Professional Documents
Culture Documents
Tagore Sharma
Tagore Sharma
Please use the table below as your cover sheet for the 1st page of the submission. The sheet should
be before the cover/title page of your submission.
MSc Management
Business Project
Module name
Schedule Term
Report/Assignment Title
Date of Submission
(Please attach the confirmation of
any extension received)
I hereby declare that I have read and understood BPP’s regulations on plagiarism and that this is
my original work, researched, undertaken, completed and submitted in accordance with the
requirements of BPP School of Business and Technology.
The word count, excluding contents table, bibliography and appendices, is words.
By submitting this coursework you agree to all rules and regulations of BPP regarding assessments
and awards for programmes. Please note, submission is your declaration you are fit to sit.
BPP University reserves the right to use all submitted work for educational purposes and may
request that work be published for a wider audience.
Table of Contents
1 Executive Summary:................................................................................................................4
2 Introduction..............................................................................................................................5
2.1 Challenges and problems:.................................................................................................6
2.2 Healthcare Innovation in Light of Current Trends:..........................................................7
2.3 Problems with Pharmaceutical Research, Healthcare Costs, and Patient Access:............8
3 Impact of Research on Stakeholders:......................................................................................8
3.1 Internal Stakeholders:.......................................................................................................8
3.2 External Stakeholders:......................................................................................................9
3.3 Stakeholder Intensity Map:.............................................................................................10
3.4 Summary of stakeholders:...............................................................................................10
4 Evaluation and Analysis with Secondary Data for the Purpose of the Report......................11
4.1 Porter 5 forces analysis:..................................................................................................11
4.2 PESTLE Analysis:..........................................................................................................13
4.3 Comparative models analysis:........................................................................................16
5 Recommendations and Conclusions......................................................................................17
5.1 Recommendations based on the evaluation and analysis:..............................................17
5.2 Conclusion Summarizing the report:..............................................................................19
6 References:............................................................................................................................21
List of figures:
Figure 1: Pricing and Market Access (Gittfried et al., 2020)..........................................................6
Figure 2: Biotechnology and Advanced Therapies (Dahir, Cinotti and Feirsen, 2019)..................7
Figure 3: Porter 5 forces analysis (Koçkaya and Wertheimer, 2018)............................................11
Figure 4: PESTLE Analysis (Sendyona, Odeyemi and Maman, 2023)........................................13
4
1 Executive Summary:
This consultancy report summarizes the pharmaceutical industry is a growing and vital industry
that helps people all over the world get access to potentially life-saving medicines. The
international pharmaceutical corporation GlaxoSmithKline (GSK) faces a wide range of
difficulties in its home country of the United Kingdom. This consulting report zeroes in on one
of GSK's biggest headaches: the price and availability of pharmaceuticals in the British market.
This paper provides a thorough analysis of the challenges at hand and offers recommendations
for effective navigation as GSK strives to strike a balance between profitability, patient access,
and compliance with growing laws.
Government rules and policies have a significant impact on the pharmaceutical industry.
Changes in government leadership or healthcare policy can have a major impact on medicine
pricing and market access, both of which are crucial to GSK's business. Pharmaceutical
companies like GSK need to take into account the socio-economic disparities in the UK as the
healthcare system shifts to a patient-centric model. GSK should keep spending money on R&D
so that it can stay ahead of the competition and keep up with shifting healthcare preferences.
Research that focuses on customized medicine and digital health solutions, for example, has the
potential to yield novel treatments that find favor with both patients and healthcare systems.
Given the UK's socioeconomic divide, GSK would be well to devise market access methods that
can flex to meet changing conditions. This includes making sure products are available to all
demographics of the population and taking into account the cost of pharmaceuticals for patients
from all socioeconomic backgrounds when designing access initiatives. GSK needs to be on the
lookout for regulatory shifts because of the weight that politics carries in setting drug prices. This
includes adjusting to the new rules and regulations that will be implemented in the UK as a result
of Brexit. To maintain compliance and limit price and market access fluctuations, businesses
must be proactive in responding to regulatory changes. GSK needs to keep showing its
dedication to sustainability and corporate responsibility if it wants to improve its reputation and
live up to rising environmental and societal standards. Market entry may be improved if this
conforms to the expectations of customers and authorities.
5
GSK may get important insights into patient demands and product efficacy by adopting
advanced data analytics and implementing data-driven decision-making into pricing and market
access initiatives. Data-driven pricing techniques have the potential to be more accurate and
specific. In sum, GSK has a complex problem with drug pricing and market access in the UK,
which is affected by a wide range of internal and external variables. There must be a careful
balancing act between innovation, compliance, collaboration, and a focus on the patient if this
problem is to be overcome. GSK can maintain its leadership position in the pharmaceutical
industry, providing meaningful benefits to patients while maintaining its financial viability, by
following the advice offered in this paper.
