Affordable, fair, and timely access to effective medical and healthcare solutions is a critical pillar for the Life Sciences sector, with significant societal impact potential. The question of how to strategically improve access to these solutions includes considering the full range of end-users in the design of products, ensuring diverse and inclusive clinical trial data sets11 during the development phase, and facilitating fair and equal distribution in traditionally un(der)served communities, as well as higher socio-economic segments of society. While the scope of access was once narrowed to availability and price, the scope of what it means in current society is widening. Access includes literacy (access to information, including scientific articles), access to the diagnosis (not only the solution), and access to solutions that are made for specific demographics, to name a few considerations. The broadening scope of access represents a key business opportunity for Life Sciences and the expectations of stakeholders are rapidly changing.
Access to quality healthcare and life-saving treatments is a fundamental Human Right. Yet, according to the latest monitoring report by the World Health Organization and World Bank Group,12 approximately 4.5bn people (>55% of the global population in 2021) have limited or no access to healthcare or medication, and one in 10 drugs sold in developing countries is fake or substandard,13 leading to hundreds of thousands of deaths every year.
With the global population projected to increase to around 8.5bn people by 2030,14 and the greatest increases in low- and middle-income countries (LMICs), there is huge opportunity for Life Sciences companies to ensure access to health services and medical treatments through the development of partnerships that contribute to more integrated business and service ecosystems. This would also provide clear social benefits by improving healthcare outcomes for LMIC communities.
11 KPMG. (2022). Diversity, Equity, and Inclusion in Clinical Research. Retrieved from: https://assets.kpmg.com/content/dam/kpmg/be/ pdf/2022/LifeSciences-DiversityEquityInclusion-ClinicalResearch.pdf12 World Health Organization & International Bank for Reconstruction and Development / The World Bank. (2023). Tracking universal health coverage: 2023 global monitoring report [Report]. Retrieved from: https://iris.who.int/bitstream/handle/10665/374059/9789240080379-eng.pdf
Within these ecosystems, companies can reap significant gains from developing strategic partnerships and collaborating more closely on projects of mutual interest. Doing so enables companies from these segments to be better aligned with healthcare providers and end-users, supplying them with the complementary products and services they need. At the same time, this also helps companies to spread their risk and improve their efficiency by avoiding duplication of work and resources, which can improve profit margins.
Areas that offer potential for new partnership development include patent licensing; equity acquisition; non-equity alliances; joint ventures; R&D collaboration; and commercialization. For example, developing partnerships around non-exclusive voluntary licensing (NEVL) to allow generic manufacturers to supply patented products to communities that struggle to access the medicines and medical devices they need is a highly effective way for pharmaceutical and medical device companies to better serve LMIC communities.15
13 World Health Organization: WHO. (2017, November 28). 1 in 10 medical products in developing countries is substandard or falsified. World Health Organization. Retrieved from: https://www.who.int/news/ item/28-11-2017-1-in-10-medical-products-in-developing-countries-is-substandard-or-falsified14 United Nations. (n.d.). Population | United Nations. Retrieved from: https://www.un.org/en/global-issues/population#:~:text=The%20 world%20population%20is%20projected,and%2010.4%20billion%20by%202100.15 Access to Medicine Foundation. (2022). Access to Medicine Index 2022. Retrieved from: https://accesstomedicinefoundation.org/ medialibrary/2022_access-to-medicine-index-1669982501.pdf
Risk consideration;
Clearly defined partnership scope;
Detailed partnership agreements;
Auditing technologies and competencies;
Exit strategy;
Conducting regular and purposeful business assessments by defining milestones that can be measured reliably as stop-and-go decision points; and
Demonstrable evidence of impact.
Yes, we are currently engaged in multiple partnerships.
Yes, we are exploring potential partnerships.
Not currently, but we plan to in the future.
No, we are not seeking partnerships at this time.
Unsure or undecided.
