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.