Legal manager | AstraZeneca
Semiha Kirişci Elhakan
Legal manager | AstraZeneca
I co-led a Turkey localization project which aimed at manufacturing five AstraZeneca products in Turkey in partnership with two Turkish local manufacturers. As part of my regional responsibilities, I conducted a risk assessment of the company’s distributor markets in the Middle East and Africa, and have updated our distribution management framework.
I am part of AstraZeneca’s Middle East and Africa legal team, and my scope is not limited to Turkey, I am involved in various projects in the Middle East and Africa, and the major trends that have impacted our team’s work are mostly political and social instability across the region. There is also increasing pressure on pricing and reimbursement requirements and a challenging IP enforcement environment.
AstraZeneca will continue to focus on our innovative products while consolidating our existing footprint. We work with different internal and external stakeholders to explore ways to enhance our patients’ access to our products. Legal is proactively involved in the early phases in designing projects aligned with company strategy. We collaborate with each and every stakeholder to understand the business needs and provide legal guidance ensuring alignment with applicable laws and achievement of business goals.
Two important values of AstraZeneca are “we play to win” and “we do the right thing”. The legal department always ensure that AstraZeneca is operating in line with our ethical standards and abiding by applicable laws. At the same time, we adopt a pragmatic commercial approach based on risk versus benefit evaluation. Legal is an integrated part of the commercial structure and we are involved at early stages and provide our inputs at the conception phase. Good understanding of business needs along with deep legal research and risk assessments ensure successful outcomes, and we involve our junior lawyers in these processes and projects to effectively support their professional development.
We use electronic signatures, contract and document management systems, automated contract tools and approval workflows within the legal department. AstraZeneca has also a global interest in exploring AI. Personally, I find legal tech to be a helpful management device. These technologies provide effective document management, secured information sharing platforms and effective archiving. They also enable us to allocate our time where we focus on important legal matters allowing maximum output with minimum resource.
The importance of in-house legal counsel is significantly increasing, and now we see more companies hiring general counsels in their senior management teams. The role of legal is evolving from an enabling function to a key collaborative partner influencing the organisation’s commercial strategy. Early legal and compliance risk assessments with a pragmatic approach is crucial for the success of company goals. We are determined to deliver value, focussing on business-critical risks in a changing environment.
The evolving function of legal under a data privacy framework
The pharmaceutical industry and in particular AstraZeneca is empowered by science, research and development. Remarkably the digital strategy and innovation teams are changing and improving the foundations of our relationship with patients, project teams, brands and health care providers, through the use of innovative digital technologies. Medical technology sales were US$363.8bn in 2013 and are projected to reach US$513.5bn in 2020. In parallel, the legal environment and regulation require fast adaptation to technological and scientific developments. Technology such as AI/machine learning, “Big Data”, mobile apps, social media, cloud computing, next generation sequencing and smart medical devices are growing rapidly. In this respect, data privacy is one of the fields that has gained prominence across legal and business practices.
Firstly, legal professionals need to shape a trusted data processing framework and support the development of such a culture within organisations and society. To lead this change, it is vital for companies to secure and maintain the trust of people, whose data is processed in order to deliver these innovative and technological solutions aimed at providing better health care solutions and improve their quality of life. For instance, privacy notices, sometimes also referred to as a fair processing notice, as defined under EU General Data Privacy Regulation is the public document from an organisation that explains how that organisation processes personal data and how it applies data protection principles. Therefore, privacy notices, as required by law, must be concise, transparent, understandable and available for easy access. Legal professionals should find the right balance between using legal jargon required by applicable data privacy laws to protect the data controller’s exposure, whilst also ensuring that such notices are written in plain language that is clear is enough to be understood by any and all data subjects.
To facilitate, embed and shape a culture of trust, it is crucial that legal professionals change their pre-existing conventional and siloed approach, and are required more than ever to think “out of the box”. We need to be agile, ready for change, prepared to find alternative solutions, and we need to have the ability to develop new competences, and have a creative mind set in order to adopt to everchanging data sharing environment.
Additionally, it is essential that all relevant parties, sector associations, non-governmental organisations and patient support organisations take part and provide insight and opinions not only in the pre-enactment of the laws and secondary legislations, but in the entire process of implementation for shaping the trusted data sharing environment and supporting scientific and technological rapid change for the benefit of patients and healthcare. I believe data privacy authorities also play a crucial role, especially on setting forth sector specific resolutions on data privacy matters. Data Privacy Authorities’ proceedings and principle decisions are important on guiding the companies to shape their data privacy harmonisation projects within their organisations.
We play an important role serving as a bridge between people having access to technology improving quality of people’s life within a framework established only on lawful, ethical and transparent grounds. In the era of information technology, a competent legal will understand and embrace the science, so that we can shape our legal environment as fast to be able to adopt to the new world.