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The New Digital Era for Regulatory Affairs and Compliance

Regulatory authorities have been flexible about many processes during this emergency period. They have accepted document formats that would not have been considered under normal conditions. Authorities have agreed to facilitate marketing authorisations, mainly for medicines and medical devices that are considered crucial during the pandemic. Acceptable documentation in alternative formats has prompted regulators to establish new processes for review. Agencies now review dossiers more quickly than before without sacrificing quality, safety, or the efficacy of the information. The interviewed pharmaceutical companies are very satisfied with the measures taken by the authorities and consider these new ways of working to be efficient. Consequently, authorities should consider keeping these procedures in the future and establishing similar measures with the same flexibility for all marketing authorisations including other drugs and medical devices.

During the pandemic, most of the companies interviewed have felt the support of the authorities more than ever. Companies have been able to contact regulators, especially in emergencies, to get advice on reducing problems with supply chain, safety, regulatory issues, and much more. The support and flexibility from the authorities have reduced time and costs. As a result of this agile approach from the regulators, pharmaceutical companies are wondering how this collaboration will continue post-Covid-19. They feel that Covid-19 has brought an opportunity to enhance these relationships and establish new ways of working and developing new procedures. Round tables with the involvement of the pharmaceutical leaders and regulatory authorities together with the support of external consultants could facilitate alignment and agreement to bring innovative solutions that benefit all stakeholders.

One of the companies interviewed highlighted the need for open discussions with the authorities about advancing digital technologies. New formalised health information for patients could be created through websites with approved technical content from the health authorities. This approach would facilitate compliance, provide patients and physicians with reliable information about products and services, and allow information to be accessed from anywhere.

Another consequence of Covid-19 is the use of alternative methods to approve documents that previously required wet ink signatures in the pharmaceutical industry. To validate protocols and reports, risk assessments, technical reports, or signing documents often meant ink on paper, including printing and scanning, to be able to send the signed document by email. During Covid-19, many organisations interviewed mentioned that their processes for approving paper documents with wet ink signature are no longer achievable and have been replaced by e-signatures. Authorities have been understanding regarding this new situation, and many have eased restrictions while maintaining control to avoid potential risks.

An electronic signature is generally permitted; however, for the signature to be valid, it needs to be unique and linked only to the signatory. In addition, the method used to sign must be reliable. Depending on the nature of the transaction, the use of the electronic signature could have additional requirements. Therefore, it would be beneficial to design an electronic system for controlling certain sensitive transactions. Further considerations to increase control are the implementation of workflows within the organisation for the review and approval of the electronic documentation.

Human Resources to Support the Move towards Digitisation

The human resources (HR) department of every organisation plays an important role in supporting business continuity during Covid-19. Working remotely is a potential new normal with a new mindset that needs to be driven by HR. One of the most challenging things HR has had to manage is helping employees balance their work and life in the new situation. Companies quickly pulled together workshops to educate employees on good practices such as stress management. Webinars and online team-building activities have also been carried out during the pandemic to keep employees engaged. Compared with 2019, participation in webinars has increased by 60 %. Most companies interviewed mentioned that efficiency and productivity have increased during the pandemic, as many employees are working during time previously used for commuting.

One of the challenges that the management is facing is keeping employees engaged, efficient, and satisfied with this new style of working in order to keep high productivity levels. One of the companies interviewed mentioned that timetables of the employees during Covid-19 are not controlled anymore, and they mainly focus on the end results that are achieved. The acceptance level of more open schedules has given employees more freedom to manage and balance their personal and working lives more adequately and contributed to achieve the expected efficiency levels and even higher. Although efficiency and productivity have not decreased, it will be important to continue monitoring the effectiveness of remote working to evaluate the future of ‘working from home’ beyond the pandemic.

Establishing the right KPIs is crucial to keep track of employees’ performance while working from home. Some of the interviewees have implemented ways to check-in and check-out for monitoring where employees are located and when they are available. This technique facilitates effective communication between employees, as timetables are different for some personnel due to family obligations. Constant communication is critical to engage with employees, to ensure knowledge sharing across the organisation, and to make employees feel supported and valued within the company. With the implementation of KPIs, a well-planned incentive programme, and strong company policies, employees feel motivated and grateful, which increase their productivity levels. It is also vital for HR to closely monitor employment policies and benefits and more importantly, working practices. HR will also need to keep abreast of the latest changes in local employment laws, which may be adjusted to account for the new work environment.

Conclusion

Before the pandemic, digital transformation was a long-term goal within the pharmaceutical industry. Now it is a necessity that comprises of having open and more meaningful interactions with authorities, patients, doctors, and colleagues within our own organisations. The companies interviewed perceived Covid-19 as an opportunity to accelerate their digitalisation plans both externally and internally.

Externally, the Go-to-Market strategy is evolving towards new potential stakeholder journeys that are patient-centric. They lead to the use and creation of digital tools and care services that aim to connect people within and across our healthcare systems. The new stakeholder journeys require additional marketing efforts to create omnichannel strategies, which also contain secured online platforms for the rapid and personalised exchange of information with selective content. The use of digital health during the pandemic has been encouraged amongst physicians and their patients to maintain contact. If used correctly, a combination of data analytics and digital health could achieve universal health coverage at a cost-effective rate, preventing many diseases and saving many lives.

As a result of Covid-19, new emerging healthcare journeys are becoming more relevant to explore and demonstrate the need for honest conversations with the authorities and the health community regarding the potential impact on public policies. Additionally, the regulatory authorities have been flexible and have implemented efficient procedures for pharmaceutical companies. This agility shows that there is room for change and digitalisation beyond the pandemic.

Internally, every company’s human resource department plays an important role in accommodating employees in their new working environment. HR should develop the right programmes to enable employees and help them master the new situation, guarantying the least amount of impact to their lives. Accordingly, HR and management should continue working on business continuity plans while exploring future new ways of working. Plans should emphasise the use of an agile change management approach with special focus on delivering a consistent communication strategy that makes employees feel involved and supported.

Adaptations by organisations to the circumstances surrounding Covid-19 have demonstrated that there are always solutions when there is a need. The future challenge to this new digitalisation era is to ensure that what has been advanced will remain once the Covid-19 limitations are lifted. EY and Pharma Lex will be delighted to support the pharmaceutical companies to continue advancing towards the future designing and implementing the right strategies and tools to achieve their objectives.

* Marta Vila Ramos, VP Corporate Development, Business Strategy and Innovation, Pharma Lex; Baltasar Lobato Beleiro, Health & Life Science Partner, EY; Manuel Gonzalez Fernandez, Managing Partner of Finance Transformation, EY; Miguel Gallo Martinez, Lead Partner of Business Design, EY; and Jacobo de Silva Urquijo, Supply Chain and Operations Partner, EY

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