Medicines And Medical Devices Agency Applies To PIC/S Scheme
BMI View: While it appears that Turkey is responding to industry concerns over its hostile position on GMP inspections, the reality is that accession to PIC/S is still many years off and furthermore, requires mutual recognition treaties between countries to have meaningful impact on pharmaceutical trade. Turkish regulations will continue to stifle market access and discriminate against foreign drugmakers in the medium term.
The state regulatory body on pharmaceuticals in Turkey, the Medicines and Medical Devices Agency (MMDA) officially submitted its application to the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) on Tuesday 14th May. In our previous reporting on Turkey, we highlighted the country's listing as the Foreign Priority Country by PhRMA in its annual report to the office of the US Trade Representative (USTR).
PhRMA has raised the issue of Turkey's policy on recognising GMP certificates repeatedly in the US and in Turkey. Currently, the MMDA requires GMP certificates for drug registration procedures. However, Turkey does not mutually recognise international, ISO-certified GMP certificates unless a firm's domicile country has a mutual recognition treaty for Turkish GMP certificates, which neither the EU nor the US does currently. Therefore, multinational drugmakers must wait for Turkish inspectors to approve their manufacturing facilities before they can register drugs with the MMDA. Given the small number of Turkish inspectors and the massive backlog of inspections to be carried out, this is in effect a de facto ban on imports. This policy carries official Turkish state sanction, as part of the AKP's policy of promoting Turkey as a manufacturing hub and reining in its current account imbalances.
However, given that the average time to accession to PIC/S is between 4-6 years, the impact on the pharmaceutical sector in Turkey will be limited and only realised in the long term. The PIC/S treaty is non-binding and is essentially an informal agreement between regulatory agencies; the FDA and EMA still perform inspections globally and do not mutually recognise inspections from foreign regulatory agencies. However, what PIC/S does enable is facilitate improvements in GMP as the training and knowledge sharing by members facilitates better and quicker inspections. But the lack of a legally binding agreement on mutual recognition means that countries must arrange bilateral mutual recognition treaties within trading blocs or on a one-to-one basis; ASEAN regulatory agencies have agreed to mutually recognise inspections on the basis of PIC/S membership, but have not extended this recognition outside the region.
While on face value, it may seem that Turkey is responding to the industry's concerns over its serious market access barriers, the reality is that any shift away from current policies will take much longer to implement. The MMDA will continue to stifle access of innovative drugs from multinationals onto the Turkish market, and pricing and reimbursement policies will continue to discriminate heavily against foreign drugmakers. Without a radical shift in policy from the cabinet and the Ministry of Health, gestures such as these will do little to improving the operating environment for foreign drugmakers within Turkey.