Sponsored briefing: Life sciences in Turkey

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

Sponsored briefing: Independent power projects in Africa

Sponsored briefing: Independent power projects in Africa

Miranda’s Nuno Cabeçadas (pictured, left) and Renato Almeida (pictured, right) discuss trends and developments in Angola and Mozambique

Throughout the world, one of the main goals of different governments and industry is to enhance the use of renewable energy. Africa, in general, is no exception, particularly Angola and Mozambique. In effect, in these two countries’ governments are working towards the promotion and acceleration of private and public investment in new renewable energy. As spelled out in the Angola Energy 2025 programme, one of the goals is to generate effective conditions of investment in new renewable energy, eliminating or dramatically reducing the distortion introduced by subsidies to fossil fuels, offering a suitable payback to investments, an appropriate mitigation of risks and a regulation that eases implementation and commits investors. Continue reading “Sponsored briefing: Independent power projects in Africa”

Sponsored briefing: Growing interest in asset deals

Sponsored briefing: Growing interest in asset deals

Yegan Liaje of Pekin & Pekin describes a rising interest in asset deals following a period of economic uncertainty in Turkey

Turkey has faced some serious financial challenges in recent years, such as high inflation, currency collapse and rising borrowing costs; however, surprisingly, these challenges have not dramatically affected the Turkish M&A market in terms of total transaction volume; though, we have noticed that it has affected the deal type in which investors have gained interest. In the last two years, we have experienced asset deals attracting more attention in the eyes of investors, despite share deals still having more advantages. Although investors do not have to bother with costly revaluations and retitles of individual assets, and can typically assume non-assignable licenses and permits without having to reapply for the same licenses and permits in share deals, asset deals also have some noticeable benefits.

Probably the most appealing advantage of asset deals is to enable buyers to pick and choose what they want to buy in the relevant target company without being bound to the whole company, all the unwanted remaining assets and certainly their unwanted liabilities. In other words, asset deals provide a playing field for investors where they can freely choose what suits best their business insight, in contrast to share deals where the shares of the target company are purchased with all attached shareholding rights and obligations, but the target company would remain liable against third parties for all historic claims.

On the other hand, asset deals do have some procedural disadvantages as well; each category of asset and liabilities subject to the relevant asset deal will be evaluated separately for consent requirements or formal perfection requirements rendering asset deals procedurally more burdensome. Furthermore, even where there are no consent requirements or formal perfection requirements, notifications would have to be provided to creditors in order to prevent good-faith payments made by creditors to the seller with respect to acquired assets, since under the Turkish Code of Obligations, such good-faith payments would discharge the debts of creditors who were not informed of the transfer. One more interesting point about asset deals in Turkey: as per the Turkish Labour Code, in the event that a workplace is transferred to another legal body on the basis of a legal transaction, the employment contracts that exist at the workplace at the date of transfer are automatically transferred to the transferee together with all rights and obligations. Therefore, buyers are not able to pick and choose when it comes to employees!

For more information, please contact:Yegan Liaje, senior partner, M&A

Pekin & Pekin
10 Lamartine Caddesi
Taksim 34437 Istanbul

D: +90 212 313 35 48
T: +90 212 313 35 00
F: +90 212 313 35 35
E: yliaje@pekin-pekin.com

www.pekin-pekin.com

Sponsored briefing: Economic crisis and the popularisation of voluntary termination of labour contracts

Sponsored briefing: Economic crisis and the popularisation of voluntary termination of labour contracts

Murat Uyanık of Yavuz & Uyanık discusses Turkish labour law developments

Turkey’s progress towards full membership of the EU had gained pace by the beginning of the 2000s. To achieve full legislative alignment with the EU acquis, the Turkish labour law was renewed and a new concept was introduced to the country’s labour law sphere: employment protection. Continue reading “Sponsored briefing: Economic crisis and the popularisation of voluntary termination of labour contracts”

Sponsored briefing: Med-arb: a hybrid approach to ADR and its applicability in Turkey

Sponsored briefing: Med-arb: a hybrid approach to ADR and its applicability in Turkey

Matur & Ökten’s Bahar Nalan Danış discusses combining mediation and arbitration

Today’s world is changing at a dazzling speed, and so is the way we deal with disputes. Although originating from thousands of years ago, we may well state that alternative dispute resolution (ADR) in its modern meaning was developed in the 20th century and has continued to evolve ever since, due to its fast solution-providing rate, which suits the requirements of modern business life.