2 Introduction
GSK is a well-known pharmaceutical and healthcare conglomerate with strong roots in the
United Kingdom. This paper seeks to examine and assess the problems faced by pharmaceutical
industry leader GSK in order to better inform strategic decision-making. The pharmaceutical
sector faces complex and ever-evolving regulatory constraints. Keeping up with UK regulations
that affect medicine clearance, marketing, and distribution is difficult for GSK. It's crucial to
keep everything running smoothly, economically, and in accordance with certain rules.
Pharmaceutical product pricing and reimbursement in the United Kingdom (UK) have become
increasingly complex in recent years. GSK must strike a balance between protecting the
profitability of its therapeutic portfolio and providing patients with access to life-saving
treatments. GSK's business model is threatened by price competition and barriers to entry in key
markets (Johansson et al., 2019). A pharmaceutical firm must always be on the cutting edge of
medical innovation. Although GSK is committed to meeting changing healthcare requirements
with creative new treatments, the company confronts obstacles in doing so. It's not easy to
balance the need to invest in R&D to generate breakthrough medicines with the requirement to
keep costs and risks under control.
The purpose of this study is to give GSK in the UK a thorough analysis of the problems that have
been identified, as well as their consequences and suggestions for moving forward. The study is
broken down into several sections: an introduction to the problems GSK is facing, the report's
rationale, an analysis of the impact on stakeholders, a critical evaluation of the concerns based on
secondary evidence, and finally, solutions. Readers can anticipate learning about the difficulties
6
GSK is having in the UK market, how those difficulties may affect various stakeholders, and
what might be done to assist GSK in overcoming those difficulties. This research aims to help
GSK adjust to the ever-changing pharmaceutical industry by facilitating regulatory compliance,
expanding access to the market, and stimulating innovation in healthcare solution delivery.
Drug Pricing and Market Access: The intricate drug pricing and market access system in the
UK is another major obstacle for GSK. Both the NHS and NICE (National Institute for Health
and Care Excellence) play critical roles in regulating how much pharmaceuticals cost and where
they can be purchased (Gittfried et al., 2020). Governments, lobbying organizations, and payers
all exert price pressures that make this an uphill battle. The success of GSK's UK business
depends on striking this balance.
Innovation and Research: Innovation is essential in the healthcare sector because of its rapid
rate of change. Keeping up with these developments and anticipating future healthcare
requirements presents substantial challenges for GSK. Novel and more effective medicines
require significant investment of time and resources (Dahir, Cinotti and Feirsen, 2019). Although
advances in these areas have the potential to radically alter treatment paradigms, doing so will
necessitate significant new funding for R&D and the incorporation of cutting-edge technologies
into the drug discovery and development process.
Biotechnology and Advanced Therapies: Biologics, cell treatments, and gene therapies are
revolutionizing healthcare thanks to advances in biotechnology. It will be difficult for GSK to
break into these emerging therapeutic areas without the proper resources, connections, and
knowledge (Dahir, Cinotti and Feirsen, 2019).
Figure 2: Biotechnology and Advanced Therapies (Dahir, Cinotti and Feirsen, 2019)
Digital Health and Data-Driven Solutions: Changes in healthcare delivery brought about by
digital health technology such as telemedicine, wearables, and health data analytics. When it
8
comes to patient care, drug development, and understanding how their medicines perform in the
real world, GSK needs to invest in digital solutions (Agrawal, 2021).
2.3 Problems with Pharmaceutical Research, Healthcare Costs, and Patient Access:
Developing a novel medication requires extensive research, which is both time-
consuming and expensive. GSK has to keep pouring money into R&D, clinical trials, and
government oversight. It is difficult to strike a balance between these costs and the return
that could be made on the investment (Kulkarni et al., 2021).
Maintaining profitability during price negotiations with government agencies, healthcare
providers, and payers is a challenging endeavor. GSK's sales and margins are vulnerable
to price competition (Agrawal, 2021).
GSK places a premium on making its products available to as many people as possible.
To optimize the public health impact of GSK's pharmaceuticals, it is necessary to remove
barriers to access, such as price, availability, and lack of knowledge (Kulkarni et al.,
2021).
Purpose of the Report
This report's goal is to analyze the problem facing GlaxoSmithKline (GSK) in the United
Kingdom, with a special emphasis on the difficulty of Drug Pricing and Market Access. The
purpose of this research is to shed light on how fixing this problem can help GSK's business in
the long run by increasing its market share, profits, and drug accessibility. The primary goals are
to analyze the existing price landscape, investigate access impediments, and provide practical
recommendations that will help GSK develop more efficient pricing strategies, broaden patient
access to their products, and ultimately enhance patients' health.
which could lead to higher bonuses and incentives. Furthermore, when ethical pricing practices
are pushed, the company's reputation and credibility will improve (Martinalbo et al., 2016).