“At Bayer, we have a clear expectation that our social impact approach to access to medicine will generate sales and turnover, while also serving society. Maybe at a different speed with a slightly diluted margin, but we expect to generate business, so we are investing both financially and in developing effective relationships with our partners across the globe accordingly.
Wherever you try to develop new business approaches to provide better access to medicine, I haven’t seen one where it works without partnerships. Shifting from traditional core businesses to enter new spaces is a complex process, so finding the right partners with local understanding is vital to ensuring a successful outcome. This is especially the case in low- and middle-income countries, where you may need to re-design your business to adapt it to the local operating environment.
For example, one of Bayer’s key social impact targets is to help 100 million women around the world access contraception by 2030. Women in different countries face different challenges in this regard, so the way we organize our access to contraception program is always in local partnerships. We run our access to contraception program as a social business model, and while we do not yet always achieve the same margins that we used to with a traditional approach, we re-invest the money that we do make into that same business to help it thrive so that we can achieve our 2030 goal.
We have also recently opened a Global Health Unit, where we try to access countries where we don’t currently have representation - typically developing countries, including many in Africa. Again, if we don’t have direct business representation, we can only work through partnerships, which further underlines just how important good partners are to delivering results for both our businesses and society.”
Klaus Kunz Vice-President, Head of ESG/External Engagement and Performance Reporting16 Bayer
16 Dr. Kunz kindly provided input to this publication in 2023, during his tenure at Bayer (July 2001 – March 2024).
Innovation in Life Sciences lies at the intersection of social and environmental sustainability. Not only can it support socio-economic improvements, but it is also key to finding solutions to emerging diseases caused by climate change and keeping up with demographic changes that need new solutions for new problems. However, the impact is highly dependent on the extent to which scientific innovation is actively dispersed through the economy, whether through new business lines, partnerships, public procurement, or philanthropy.
Many Life Sciences companies cite contributing to the third UN Sustainable Development Goal17 - which aims to achieve universal health coverage and the provision of safe and affordable medicines and vaccines for all - as relevant to their businesses in their corporate sustainability messaging. This should naturally extend to striving to ensure equitable access to their innovations, particularly for vulnerable populations and un(der)served regions. However, it doesn‘t mean that Life Sciences companies need to be alone in working on this. Balancing intellectual property rights with broader Human Rights to benefit from scientific progress is a nuanced challenge.
Life Sciences entities should explore mechanisms that promote open access to knowledge and innovation while maintaining incentives for research and development. Collaborative initiatives and licensing arrangements may help in striking this balance, as well as exploring possibilities to leverage patent expirations, reorienting them from a business risk to an opportunity by providing a service that educates partners or patients on these products. This could take the form of a business line (training and education) and/or be part of a wider philanthropic program, which supports the company’s reputation as a leader and a force for social good.
Meanwhile, joint efforts between governments, industry, and civil society are also needed to promote the realization of the universal right to healthcare, and discriminatory practices that hinder access based on socio-economic factors must be eliminated.
Scientific innovation makes it possible to serve a broader patient base with ever-more diverse needs, which is not only good for society, but presents clear economic opportunities for business expansion. For example, in many countries the population demographics are shifting such that the percentage of the population that is elderly is growing. This implies a higher burden of non-communicable diseases, with a corresponding opportunity for business expansion in non-communicable
17 United Nations Development Program: UNDP. (n.d.). Sustainable development goals. United Nations. Retrieved from: https://www.undp. org/sustainable-development-goals
therapies and contributions in consortia to fight new age-related diseases.
Innovative technologies also enable Life Sciences companies to react more quickly to new opportunities and better serve evolving patient needs, some of which may only affect small numbers of the population but may nonetheless be vital to those patients’ care and recovery. This includes examples such as ‘technology that makes it possible to manufacture cell and gene therapy for an individual patient’18 or working with specific demographics, using a patient engagement approach to help design, develop, and distribute appropriate products and therapies that account for the patients’ experiences, needs, and preferences.
