and 6 lifetime
senators
• Term of office is 5 years
Pallazo Madama
Pallazo Madama
Chamber of Deputies :-
• Lower house of parliament
• Has 630 seats, of which 618 are
elected from Italian constituencies
and 12 from Italian citizens living
aborad
Pallazo Montecitorio

7. DID YOU KNOW???

8. ECONOMICAL

9. The pharmaceutical industry is one of the main motors of Italy’s
economic recovery. Exports have reached a record high (a yearly
growth rate of 4.5%), and investments are on the rise along with the
sector’s employment.
The Italian pharmaceutical industry is second in Europe for
production volume and the first in the world for exports: +71% of
Italy’s production is exported.

10. Pharmaceuticals in Italy rank top in European manufacturing
With reference to the value of pharmaceutical manufacturing, Italy
ranks 2nd in big EU countries after Germany, but ranks 1st for per
capita manufacturing value.( 1 Euro = 74.9535 Rs)

11. Italy registered the highest increase in the world of
medicines export between 2010 and 2014
Italy could be the European pharmaceutical hub with policies
that make the country increasingly attractive to FDI

12. Pharmaceutical growth on international markets
The export growth is rooted in the high competitiveness of
manufacturing in Italy, which reflects investments by enterprises and
the quality of its Human Resources

13. 174 manufacturing plants
63,000 employees
(90% graduates)
and other 65,000 in upstream sectors
5,950 R&D employees
€ 29 billion of manufacturing value,
of which 72% for export (€20.7 billions)
€ 2.5 billion in investments,
of which €1.3 in R&D
and €1.2 in hi-tech plants and machinery
+71% export growth in the last 5 years
compared to +38% in overall manufacturing

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15. SOCIO-CULTURAL

16. • According to Giampaolo Zambeletti, chairman
of Ellem Industria Farmaceutica,
• Socio-cultural attitudes towards health care
provision has revealed a continued weakening
in the physician/ patient relationship over the
last 10 years
• The culture of prevention had been almost
completely absent among Italian health care
consumers

17. • Now people are better educated (Literacy
rate: 97%) in medical and pharmaceutical
matters, more interested in such matters and
more concerned about their own health
• For the pharmaceutical industry, these trends
point up the need to develop a new service-
oriented culture

18. Companies have develop new strategies that include:
– a full information service to the physician, including
education and updating
– drug information to include consideration of factors such
as the product's affect which varies over time, and
cost/benefit information;
– the concept of the "European" customer to be developed
and standardized, both directly and indirectly; and
– developing interactive communications, making them a
two-way exchange rather than simply coming from the
top.

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20. TECHNOLOGICAL

21. The technological factors relate to the application
of new inventions and ideas such as R&D activity,
automation, technology incentives and the rate of
technological change.

22. • Linking mail order internet technology with traditional pharmacies
into multi channel shopping experience
• Massive uptake of social media and smart phones
• Rapid growth in tech savy multi channel pharmacy shoppers
• Emergence of want it now shopper expectations using online
marketing services
• Good presence of online marketing service
• High percentage of R&D expenditure

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25. LEGAL

26. AIFA (Agenzia italiana del farmaco) 2004
The Italian medicines agency. It is the national authority responsible for drug
authority in Italy
It cooperates with the Regional Authorities, the National Institute of Health,
Research Institutes, Patients’ Associations, Health Professionals, Scientific
Associations the Pharmaceutical Industry and the Distributors.
The mission:
- Promote good health through medicines
More specifically, the Agency:
• Guarantees access to medicines and their safe and appropriate use.
• Ensures unity of the national pharmaceutical system in agreement with the
regional authorities;
• Ensures innovation, efficiency and simplification of the marketing authorization
procedures, in order to grant rapid access to innovative drugs and to drugs used
for rare diseases;
• Provides drug expenditure governance in the framework of economic and
financial viability and competitiveness of the pharmaceutical industry;
• Encourages investments in research & development in Italy;

27. • AIFA also verifies the implementation of national and European laws
regarding the distribution, importation, exportation and smooth
operation of early warning and emergency management.
• The phenomenon and the Database on thefts
In 2013 theft cases. In order to share and analyze data and information
on the phenomenon AIFA along with Ministry of Health, set up a
database on thefts, an archive constantly updated with data shared by
the over thirty companies participating in the project.
The Database, hosted and managed by AIFA, is available online to
authorized users (member companies and police forces).
• Stolen medicines
This section makes available information of medicinal products stolen in
Italy. The aim is to provide useful and timely updates to all operators in
order to intercept any "suspect offers," potentially related to illegal
activities.
• Training
Several training initiatives on the issue of counterfeiting and the
importation of illegal drugs have been organized and promoted by AIFA.
• E-Pharmacies
• Italian law prohibits e-pharmacies but can not prevent Italian customers
from buying from foreign e-pharmacies.

28. OTHER LAWS
• Italy's pharmaceutical patents were prohibited until 1978.
• After 1978 supreme court ruled in favour of 18 foreign pharmacy
companies requesting the enforcement of patents on medical products in
Italy.
• Despite of lack of any patent protection it has developed a strong
pharmacy industry and end of 1970 it was 5th world producer of pharma
and 7th exporter.
• 50% -80 % pediatrics drugs are not been tested on children or not been
licensed, in this case physician have to take responsibility
• Marketing authorization no EU nine digits
• A pharmacy company needs to be registered and incorporated at relevant
tax authorities. Pharmaceutical products are subject to VAT (10% -21%)
• Two procedures available national procedure and community procedure

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30. ENVIRONMENTAL ANALYSIS
Environmental contamination by pharmaceuticals is
an emerging issue.
Pharmaceuticals waste are widespread
contaminants, entering the environment from a
myriad of scattered points.
The sewage system is an important point in the
control of contamination, but sewage treatment
plants are not able efficiently to abate a substantial
part of water-borne pharmaceuticals.

31. Grazie!!!