ARTICLE
17 January 2015

Turkey's New Life Sciences Strategy: Focusing On Local Manufacturing Of Medicines

EA
Esin Attorney Partnership

Contributor

Esin Attorney Partnership, a member firm of Baker & McKenzie International, has long been a leading provider of legal services in the Turkish market. We have a total of nearly 140 staff, including over 90 lawyers, serving some of the largest Turkish and multinational corporations. Our clients benefit from on-the-ground assistance that reflects a deep understanding of the country's legal, regulatory and commercial practices, while also having access to the full-service, international and foreign law advice of the world's leading global law firm. We help our clients capture and optimize opportunities in Turkey's dynamic market, including the key growth areas of mergers and acquisitions, infrastructure development, private equity and real estate. In addition, we are one of the few firms that can offer services in areas such as compliance, tax, employment, and competition law — vital for companies doing business in Turkey.
In November 2014, Turkey unveiled its Action Plan for Structural Reform in Health Industries.
Turkey Food, Drugs, Healthcare, Life Sciences

Recent developments

In November 2014, Turkey unveiled its Action Plan for Structural Reform in Health Industries. The Action Plan, a component of Turkey's tenth five-year development plan (2014 - 2018), focuses on developing local medicinal product manufacturing.

Implications for pharmaceutical and medical device companies

Pharmaceutical and medical device companies selling products manufactured abroad could find competing in the Turkish market more difficult in the near future.

What the Action Plan says

Turkey has long suffered from a high current account deficit, a significant cause of which is the import of medicines. According to the Action Plan, to incentivize local manufacturing, the Turkish government will:

  • develop strategies for the pharmaceutical and medical device industries;
  • establish a Health Industries Orientation Committee and a Health Institutes Authority;
  • introduce financial incentives for public healthcare institutions to procure locally-manufactured products;
  • prioritize locally-manufactured products through licensing, pricing and reimbursement procedures;
  • favor export products in reimbursement applications;
  • introduce incentives for researchers to participate in clinical trials;
  • introduce incentives for R&D and clinical trials;
  • develop technical and legal infrastructure for orphan drugs;
  • improve the legal and regulatory environment for off-set and local manufacturing, particularly for biotech products;
  • introduce incentives for investments in Class II and Class III medical products and biotech medicines;
  • seek bilateral agreements with other countries to facilitate the marketing authorization process for products manufactured in Turkey; and
  • promote the Turkish healthcare industry abroad.

Actions to consider

Pharmaceutical and medical device companies should:

  • consider whether manufacturing their products in Turkey would be necessary to maintain competitive strength in the Turkish market; and
  • closely follow off-set opportunities, local manufacturing incentives and changes to Turkish pharmaceutical and medical device regulations in Turkey.

Additionally, pharmaceutical companies and clinical trial contract research organizations should closely follow the development of clinical trial incentives in Turkey.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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