Sponsored briefing: Restrictive measures against Turkey by the EU

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Sponsored briefing: Restrictive measures against Turkey by the EU

Vona Law Firm’s Gül Özdinç sets out a criticism of the European Council’s new regulation concerning restrictions on Turkey

The European Council adopted a framework for restrictive measures against Turkey for its drilling activities in the Eastern Mediterranean with Regulation (EU) No 2019/1890 of 11 November 2019.

The framework will make it possible to sanction individuals or entities responsible for or involved in drilling activities of hydrocarbons in the area. The sanctions consist of a travel ban to the EU, and an asset freeze for persons and for entities. And yet the framework did not refer to any names of individuals and entities. According to the regulation, the definition will be based on the following items:

a) Being responsible for or involved in, including by planning, preparing, participating in, directing, or assisting, drilling activities in relation to hydrocarbon exploration and production, or hydrocarbon extraction resulting from such activities, which have not been authorised by the Republic of Cyprus within its territorial sea, in its exclusive economic zone or on its continental shelf, including in cases where the exclusive economic zone or continental shelf has not been delimited in accordance with international law with a state having an opposite coast, activities which may jeopardise or hamper the reaching of a delimitation agreement.

b) Providing financial, technical or material support for drilling activities in relation to hydrocarbon exploration and production, or hydrocarbon extraction resulting from such activities, referred to in point (a).

c) Being associated with the natural or legal persons, entities or bodies referred to in points (a) and (b).

The regulation refers to funds and economic resources together: cash, securities, bonds, rights of set-off, letters of credit and bills of lading, and any kind of asset, whether tangible or intangible, movable or immovable, which are not funds but may be used to obtain funds, goods or service.

The regulation aims to prohibit almost all commercial activities with sanctioned individuals or entities, unless authorised by the regulation or by the relevant competent authority. The competent authorities may authorise the release of certain frozen funds or economic resources under such conditions as they deem appropriate according to the regulation.

It is obvious that both parties need each other: whereas the European bloc needs to co-operate with Turkey on migration, NATO, countering terrorism and energy transmission, Turkey needs the EU to continue its commercial activities. Our consideration is that the regulation violates international law and procedures of the UN Security Council, and we believe that the related parties will finally reach a common understanding that may satisfy all parties looking from different perspectives.

Currently, the EU has not published a name list and we do not see a practical reason not to continue trading with Turkey. However, Vona recommends its clients prepare their security nets by defining counterparties that could be a potential target of the sanctions and analysing the risks under the current relations, and setting out a plan B in case the counterparty is listed by the council.

For more information, please contact:Gül Özdinç, partner

Vona Law Firm

Caddebostan Mah Prof Dr Hulusi Behçet
Cad No: 14 K: 7 D: 8

Kadıköy

34728 Istanbul

E: gul@vonahukuk.com
T: +90 216 372 2816 (E: 23)

www.vonahukuk.com

Sponsored briefing: Obligation to register before the Turkish data controllers registry and maintain personal data-processing inventory

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Sponsored briefing: Obligation to register before the Turkish data controllers registry and maintain personal data-processing inventory

Yasin Beceni and Susen Aklan of BTS clarify Turkey’s data protection regulations on data controller registry obligations

Article 16 of Law no. 6698 on the Protection of Personal Data (DP Law) introduced a general obligation on data controllers to register before the Data Controllers Registry that is to be maintained by the Turkish Data Protection Board.

Obligation of foreign data controllers to register before the Registry

With the Regulation on the Data Controllers Registry and a number of board decisions, the board determined the scope of the obligation of registration and clarified the types of data controller that would be under the obligation to register. As per the regulation and the board decisions, it has been determined that no exemptions shall apply to foreign data controllers acting as data controllers1 pursuant to Turkish data protection legislation and that all such foreign data controllers must carry out their registration processes by the deadline of 31 December 2019.

Obligation to maintain Personal Data-Processing Inventory

All data controllers under the obligation to register must maintain a data processing inventory, a document that is similar in format to records of processing maintained as per Article 30 of the General Data Protection Regulation (GDPR). Stated in the table opposite is a comparison of the inventory and records of processing.

1. Unlike Article 3/2 of GDPR, there is no explicit provision regulating territorial scope under the DP Law. However, under certain decisions of the board, Article 3/2 is taken as a reference on interpretation of the DP Law.

Records of processing Inventory
Obligation An enterprise or an organisation employing fewer than 250 persons is not obliged to maintain records of processing unless the processing:
• is likely to result in a risk;
• is not occasional;
• includes special categories of data or personal data relating to criminal convictions and offences.The processor and processor’s representative will maintain a record of processing.		 All data controllers under the obligation to register must maintain an inventoryProcessors are not obliged to maintain an inventory
Contact details Name and contact details of the controller, the joint controller, the controller’s representative and the data protection officer Not explicitly stated. However, contact details of the controller and the controller’s representative should be submitted to the registry.
Purpose Purposes of processing Purposes of processing
Personal data Categories of personal data Categories of personal data
Data subjects Categories of data subjects Categories of data subjects
Recipients Categories of recipients to whom the personal data has been or will be disclosed, including recipients in third countries or international organisations Categories of third-party recipients
Cross-border transfers Identification of that third country or international organisation and the documentation of suitable safeguards Categories of personal data transferred abroad
Retention Envisaged time limits for erasure of the different categories of data Maximum retention periods
Security A general description of the technical and organisational security measures Administrative and technical measures
Legal ground N/A Legal grounds of the processing

For more information, please contact:Yasin Beceni, managing partner – attorney at law

E: yasin.beceni@bts-legal.com

Susen Aklan, managing associate – attorney at law

E: susen.aklan@bts-legal.com

BTS & Partners

www.bts-legal.com

Sponsored briefing: Life sciences in Turkey

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Sponsored briefing: Life sciences in Turkey

Özge Atılgan Karakulak and Dicle Doğan of Gün + Partners explain how the country’s growing healthcare and pharma industries operate under current regulations

Having a population of 80 million covered by an extensive social healthcare system, Turkey’s life sciences industry is still important in size and volume.

