Description
Health &
Pharmaceuticals
The global market for pharmaceutical
goods is increasing due to an aging population, advances in
drug-based treatment research, increased investment in healthcare
and consumer-driven private health coverage, and rising numbers of
patients. There are also major challenges such as price pressures,
strict regulation, lawsuits and expiring patents those market
growth faces.
The global pharmaceutical industry
is expected to be worth more than $1 trillion in ***4, marking a 5%
compound annual growth rate according to researches. The global
pharmaceutical industry revenue is forecasted to reach an estimated
$1,**6.0 billion by ***8, with good growth over the next five years
(********8). The industry is expected to register growth led
primarily by aging population, changing lifestyles, hectic daily
activities, unhealthy eating habits, increasing incidence of
chronic diseases across the entire global population providing
opportunities for the industry players to grow.
America is leading the global
pharmaceutical market and is followed alternately by the Japanese
and European markets. According to research by the International
Federation of Pharmaceutical Wholesalers (IFPW), there are
significant disparities between growth rates in developed and
emerging markets based on their capacity to bounce back from the
economic crisis. This includes *7 emerging pharmaceutical markets
such as China, India, Russia, Brazil and Turkey, predicted to grow
at a rate of around *6% largely due to an increase in healthcare
spending by government, and private and public bodies according to
researches.
Turkey aims to become
one of the worlds top ten economies in health services by ***3 by
increasing R&D expenditures to 3% of GDP and by increasing
exports to USD **0 billion.
Turkeys Health Care
Transformation Program that was implemented in ***4 marked a major
development in public access to health services and treatments.
Physician consultation per capita increased five times from 1.7% in
***4 to 7.7% in recent year. The average life span in Turkey also
increased *4% in the last *0 years and has now reached *4 years.
This in mind, Turkey might implement the necessary structural
changes and effectively promote innovation in the health care
system to make the pharmaceutical industry the driving force to
achieve its economic objectives.
According to the World
Economic Forums Global Competition Index (********2), Turkey is
ranked *9 out of **2 countries, and ranked *1 in the Innovation
Capacity Index. While the Turkish pharmaceutical sector is ranked
*6th in terms of market value, it is *6th in terms of the clinical
research conducted and the volume of pharmaceutical
exported.
At Esmeray Law Office,
we can help medical and healthcare professionals with a wide range
of services tailored specifically to their needs.
We can assist on the
following matters;
*- Matters related to clinical
trials
- Negotiating, drafting and reviewing
of clinical trial agreements, investigator agreements, agreements
for research organisation,
- Advising on the regulatory issues of
clinical trials, especially necessary authorisations from the
competent authorities, committees.
*- Matters related to
co-marketing
- Negotiating, drafting and reviewing
of co-marketing agreements, co-promotion
agreements,
- Advising on the regulatory
requirements for contracts concerning joint sales
activities
- Advising on issues of antitrust
law
- Advising on liability
issues.
*- Matters
related to manufacturing, supply and services
- Negotiating, drafting and reviewing
of manufacturing agreements, supply agreements, service agreements
(consulting, logistics etc.), technical
agreements,
- Advising on the regulatory aspects
of contract manufacturing and the outsourcing of other activities
to third parties.
*- Matters related to licensing and
partnering
- Negotiating, drafting and reviewing
of licensing and partnering agreements, non-disclosure agreements,
letter of intent and term sheets
- Conducting due
diligences
- Advising on antitrust law in
licensing
- Advising on regulatory aspects of
contracts
- Resolution of disputes arising from
licensing and partnering agreements.
*- Matters related to product
liability
- Defense or settlement of product
liability claims regarding medicinal products or medical
devices
- Advising in connection with safety
objections raised by regulatory authorities
- Advising on the implementation of
corrective action such as product recalls, additional safety
instructions or temporary restrictions on
use.
*- Matters related to public
procurement
- Advising and acting for
pharmaceutical companies and medical device manufacturers in public
tenders,
- Advising and acting for
pharmaceutical companies and medical device manufacturer in review
procedures,
- Negotiating, drafting and reviewing
of business partnership, consortium and sub-contracting
agreements,
- Advising on the preparation of
tender documents.
*- Regulatory
- Advising on pharmaceutical and
medical device laws
- Advising on regulations relating to
manufacturing, approval and distribution of medicinal products and
medical devices,
- Advising on regulations relating to
data exclusivity,
- Advising on regulations relating to
intellectual property protection,
- Advising on regulations relating to
wholesale of medicinal products.
*- Matters related to research and
development
- Negotiating, drafting and reviewing
research and development agreements,
- Advising on employee
inventions.