"Innovation in the pharmaceutical industry is a basic principle and legal & compliance teams cannot be excluded"
Tommy Meneses, legal & compliance coordinator for Chile, Ecuador and Peru at Boehringer Ingelheim, one of the world's leading pharmaceutical companies, tells us about the main tools companies can use to mitigate risk, the innovation instruments that the legal & compliance area uses to streamline its processes and the changes and opportunities generated within the pandemic.
Leaders League: From the compliance area, and given the importance of the sector, what are the main risk-mitigation tools ?
Tommy Meneses: Maintaining a robust internal compliance program is a daily task. Several elements must be considered, such as well-defined internal policies, training for the teams based on the concept of "customer centricity" and a periodic monitoring plan on the different building blocks of the program.
Another essential tool when it comes to mitigating risk is having a properly functioning Compliance Risk Assessment which, in my experience, is more efficient when used in tandem with the business areas that know how processes are managed on a daily basis and can identify the main risks in a more practical way, and then define action plans with responsible parties.
Undoubtedly, one of the greatest challenges is to promote a "Compliance Culture". It is a reality that in the region the implementation of internal compliance programs is something relatively new and still something new generates significant resistance, so it is necessary to work with the teams on the perception of processes and progress checks as tools that allow us to improve as an organization. To achieve this, it is essential to set the tone from the top, that is, to have the support of the executive committee in conveying this message.
What legal innovation tools do you use on a daily basis?
Innovation in the pharmaceutical industry is a basic principle and legal & compliance teams cannot be excluded. We live in a globalized and dynamic world that is rapidly changing, which means that those of us who provide legal services must constantly renew ourselves and work hand-in-hand with technology.
The main tools we use at legal & compliance are: Docusign, a practical electronic signature system that makes life easier for the company's legal representatives and attorneys-in-fact who sign and sign documents of various kinds on a daily basis; Efect, a tool that provides a friendly and automated experience to users when making contracts of various types based on pre-approved forms by the legal & compliance teams in the region, which is linked to Docusign and CorA, which is a tool that works as a repository of contacts and issues alerts in advance when they are about to expire.
It is of utmost importance for the internal compliance program to have a training plan adjusted to the different pillars and audiences in the company. For this, LOS (Learning One Source) contains training materials previously prepared and reviewed by the compliance team that are assigned to users based on an annual training plan and also allows reports generation on the conducted trainings.
What regulatory changes have had the greatest impact on the sector in recent times?
As a consequence of the Covid-19 pandemic, digitalization has marked a before and after in the countries of South America, representing a milestone and an advantage for the pharmaceutical industry since, previously, processes were managed manually and physically. However, now procedures before the authorities have been streamlined and are carried out in a much more efficient way.
Although Covid-19 vaccination programmes have advanced in the region, technical meetings with health authorities are, for the most part, still being held virtually. It is important to highlight the case of Chile, where the Institute of Public Health receives certificates of good manufacturing practices in digital format. This represents an important advance in regulatory processes.
How did you deal with the pandemic? What changes did it bring about for the company?
The pandemic is undoubtedly synonymous with change. One of these changes is teleworking. Although at Boehringer Ingelheim this option was already available before the pandemic, making it permanent was a challenge.
Meetings and conventions that used to be held in person had to be changed to a virtual format, which meant that everyone's schedules ended up being full and we spent long hours in front of the computer. This is why the HR team constantly monitored the situation to gauge how we were coping and also offered psychological, nutritional, financial and legal support to all employees.
What are the challenges for an in-house lawyer today? What aspects do you usually delegate to law firms?
Being an in-house lawyer is extremely interesting, as it involves soaking up the culture of a company, meeting the needs of internal clients and also getting a feel for the key initiatives and projects an organization has.
It is not an easy task, it requires a lot of market research, business priorities and also a practical knowledge of the company's compliance policies, finding a balance between the above elements is key.
External legal advisors can be a strategic ally for the legal teams of the companies, as long as their potential is maximized, since they can provide advice on various impactful issues for an organization which, added to the knowledge of the pharmaceutical industry, the internal policies of the company and the culture, can generate great results.
Regarding the aspects that are delegated to law firms, there is no general rule, there is a wide spectrum, as they can be day-to-day issues (e.g. construction of contracts / templates) or issues of great impact and specialization (e.g. competition, personal data, etc.).
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