Human Rights considerations are central to ethical research and clinical trials. Informed consent, privacy, and the protection of vulnerable groups are paramount. The World Medical Association’s (WMA) Declaration of Helsinki19 and the Good Clinical Practice (GCP) guidelines20 underscore the importance of respecting participants' autonomy and rights. Life Sciences entities must conduct rigorous ethical assessments to prevent exploitation and uphold the dignity of research subjects.
Ensuring treatment-patient fit is critical to successful patient outcomes for the Life Sciences and healthcare sectors alike.
This starts from the development phase of a new drug or medical device, ensuring that the test subject populations in clinical trials are representative of the diversity of society, especially in terms of sex, ethnicity, and age. Historically, clinical trial subjects have been disproportionately male and in the 18-35 age group.
There may be risks and benefits associated with medical solutions that do not apply to this demographic, and therefore may make the treatment either less suitable for other patients or result in missed opportunities to provide more effective treatment – especially where one demographic may respond better than another to a particular treatment.21
Getting the right diagnosis and treatment is intrinsically linked with how clinical trials are set up and conducted. Not only that, but vulnerable patients need to be confident that the diagnosis and treatment that they receive is the right fit for them. Building trust with these patient communities and developing treatments that are more effective for them will be the foundation for significant business expansion in the future.
18 SAP. (2022). The Transformation Mindset: How Growing Life Sciences Companies Scale Profitably and Sustainably. Retrieved from: https:// www.sap.com/cmp/dg/transformation-mindset-life-sciences/typ.html?pdf-asset=a24ce33c-317e-0010-bca6-c68f7e60039b&page=119 The World Medical Association: WMA. (n.d.). WMA Declaration of Helsinki – Ethical principles for medical research involving human subjects. Retrieved from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
20 European Medicines Agency. (2022). Good clinical practice | European Medicines Agency. Retrieved from: https://www.ema.europa.eu/en/ human-regulatory-overview/research-and-development/compliance-research-and-development/good-clinical-practice21 KPMG. (2022). Diversity, Equity, and Inclusion in Clinical Research. Retrieved from: https://assets.kpmg.com/content/dam/kpmg/be/ pdf/2022/LifeSciences-DiversityEquityInclusion-ClinicalResearch.pdf
“Patient engagement is meaningfully and systematically partnering for the long term with patients, their caregivers, patient advocates, and patient organization representatives to deliver better outcomes. Throughout the innovation life cycle, we implement a framework that ensures continuous dialogue with the patient community to understand their needs, preferences, and priorities to inform our decision-making, co-create solutions, and empower their voices.
Patient engagement is a key driver of our Patient Value Strategy - UCB’s corporate strategy. Among our flagship projects is direct patient input at our Benefit-Risk Board (BRB), UCB’s highest governance body addressing benefit and risk topics. Selected patient-experts with benefit-risk assessment experience are on the BRB as non-voting members; they provide input to inform our decision-making but are not responsible for the BRB’s decisions.
We also co-established a strategic council - a best practice for partnership with patient communities - with the major patient organizations for a particular disease to resolve key research problems, from diversity in clinical trials to interactions with regulatory bodies. For example, during an early-stage clinical study for a medicine under investigation, we discovered an unexpected adverse reaction. Through the council’s patient groups, UCB was able to quickly gain feedback from patients with the same profile as those in the study, to understand whether the medicine’s benefits outweighed the reaction risk. Instead of a resource-intensive patient preference study, the patients’ direct and timely input helped our team to confidently continue the research.
Patient engagement delivers better outcomes by addressing what matters most to patients. Alongside social benefits, this improves resource efficiency and sustainability in the product life cycle. By involving patients, we can focus our efforts on developing products and solutions that closely meet patients’ priorities and bring effective treatment to market as quickly as possible.”
Alexandra Moutet Global Head of Patient Engagement UCB
