Whitepaper: Together Beyond COVID-19 A Look at the Future

Introduction The year 2020 has been challenging. COVID-19 struck, causing a global crisis, and people worldwide were forced to adapt to the new normal brought on by the pandemic. The current situation has affected industries differently, benefiting some and disrupting, even sidelining, others.

In a short time, COVID-19 has increased our dependency on technology. Companies are actively investigating the role of digital transformation. In developing digital strategies, the focus must be on increasing efficiency while minimising risk. When adopting new technologies, it is important to have a clear strategy in place. This process will require more efforts in terms of change of management skills because, at its core, digital transformation is all about people. It requires the system composed of people and technology to be well organised and aligned for the future. Consequently, COVID-19 has been a catalyst for innovation and digital transformation.

To understand the challenges that the pharmaceutical industry faces during COVID-19, open-ended interviews were conducted with top pharmaceutical companies around Europe. The methodology followed during the interviews was semirestrictive, using a general outline of questions that led to other topics based on the spontaneous response of the interviewees, but always in relation to the general topic: COVID-19 and digital transformation. Some of the companies interviewed were Roche, AstraZeneca, Cinfa, Neuraxpharm, Amryt Pharma, Almirall, Alcala Pharma, and Dompé, amongst several other pharmaceutical companies. As a result of the interviews, meaningful qualitative data was collected. This paper summarises the main highlights, together with the future vision. Digital Tools and Data Analytics Digitalisation is causing upheaval. Since COVID-19 hit, companies have been forced to upgrade their systems and learn how to facilitate employees working from home. This change, which was projected to occur in the next 5-10 years, has happened over a matter of months. During this pandemic, the use of digital health has become more popular amongst physicians as many patients do not feel as safe going to doctor appointments in person as they did before COVID-19. In addition, virtual medicine has been crucial in reducing the spread of the virus and the pressure on emergency rooms. Before COVID-19, the percentage of patients using remote consultation was very low (only 6%). However, digital health has gained momentum, and at least 19% of consultations are expected to continue remotely after the pandemic subsides (Source: Statista).

Pharmaceutical companies have also considered digitalisation as an opportunity to improve their business models. It provides a new potential stakeholder journey that enables them to communicate directly with clients. During the pandemic, many pharmaceutical companies have strengthened their efforts by offering patients and physicians information via digital communications, remote clinical monitoring, and video consultations. As an example, one of the pharmaceutical companies interviewed created a digital package for physicians and patients including a Q&A with relevant information about how to manage the new COVID-19 situation. This new way of engaging with the different stakeholders requires constant marketing efforts to differentiate from competitors.

Digital analytics is another key component of digitalisation. Artificial intelligence and data analytics are crucial to defending against future public health crises. Data analytics could help companies more accurately predict supply chain disruptions and forecast demand to avoid potential drug shortages. Surprisingly, of the pharmaceutical companies interviewed, none experienced any critical disruption in their supply chain, thanks to accurate forecasting. Using big data in healthcare can provide a 360-degree view of physician, patient, and consumer trends, which will help improve personalisation and efficiency of treatments within organisations. COVID-19 has emphasised the importance of translating data into a digital format for the creation of global databases. These databases store large amounts of data to help scientists and physicians increase understanding of both medications and patients in order to promote innovation. This infrastructure will facilitate open collaborations within the industry that lead to better outcomes.

An essential piece of the puzzle for many of the pharmaceutical companies interviewed is the implementation of a digital tracking system to follow up treatments and create the history of each patient to predict future treatment trends. These trends could, for example, help predict recurrence of symptoms. The use of data can help track high-risk patients, show trends and patterns of the disease, or even track the hospital capacity in a specific territory. Big data facilitates the restructuring of the healthcare industry. Various electronic tools are being used in companies to identify and inform physicians about patients who need specific therapies. These cases are discovered through the analysis of trends. Along with patient information, global databases can function as product registries. With access to digital information, doctors would be able to access patients’ medical records from anywhere in the world to provide the right prescriptions and care.

Digital health and big data solutions raise some ethical issues, mainly related to the confidentiality of personal information. As mentioned in one of the interviews, there are some significant aspects that should be taken into consideration, such as the fear stakeholders might feel towards the technological side of things. A key point to consider when using these tracking systems and data is the need for patients to grant approval for the use of their personal information.