Both the Turkish pharma and medical device industries are heavily regulated and mostly in line with EU regulations. All aspects ranging from market access to pricing and reimbursement are being covered by industry-specific regulation. The relevant bodies enforcing these regulations are the Ministry of Health (MoH), the Turkish Medicines and Medical Devices Agency established under the MoH, and the Social Security Institution (SSI).

An increase in the quality of health services and access to pharmaceuticals has inevitably and consequently increased the demand, and also resulted in an increase in public spending. This circumstance has forced the government to look for ways to rein in public spending, by incorporating rigid pricing and reimbursement policies. Indeed the SSI requests a serious discount for reimbursements, which reaches up to 41% for innovative drugs.

These pricing and reimbursement difficulties have created a barrier to access to pharmaceutical products. Procurement from abroad of pharmaceuticals via named patient programmes, which is defined as an exceptional importation of drugs, has also led to extra expenditure on the health budget. Additionally, in order to control the budget, the SSI have developed alternative reimbursement models and implemented localisation policies. Nevertheless, the healthcare industry regulation in Turkey is mostly aligned with worldwide standards.

Marketing authorisation of pharmaceuticals

Marketing authorisations of pharmaceuticals is governed by the Regulation on Licensing of Medicinal Products for Human Use. For placing a pharmaceutical product on the market, additional regulations, such as the Regulation on Labelling and Packaging of Medicinal Products for Human Use and the Regulation on Safety of Medicines, will also be applied.

No medicinal product for human use can be marketed unless it is granted a marketing authorisation (licensed) by the MoH. Abridged applications are also possible in Turkey under the conditions set forth in the Licensing Regulation. The MoH follows the European common technical document format (including five modules) for the application files. The Licensing Regulation envisages a 210-day period for the evaluation of the licence application by the MoH following the preparation of all required documents. In practice, however, this may go up to two years or more due to the good manufacturing practice certification rules of the MoH, which require that each manufacturing facility be audited by MoH personnel.

Pricing of pharmaceuticals and the fixed exchange rate

The prices of pharmaceuticals to be marketed in Turkey are set based on a reference pricing system, whereby the cheapest wholesale price in one of the listed EU countries for the same product is taken as the wholesale price in Turkey. Although to determine the prices of pharmaceuticals in Turkish lira, the currency of the defined wholesale price is converted into Turkish lira, the conversion is not made according to the current exchange rate. In order to avoid the reflection of exchange rate fluctuations on the prices of pharmaceuticals, the MoH issue a fixed exchange rate to be applicable in the pricing of medicines. However, the exchange rate defined by the MoH applied to the reference price taken from the respective EU country gives out a much lower price than if it was converted at the current rate. The rate for 2019 was determined as TRY 3.40 by the MoH. On the other hand, the current exchange rate for the euro is TRY 6.34 on average in 2019.

Market access

Until recently, there was no direct contractual relationship between the SSI and the pharmaceutical companies regarding the pharmaceuticals purchased by the state. The pharma companies applied for the reimbursement of their products to the SSI and once listed, the pharma companies sold their products to the warehouses, which distribute the products to the hospitals and pharmacies. In line with this sales and distribution chain, the SSI reimburses the hospitals or the pharmacies the price of the listed products.

With the enactment of some regulations in the past couple of years, alternative reimbursement models have also become a hot topic in the Turkish healthcare industry, allowing the pharma companies and the SSI the benefit of discussing the terms and conditions of an alternative reimbursement model for special products. The system aims for the ultimate purpose of providing quicker access for patients to innovative pharmaceuticals along with ensuring their reimbursement.

Advertisement and promotion

According to the Regulation on Promotional Activities of Medicinal Products for Human Use, any advertisement of pharmaceuticals to the general public is prohibited, whether made directly or indirectly, through any public media or communication channels, including the internet. The promotion of pharmaceuticals shall be made only to physicians, dentists and pharmacists. The interaction between the pharma companies and patients shall therefore be at a minimum level.

The advertisement and promotion of medical devices is regulated by the Regulation on the Sales, Advertisement and Promotion of Medical Devices. Accordingly, medical devices that must be used or administered exclusively by healthcare professionals and medical devices within the scope of the reimbursement cannot be advertised to the public, either directly or indirectly. However, the advertisement of devices intended for personal use and that do not fall within the scope of reimbursement is allowed.

Both promotion regulations regulate promotional materials, scientific and educational activities, sponsorships, free samples and donations to healthcare organisations.

For more information, please contact:

Özge Atılgan Karakulak, partner

T: + 90 (212) 354 00 24

E: ozge.atilgan@gun.av.tr

Dicle Doğan, managing associate

T: + 90 (212) 354 00 24

E: dicle.dogan@gun.av.tr

Gün + Partners Avukatlık Bürosu

Kore Şehitleri Cad. 17

Zincirlikuyu 34394

Istanbul

www.gun.av.tr