In the last few decades, different forms of ADR have gone global. The forms that make up ADR include mediation, arbitration, negotiation, ombudsman services, consensus building and new hybrids of these processes, including med-arb, which features characteristics of both mediation and arbitration.

Brief background

Before reviewing the essence of med-arb, it is important to understand the meaning of each process, as well as their growth as ADR processes.

Mediation and arbitration have operated separately for many years. Mediation is the procedure wherein a neutral and impartial professional acts as a mediator, who facilitates the communication between conflicted parties and assists them to find a resolution. If the matter is resolved, parties sign a binding agreement. The advantages of mediation are that the parties craft their own solution and it is more affordable. The most common criticism addressed to mediation is that it does not guarantee a final resolution.

Arbitration, on the other hand, is more of a court-like process, where parties attend hearings, submit evidence, etc, based on which the arbitrator makes a binding decision. The benefit of arbitration is that it is faster and more efficient than traditional litigation. It is, however, criticised for being adversarial and the parties have limited control of the resolution.

The two methods can seem pretty different from each other in terms of the principles they rely on and how they work, yet great results are produced when they are combined together. The parties are guaranteed an outcome in med-arb, either through mediation or arbitration. Therefore, interconnecting mediation and arbitration can save time and cost in settling. It has become the most applied form of combined ADR processes over time, with an increased attention in the recent years, especially after the successful examples set by IBM v Fujitsu and Federal Deposit Insurance Corporation v Cherry Bekaert & Holland.

Two worlds colliding

Med-arb can be applied in different ways, the most common of which is the conduct of mediation and arbitration consecutively. In this method, the parties first try to resolve their dispute through mediation, aka ‘pre-arbitral mediation’. In case no understanding can be reached fully or partially within the pre-specified period or the time determined by the mediator/med-arbiter, parties continue with arbitration for the whole dispute or partially for the sections they cannot agree on. It is statistically shown that most cases of med-arb turn into successful mediations with no requirement for arbitration.

It is possible for both stages to be followed up by the same person who acts as the med-arbiter, which is known as the ‘med-arb same’ model. Or, a mediator and an arbitrator manage each respective phase, which is the ‘med-arb different’ model.

Turkish practice

Arbitration in Turkey is regulated under the International Arbitration Law No. 4686, dated 2001, whereas mediation is a much newer concept introduced to Turkish law in 2012 via Law No. 6325 on Mediation in Civil Disputes (Mediation Law). Neither law specifically refers to med-arb as a dispute resolution method, however it can be understood from the wording of Article 5/1 of the Mediation Law that there is no obstacle to applying arbitration following the mediation process. The said article, taking its basis from Article 10 of UNCITRAL Model Law on International Commercial Mediation, stipulates that ‘parties, mediator or third parties cannot allege the followings as evidences or testify as witness on these, when a lawsuit is filed or arbitration is resorted to regarding the dispute’.

On the other hand, Turkey passed Law No. 7155 on Legal Proceedings for Monetary Receivables of Subscription Agreements, which became effective as of 2019, requiring ‘mandatory mediation’ for commercial cases as a prerequisite before filing legal action. According to Article 23/18 of the cited law, in cases where there is an arbitration clause, such compulsory mediation condition shall not apply.

As for the question of whether a mediator can act as a med-arbiter under Turkish law, Communiqué on the Mediation Law dated 2013 set forth in Article 12/4 that the mediator cannot assume later the duty of an arbitrator in relation to the same dispute. This Communiqué was abolished and replaced with a new one in 2018, which does not refer to such prohibition. On the contrary, it is specified in Article 4/6 of Mediators’ Ethic Rules announced by the General Directorate of Mediation that the mediator can actually act as an arbitrator if the parties in conflict agree so in writing.

