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.