Employees: The success of GSK is important to all employees, from scientists to salespeople.
Better employment stability and a more pleasant workplace can arise from more liberal medicine
price regulations and more access to the market. Workers will feel more confident in their jobs
and the company's future if they know it is run ethically and has a solid financial foundation.
Increased happiness and loyalty at work may result from this (Kempe, 2020).
Shareholders: Financial results are the primary focus of GSK's shareholders, both individual
investors and institutional institutions. The results of the study will have a major effect on the
value of their investments. These outcomes will help the company boost revenues while better-
controlling risks and complying with regulations, all to the benefit of its shareholders. Stock
price increases and dividend payouts may result from this (Martinalbo et al., 2016).
Suppliers: GSK's supply chain consists of various suppliers, including raw materials and
packaging makers. The price of goods may be affected by any changes made to pricing tactics. If
GSK is successful in adopting more long-term pricing strategies, it may be able to keep its
relationships with its suppliers intact and productive. This can be useful for striking
advantageous deals and keeping the supply chain running smoothly (Simoens and Huys, 2017).
Regulatory Authorities: In the United Kingdom, the Medicines and Healthcare Products
Regulatory Agency (MHRA) is responsible for ensuring that all pharmaceutical goods meet
safety standards. These groups will be interested in the results of studies examining GSK's
pricing and market access policies. Lawsuits and fines can be avoided when pricing methods are
10
transparent and honest. Having productive conversations with regulators could improve market
conditions (D’Souza, 2023).
Local Communities: GSK's UK operations frequently take place within local communities,
generating jobs and stimulating the regional economy. The repercussions for these
neighborhoods may be severe (Sabatini, Xia and Chalmers, 2022). A healthy GSK that prices its
drugs fairly will be able to maintain its presence in these areas, providing steady employment
and stimulating the local economy. In addition, GSK's efforts to expand access to healthcare
have the potential to boost national health and well-being (Critchley and Zaric, 2019).
4 Evaluation and Analysis with Secondary Data for the Purpose of the Report
4.1 Porter 5 forces analysis:
The utilization of Porter's Five Forces model proves to be a valuable and effective analytical
framework for evaluating and comprehending the competitive dynamics that exist within a given
industry (Critchley and Zaric, 2019). When examining the issue of Drug Pricing and Market
Access encountered by GlaxoSmithKline (GSK) in the United Kingdom, this analysis aids in
comprehending the intricate dynamics of several aspects that influence the pharmaceutical
market. This analysis employs Porter's Five Forces model to examine the challenges faced by
GSK (Koçkaya and Wertheimer, 2018).
more favorable position within the supply chain than its suppliers, lowering the suppliers'
bargaining power. Toumi et al. (2023) note that GSK's capacity to manage costs and maintain
competitive pricing stems from the company's command of its supply chain.
pricing strategies to sustain and augment market penetration (Leone, Schiavone and Simoni,
2021).
to influence from Brexit and its implications on legislation and trade agreements, potentially
affecting the company's market access and pricing strategies. The allocation of healthcare
financing by the government has a significant impact on market access. The affordability and
availability of GSK's pharmaceuticals can be influenced by fluctuations in healthcare funding
and the prioritization strategies of the National Health Service (NHS) (Young, Soussi and
Toumi, 2017).
Economic Factors:
The medication pricing and market access in the UK are influenced by the broader economic
conditions of the country. A robust economy can potentially offer greater flexibility for
allocating resources towards healthcare investment, hence potentially enhancing market
accessibility. On the other hand, economic recessions might result in the implementation of cost-
containment strategies that affect the pricing of pharmaceutical drugs. The revenues and
profitability of GSK in the UK might be impacted by exchange rate swings due to its status as a
worldwide firm. The competitiveness of GSK's pricing in international markets might be
impacted by the strength of the pound. The presence of economic inequalities in the United
Kingdom can result in variances in patients' capacity to afford and access healthcare services,
hence influencing the demand for goods offered by GSK and the pricing methods employed by
the firm (Young, Soussi and Toumi, 2017).
