Pharmaceutical market access in developed markets
: J Forensic Toxicol Pharmacol
The Market Access (MA) term was first introduced by the World Trade Organization (WTO) to define the competing relation between the domestic and the imported products of a country. The WTO defines MA as a set of conditions, tariff and non-tariff measures, agreed by WTO members for the entry of specific goods into their markets. Pharmaceutical market access is achieving the optimal price for a product or service and/or maximum reimbursement for the approved (Market Authorisation) target population with no restrictions on funding for the medical technology. As a result of these challenges current market access hurdles for medicinal products became more diversified in the last 2 decades and they can be simply categorized under two major types based on payer needs and capabilities: 1) Delaying access (long review processes, real life data requirements, cost-benefit assessment for smaller patient groups, Prioritization in Good Manufacturing Practice audits before registration submissions, unscheduled Review Committee Meetings, Regional/Hospital reviews, outcomes based managed entry agreements) and Controlling demand (local reimbursement guidelines, import license renewals/ limits, forced localization) 2) Increasing negotiation power for better pricing (cost-effectiveness and budget impact analysis, joint procurement, central tendering, hospital and retail separate budgeting, hospital formulary, efficiency analysis, Therapeutic equivalency band, Joint Health Technology Assessment(HTA) initiatives, unofficial price data sharing, reference pricing, financial based managed entry agreements). In summary, price pressure will continue on budget holders and known method of business, economy and sciences to be used by them in order to increase efficiency in decision making, Åayers will increase and access will be delayed inevitably, equity in access will remain problematic because of reimbursement filters by different local and regional payers, and across countries, lack of coordination among layers/regions/countries is obvious, but efforts will continue to harmonization, financial risk will shift more to pharma companies and increase access hurdles. End last but not least, hurdles are now starting before registration in many low affordability markets with other method of supply restrictions (GMP, import quotas, forced localization).
Guvenc Kockaya is a medical doctor and health economist. He earned Master of Science degree in Pharmacoeconomics & Pharmacoepidemiology at Yeditepe University and Doctorate degree in Clinical Pharmacology and Medical Pharmacology at Istanbul University. He completed the European Market Access Diploma Program at Lyon-1 University and studied as a short term fellow at Temple University’s Center for Pharmaceutical Health Services Research. He has established the ISPOR Yeditepe University Student Section. In 2011, he became the first Turkish citizen to be awarded the "ISPOR Meeting Travel Scholarship Award." He has several articles and posters that have been published in national and international journals or presented in national and international congresses. He has also served as the Turkish translation editor of Bootman`s Principles of Pharmacoeconomics and WHO`s Health Technology Assessment in Medical Devices. He worked for Ministry of Health of Turkey as health economist and was a member of Medical and Economic Evaluation Commission, which evaluates pharmaceutical reimbursement decisions. He worked also as head of market access or health economics department in pharmaceutical & medical device companies for Turkey and Middle East countries. He is the President of the Health Economics and Policy Association (HEPA) and plays an active role in the development of health economics in Turkey and a member of scientific advisory board of “Farmeconomia. Health economics and therapeutic pathways”. He is the editor of the books titled as “Pharmaceutical Market Access in Emerging Markets” and “Pharmaceutical Market Access in Developed Markets”. He is now working for CarthaGenetics, a Switzerland based Consultant Company as market access director for Europe, Turkey, Middle East and North Africa.