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 2014, marking a 5% compound annual growth rate according to researches. The global pharmaceutical industry revenue is forecasted to reach an estimated $1,226.0 billion by 2018, with good growth over the next five years (2013-2018). 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 17 emerging pharmaceutical markets such as China, India, Russia, Brazil and Turkey, predicted to grow at a rate of around 16% 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 world’s top ten economies in health services by 2023 by increasing R&D expenditures to 3% of GDP and by increasing exports to USD 500 billion. Turkey’s “Health Care Transformation Program” that was implemented in 2004 marked a major development in public access to health services and treatments. Physician consultation per capita increased five times from 1.7% in 1994 to 7.7% in recent year. The average life span in Turkey also increased 24% in the last 30 years and has now reached 74 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 Forum’s Global Competition Index (2011-2012), Turkey is ranked 59 out of 142 countries, and ranked 71 in the Innovation Capacity Index. While the Turkish pharmaceutical sector is ranked 16th in terms of market value, it is 36th 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;
1- 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.
2- 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 activitie;
- Advising on issues of antitrust law;
- Advising on liability issues.
3- 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.
4- 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.
5- 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.
6- 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.
7- 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.
8- Matters related to research and development
- Negotiating, drafting and reviewing research and development agreements;
- Advising on employee inventions.
