The Turkish Medicines and Medical Devices Agency (“Agency”) published its Counterfeit, Contraband and out of the Legal Supply Chain Medicines (“Guide”), entering into force as of January 05, 2022.
Scope
This Guide covers the persons and entities who manufacture, import, export, store, distribute and sell the counterfeit, illegal medicines or medicines out of the legal supply chain and aims to define responsibilities of all actors when combatting against such medicine.
Objective
The Guide puts regulations on the method of notifications, evaluation and analysis process of the samples sent to the Agency, actions to be taken with regards to the counterfeit, contraband and out of the legal supply chain medicines, the procedure to follow when determined any illegal products, the destruction procedure, the actions to be taken by the Agency against the online promotion and/or sales of medicines and rapid alert notification.
In this regard, the Guide puts notification obligations on
- the market authorization holder,
- the directors of the pharmacy warehouses and pharmacies,
- hospital executives,
- medicine manufacture sites,
- doctors and other healthcare professionals,
- provincial directorates of health,
- patients
when they encounter any medicines which could be counterfeit, contraband or out of the legal supply chain.
Uncompliant Medicines
Uncompliant Medicines The Guide reinstates that any product which is determined to be uncompliant with the legislation by the Agency, the subject matter medicine shall be recalled from the pharmacies and the pharmacy warehouses and destruction procedure for such medicines and their promotional and advertising material shall be initiated.
Online Promotion and/or Sales of Medicines
Online promotion or sales activities of medicines are prohibited. The Agency is responsible for the detection of promotion or sales of medicines on websites. When online promotion or sales of medicines are detected, the Agency is under the obligation to obtain a shutdown order for the relevant website and/or websites and to notify this order to the Association of Access Providers for its execution. In addition, the Agency also notifies the related authorities to initiate all administrative and legal proceedings.
Within this regard, the Agency conducts ex-officio web controls to detect such online activities.
In addition, the Agency also examines any notification made by public to itself.
CONCLUSION
Even if the Guide sheds a light on the regulatory aspect of the life sciences and does not directly acknowledge a relationship with the intellectual property rights, it is still an important tool because it regulates strict notification and certain other obligations on all actors in the market. Therefore, it would play a role when negotiating with the counter parties engaging in counterfeiting by providing a leverage during such negotiations. The intellectual property right holders may still rely on their legal obligations to notify the Agency when trying to prevent counterfeiting acts, including the ones conducted online.