A first in the world: groundbreaking move from Turkey

As an exciting new development, the Istanbul Arbitration Centre (ISTAC) has just published rules governing med-arb on 15 November 2019 on its website, which has become the world’s first institutionalised written med-arb rules. By presenting the ‘first of its kind’ rules, ISTAC aims to widen the prevalence of med-arb.

We have witnessed many commercial disputes, both local and multinational, being settled in Turkey, especially in Istanbul via arbitration.

Med-arb can be more effective than arbitration indeed, as the parties will participate in the mediation phase in sincerity and good faith, knowing that if they fail to reach an agreement, they will lose control over the outcome and have to go along with the med-arbiter/arbitrator’s decision. It can also be more efficient than mediation, since parties will be more likely to assert reasonable demands and demonstrate a more conciliatory attitude than in mediation alone, increasing the opportunity for a more satisfying result for all involved.

We hope this two-tier system will also become a preferred choice of settlement in Turkey in the years to come.

For more information, please contact:

Bahar Nalan Danış, attorney at law – mediator (Young Mediators Initiative of the International Mediation Institute)

Matur & Ökten & Karayel Keßler Law Office

İnönü Cad No:24/4

Gümüşsuyu, Taksim

Beyoğlu

Istanbul

T: +90 212 260 1062

E: bahar.danis@maturokten.com

www.maturokten.com

Sponsored briefing: Turkey M&A outlook: 2020 and beyond

Sponsored briefing: Turkey M&A outlook: 2020 and beyond

Gamze Çiğdemtekin (pictured, left) and İpek Batum (pictured, right) of Çiğdemtekin Çakırca Arancı assess what lies ahead for the deals market over the next few years

Global economic uncertainties have affected the M&A market, and the recession in the Turkish market was as expected for 2019. According to the data reported on M&A transactions in 2019, the volume of the total M&A transactions in Turkey was $7.4bn. While many economists predict the M&A market may slightly fall in 2020, Turkey’s New Economic Program has optimistic targets that give confidence to investors to take advantage of the current market and expect higher returns in the next three years. Furthermore, there are significant opportunities still available for investors, with emerging sectors taking the spotlight. Continue reading “Sponsored briefing: Turkey M&A outlook: 2020 and beyond”

Sponsored briefing: Notable developments in Turkey’s oil and gas policy

Sponsored briefing: Notable developments in Turkey’s oil and gas policy

Yazıcı’s Kerem Arıç explores three key areas of growth for the country’s energy sector

Due to its dependence on oil and natural gas imports, Turkey has been in need of structural changes in its energy sector. Although the share of natural gas in power generation was significantly reduced in 2019, the overall reliance on natural gas and oil imports creates major challenges both from a commercial and strategic perspective. To overcome these challenges and increase its energy security, the Turkish government made a fundamental decision to move from a role of investor to a role of policy maker and regulator. As a result, Turkey’s oil and gas policy has been mainly driven by the following ground rules: Continue reading “Sponsored briefing: Notable developments in Turkey’s oil and gas policy”

Sponsored briefing: Mediation on the rise in Turkey

Sponsored briefing: Mediation on the rise in Turkey

Eda Cerrahoğlu Balssen (pictured, left) and Sezin Dündar (pictured, right) of Cerrahoğlu discuss the legal requirement for mandatory mediation in commercial disputes

Turkey was introduced to mediation in 2012 with the adoption of Law No. 6325 on Mediation in Legal Disputes (Mediation Law), which regulates the mechanism of voluntary mediation. Continue reading “Sponsored briefing: Mediation on the rise in Turkey”

Sponsored briefing: Notable developments in construction law and practice

Sponsored briefing: Notable developments in construction law and practice

Yazıcı’s Bilge Müftüoğlu on the effect of government incentives on the energy sector

There are major criteria that investors consider in advance of determining the type and extent of their investment in any sector and the energy sector is no different. Incentives granted by states are one of these as they have considerable impact on construction contracts of projects involving infrastructure and energy, such as power plants. Continue reading “Sponsored briefing: Notable developments in construction law and practice”