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.
