In the current COVID-19 crisis medical device companies continue to prove support to healthcare professionals, healthcare organizations, healthcare systems and governments in order to fulfill the urgent needs. However, the local regulations and codes of conduct for the industry on relationship between the medical device companies and governmental organizations are still in force. Therefore, it is likely that some actions taken by the medical device companies in response to…
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The coronavirus (Covid-19) crisis has created extraordinary circumstances that require substantial additional resources and an increased availability of vitally important medical devices. However, none of this could reasonably have been anticipated at the time of adoption of the Medical Device Regulation numbered (EU) 2017 /745 (“MDR”) to be in the force on 26 May 2020.
In this regard, on 3 April 2020, the European Commission has adopted a proposal to postpone by one year the…
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Article 85(3) (c) of the Industrial Property Law excludes marketing authorisation applications from the scope of patent rights. However, the IP courts’ interpretation of this has been disproportionately weighted against patent holders.
Generic pharmaceutical companies can obtain a marketing authorisation by carrying out a number of procedures before the Ministry of Health. As a result, entities that apply for a marketing authorisation seven to eight months before the…
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With Turkey having a population of 80 million that is covered by an extensive social healthcare system, the size and volume of the Turkish life sciences industry is significant.
Despite many opportunities that accompany this potential for growth, it should also be noted that both the Turkish pharmaceutical and medical device industries remain heavily regulated in all aspects, ranging from market access, to pricing and reimbursement being covered by industry-specific…
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Healthcare and pharmaceuticals make up a highly regulated industry sector in Turkey, and the pricing of medicines is no exception. The prices of medicines that are to be marketed in Turkey are set in accordance with the Decision on Pricing of Human Medicinal Products (“Decision”) and the Communiqué on the Pricing of Human Medicinal Products (“Communiqué”) of 29 September 2017, issued by the Ministry of Health (“MoH”) who is vested with the competencies to regulate the…
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In Turkey, the innovator pharmaceutical market is dominated by originator companies of foreign origin, with local companies active in the generics market. The government’s unease with the emphasis on imported products in the Turkish market beckoned the state development plan to procure local production in the pharmaceutical market, a political act affecting the activities of many pharmaceutical companies of foreign origin.
The aforementioned state development plan triggered…
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