Moreover, patients and physicians are still concerned about the quality of medical services provided electronically. In routine care, digital health is most useful for patients who have chronic conditions or who utilise psychotherapy as a part of behavioural healthcare. Both areas have been important during the pandemic. The classification of

patients and specialities is key to increasing the efficiency of digital health, which would normally be focused on primary care and pre- and post-surgical visits. Digitisation Towards Sales and Marketing Pharmaceutical companies have had difficulties attracting specific target audiences during COVID-19. It remains unclear how relationships will be built between pharmaceutical companies and different stakeholders such as physicians and patients. These sudden societal lockdowns and restrictions are driving new, meaningful ways of building personal connection through digital interactions. COVID-19 has forced pharmaceutical companies to implement reactive, rather than proactive, commercial strategies focused on the crisis and short-term solutions. In the long term, pharmaceutical companies must tailor their marketing strategies with new appealing commercial models. They must adapt and help their employees maintain relationships while building new ones with the same level of quality and engagement. Communication should be detailed, concise, and frequent. Companies must add value to demonstrate why they are the best option. As the strategy changes to be more patientcentric, companies will need to add more communication-specific roles, encourage digital marketing, have employees focused on e-learning, and much more. Sales representatives must be persuasive online to keep physicians’ attention while contacting them remotely.

Pharmaceutical companies have also reacted quickly to digitalising marketing promotional materials in order to engage clients. Both physicians and patients have been overwhelmed with content from multiple sources. Therefore, the management of an efficient content development strategy has been critical for commercial success. Companies have been focusing on sending multiple, varied messages which included only short, critical pieces of information. Some of the interviewees have also used the COVID-19 pandemic as an opportunity to improve their marketing strategies in the long term by building an omnichannel experience to engage with patients and physicians. As discussed during one of the interviews, companies should reconsider how to provide an integrated experience that includes a mix of channels with the right content and a personalised approach to communicate with the client. To make the experience more engaging, each client should be contacted through their preferred platform and sent both personalised and branded documents. The creation of an omnichannel strategy permits pharmaceutical companies to be flexible and prepared for any change in customers’ behaviour or requests. Organisations will need to facilitate an agile decision-making process to adapt quickly to each audience and to tailor the content to their needs.

Some pharmaceutical companies have explored the use of free messaging apps during COVID-19 to exchange information amongst users. These tools have proven to be a great channel. They facilitate the interactions between healthcare professionals and patients while maintaining personal interaction. However, security and data protection policies must be considered. To offer a customised solution for healthcare professionals, specific systems with additional security and privacy standards are required as an alternative to free apps.

Additionally, it is important to properly track customer engagement to measure the effectiveness of different marketing initiatives. Analytics should be used and the right key performance indicators (KPIs) established. Engagement could be easily tracked by integrating the platforms used for communication between patients and physicians with customer relationship management (CRM) systems. New Ways of Operating for Clinical Trials and Specific Therapies COVID-19 has initiated new ways of carrying out clinical trials safely and effectively. Ongoing clinical trials with recruited patients continue, but recruiting new patients presents a challenge. Increased exposure to COVID-19 during recruitment has caused significant delays in trials. Moreover, highrisk patients are reluctant to go to hospitals to get the necessary treatment.

To overcome this situation, some pharmaceutical companies interviewed used electronic tools and additional remote medical options in homes to monitor progress. Remote clinical trials allow patients to participate without barriers such as COVID-19 exposure or mobility limitations.

These services also benefit patients for treatments outside of clinical trials. Companies have started delivering treatment products to patients’ homes. In addition, nursing care has been provided at home for specific therapies in order to conduct the necessary physical examinations and to supply the appropriate medications. These new services maintain the special care provided by nurses at the hospital. They also allow pharmaceutical companies to be in direct contact with patients and to explore innovative potential stakeholder journeys. For instance, nursing care can be a valueadded service separate from the product. Individual monitoring and analysis of the data can anticipate future health problems to put the right preventive measures in place. Another way to combat the barriers of COVID-19 is to ship treatments directly to patients. This allows delivery routes to be both simplified and shortened. As a result, the supply chain carries fewer risks, and this new distribution model reduces cost and time.

As additional services are included in the stakeholder journey, the pricing strategy and potential tax implications will be affected. For instance, regulators do not consider the services or the accompanying devices when pricing a medicine, which leads to significant debate about reimbursement. To correctly adjust pricing, regulations regarding price reimbursement must be changed to prove the cost-benefit value of this service to the client. Standard measurements must be considered, such as efficiency, security, and cost-benefit analysis. During one of the interviews, it was discussed how, in order to drive long-term competitiveness and sustainability, companies will need to either focus on price or improve the overall safety of the patients by efficiently delivering home services. It is imperative that pharmaceutical companies have open conversations with authorities in order to implement these new stakeholder journeys with the appropriate restructured reimbursement policies. 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 teambuilding 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 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 any more, 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 increases 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 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 resources 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, guaranteeing 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 PharmaLex 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, PharmaLex.

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

Jacobo de Silva Urquijo

Supply Chain and Operations Partner, EY