About

What are the most important transactions and litigations that you have been involved in during the last two years?

I have been involved in several major transactions and litigations within the last two years period. However, I can say three of these cases can be considered as milestones in my career. Given the strict confidentiality on these cases, briefly summarising, I took the lead of a very complex investigation which was resolved with a settlement in favor of our company. Secondly, another case in which our company was facing challenging charges was successfully resolved before the court in favor of our company. The case was resolved under my leadership which was highly recognised and appreciated by the global team too. As a third example, but not least, I also guided the license team with respect to a patent infringement litigation case where other jurisdictions in addition to Turkey were included too. We achieved to examine the operations in Turkey and stop the infringement in other countries.

What have been the major external trends that have impacted your team’s work over the past two years (market developments, changing regulatory environment, political events etc.)?

Turkey is an emerging country in a transition which has been facing external and internal challenges. After many years of strong growth, Turkish economy is struggling since mid-2018 impacted by internal and external dynamics and 2019 will be a recovery period for another turnaround. Healthcare policy has been key for current government’s 15 years of success with improved access and developed infrastructure. In parallel, Turkish pharmaceutical market has grown significantly by volume while prices are going down resulting in a stable market in dollars. In terms of access, time-to-market is too long and no financing available for new products and indications.

Political and Economic Environment

The Turkish lira (TRY) is highly vulnerable to external and political shocks, reflecting the risks associated with continued large current account deficits predominantly financed through short-term capital inflows, which are subject to sudden reversal in the event of economic or political turbulences.

Cost Containment Measures in the Pharmaceutical Market

The onset of the global recession, and the dramatic increase in healthcare expenditure at a level above that of GDP growth compelled the government to take various measures in each sub-sector of healthcare, which resulted in cost-containment measures for pharma industry.

In pharmaceuticals, the measures were introduced in the following topics:

• International Reference Price System
• Exchange Rate Setting – Fixed Fx rate
• Reimbursement System
• Reimbursement Band
• Various reimbursement restrictions

Pharmaceutical Market Overview

Government’s medium-term development plan (2019-2021) demonstrates that Pharmaceuticals, petrochemicals, energy, machinery and equipment and software sectors are prioritised to decrease current account deficit. Examples include:

• Localisation of 20 biotechnological products
• Increasing number of clinical research centres
• Prioritisation of technology and R&D investments using PPPs

What will be the main focus for the company in the next 12 months and how do you intend to assist with this?

The business priorities of the company for 2020 are; expanding patient access, advocating for value of innovation (clinical research) and securing new launches.

What techniques do you use to provide commercially-focused and optimal business advice to your company? If so, how do you get these across to more junior lawyers in the team?

First of all, I believe it is of the essence for a legal counsel to clearly understand what the business needs. Therefore, I always encourage to work in networks rather than silos for each stakeholder to be aware of everyone’s needs in the team. Additionally, to build such partnerships breaks the barriers between legal and the other team members and enables us to collaborate across the company. I also believe that this “silos” to “networks” model helps us to align the resources, lessen duplication and waste of time.

Other initiatives which enable me and also the stakeholders, including the junior colleagues, to provide commercially-focused advices can also be seen in our new ways of working model which are as follows: (i) from withholding to sharing information; (ii) from controlling to empowering, especially juniors; (iii) from planning to experimentation to test ideas and evaluate what works better; (iv) from knowing to learning to help people to learn from others and think beyond their mindset.

Does the team use any “legal tech” products and do you find them a helpful management device?

We have a special Contract Management system. All contracts executed by any of the stakeholders are being scanned and recorded in this system. Additionally, the system has an automatic warning signal which sends out e-mails to relevant stakeholders to warn them that: “your contract dated … executed with …. will expire on … ”. This is a very helpful tool for everyone to keep track of the agreements with the vendors that they work with.

In addition, we are using SharePoint where we can access any and all documents including but not limited to templates, contracts, useful information, meeting dates, submission deadlines, approved programs. I always ask all of our stakeholders (i.e. team members) to efficiently use this tool to save time and decrease the level of dependence to one individual.

Given that I also have a compliance role besides my legal roles, other than the SharePoint, we have a Compliance Directory App in which everyone can easily download to their mobile phones and access to all SOPs, expense reports, any rules applicable within the company (for example, limits, approved restaurants, hotels), useful information, any information related to our products. This tool enables all of our stakeholders to have an easy access to the main compliance principles and helpful to our company to achieve successful internal audit outcomes.

Further, I lead the bureaucracy task force where I urge people to use digital signature in case accepted by the law to lessen the burden on collecting physical signatures. The digital signature initiative was in place now and, our stakeholders, especially the TMC department (i.e. Travel Meeting Cards), are very thankful for this time-saving initiative.

In what ways do you see the in-house legal role in evolving in your region over the next few years?

Previously, I heard that in-house legal role was more of coordinating the external counsel’s work. However, since I have started my career as an in-house lawyer, I was always involved in both the daily work of the company, as well as the major projects such as contract manufacturing negotiations, litigation cases, meetings with governmental offices. In time, my roles and responsibilities expanded in a way in which I also started to have an active role in management decisions since management team always seeks for a legal input to duly perform their work. Therefore, I really believe that our role as a in-house legal counsel expands every day and the dependence to external counsel are decreasing accordingly. Further, for our region, given that we are operating in a highly regulated industry and the government has a very close eye on pharma sector, I believe the legal role will evolve in a way in which it will be considered as a main function rather than being a support function.

All in all, we need to transform from our position of strength today to enable our companies to become nimbler, more efficient and better positioned to help even more patients in the years ahead.