Market access conditions have considerable importance for pharmaceutical, medical equipment, and healthcare companies to make investment decisions. Market access conditions exist in a broad range, including obtaining authorizations for products such as pharmaceuticals and acquiring CE certificates for medical
It is essential to determine the pricing of the pharmaceuticals, medical devices, and health services and the payers as institutions or persons that will reimburse them, considering that 85 % of health expenditures are made by the public sector in Turkey and across Europe. On the other hand, the out-of-pocket market is bigger than the public sector in the Middle East, North Africa, and Western Asia.
All ventures and start-ups in this field, should develop their market access strategy and tactics for securing their market access strategies. With our experience on market access in the healthcare field, market access requirements of health start-ups are analyzed rapidly in accordance with thelegislation, and required activities are conducted by being in close relationships with
relevant public institutions.
Primary supports that we provide within this framework, are as follows:
- Examples of the market access process management activities;
- Preparing a license application file for the submission to be made before the relevant Medicines and Medical Devices Agency and the Ethical Committees.
- Monitoring the license application process, informing the firm regarding the authorization process at regular intervals.
- Preparing GMP audit application files for the products to be manufactured in the region.
- Lodging an application for GMP audit regarding the products to be imported and obtaining import permits, technically controlling the files of import licenses, evaluating and reporting their compliance with legislation.
- Determining the pricing strategy of products in line with current accepted pricing policy in relevant countries, making the relevant application, monitoring the whole process, and informing the company about the process at regular intervals
- Identifying the required steps for the market access of the product that will be developed, budgeting, and managing relevantly.
- Making variation applications of the licensed products and the products whose licensing process still continues.
- Monitoring current reimbursement policies and reporting up-to-date reimbursement policies. In this direction, preparing the reimbursement application file in compliance with the procedures and principles set forth as per the relevant legislation, lodging reimbursement application to Social Security Institution,
monitoring all the application process, and informing the firm concerning the process at regular intervals.
- Providing an expert opinion on the price differences arising due to pharmaceutical product prices above the
reimbursement prices in line with the pricing and reimbursement policies in Turkey,
preparing a budget plan within this scope.
- In case that the authorization request is rejected, initiating the objection process and management of the process against the rejection decision.