Social Factors:
Social factors, such as shifting demographics, evolving patient expectations, and emerging health
trends, exert a significant influence on the demand for pharmaceutical products. The potential
necessity for distinct drugs in an aging population compared to a younger demographic is a
relevant consideration. The market access is driven by patient desires for convenient healthcare
access and affordable pharmaceuticals. Socioeconomic differences have the potential to give rise
to health inequities, hence impacting individuals' ability to access markets (Koçkaya and
Wertheimer, 2023). GSK should take into account the implications of its pricing strategy in
addressing these gaps and guaranteeing equitable access to its products across all demographic
segments. The extent of health literacy and understanding within a given society has the potential
to impact the decision-making process in healthcare. Patients who have received a formal
education are more inclined to actively pursue healthcare options and possess a greater
15
understanding of drug cost, which could potentially influence their ability to access the market
(Young, Soussi and Toumi, 2017).
Technological Factors:
Technological factors play a crucial role in determining the competitiveness of GSK, as
advancements in pharmaceutical research and technology are of utmost importance. The
allocation of resources towards research and development is of utmost importance to maintain a
leading position in the field of medication development. Digital health technologies, such as
telemedicine and health data analytics, have the potential to revolutionize the delivery and
accessibility of healthcare (Koçkaya and Wertheimer, 2023). To achieve optimal market access,
GSK must ensure that its products and services are in alignment with these innovative
developments. Sophisticated data analytics has the potential to offer valuable insights about
patient requirements and the efficacy of GSK's medications and pricing tactics. The integration
of data-driven decision-making has the potential to augment market access strategies and inform
drug pricing determinations (Henry, 2018).
Environmental Factors:
One of the key considerations for GSK is the growing demand for showcasing their dedication
towards environmental sustainability and corporate responsibility. Several elements have the
potential to impact the reputation and market accessibility of a company. The occurrence of
environmental changes, such as climate change, has the potential to exert an influence on illness
patterns and thus affect the demands placed on healthcare systems. GSK must take into account
the impact of climate-related conditions on its product portfolio and market accessibility (Henry,
2018).
Legal Factors:
One of the factors that GSK must consider in its operations is the legal issues, particularly those
related to patent protection. These legal considerations have a direct impact on GSK's ability to
set prices for its products and get access to the market. The expiration of patents about crucial
pharmaceuticals might result in the emergence of generic alternatives, hence influencing pricing
tactics. The market share and price decisions of GSK may be influenced by regulatory measures
about antitrust and competition. Adherence to these regulations is necessary to sustain market
accessibility (Thomas et al., 2019). The duration and expenses associated with bringing products
16
to market are influenced by legal regulations about drug approval, as well as safety and efficacy
standards. Adherence to regulatory requirements is crucial to gain entry into the market.
Although suppliers may possess limited bargaining power, it is crucial to establish robust
connections within the supply chain to effectively manage costs and maintain a reliable supply of
raw materials. In summary, the utilization of Porter's Five Forces framework to analyze the issue
of Drug Pricing and Market Access for GSK in the United Kingdom unveils the complex
intricacies of the pharmaceutical sector (Muhammad Usman Tariq, 2023). The analysis
highlights the importance of GSK in finding a careful equilibrium between pricing, innovation,
and tactics that prioritize customer needs. This will enable GSK to effectively manage the
competitive environment, secure optimal market entry, and provide value to both patients and
stakeholders (Samuel and Lucassen, 2022).
The necessity for diligent patent management and adherence to regulatory requirements is
emphasized by legal considerations to effectively address obstacles related to market entry and
pricing (Carroll and Richardson, 2017). In summary, the examination of GSK's endeavor to
address the issues of drug pricing and market access in the United Kingdom through a PESTLE
analysis underscores the intricate and ever-evolving characteristics inherent in the
pharmaceutical sector (Xu et al., 2020). Comprehending these external aspects is crucial for
GSK's capacity to adjust to market situations, make well-informed pricing determinations, and
guarantee the availability of healthcare products for patients while simultaneously providing
value to stakeholders (Imran, Ghannam and Abbasi, 2020).
Collaborative Pricing Strategies: GSK should work with government agencies, healthcare
systems, and advocacy groups to develop sustainable pricing strategies that meet the needs of
both patients and the healthcare system (Baus et al., 2017). Equal access to pharmaceuticals is
ensured and the interests of purchasers with high bargaining power (patients and healthcare
providers) are addressed (Yoon, Lee and Shin, 2020).
Research and Development Investment: GSK should keep spending money on R&D so that it
can stay ahead of the competition and keep up with shifting healthcare preferences. Research that
focuses on customized medicine and digital health solutions, for example, has the potential to
18
yield novel treatments that find favor with both patients and healthcare systems (Reveilhac and
Blanchard, 2022).
Market Access Strategies: Given the UK's socioeconomic divide, GSK would be well to devise
market access methods that can flex to meet changing conditions. This includes making sure
products are available to all demographics of the population and taking into account the cost of
pharmaceuticals for patients from all socioeconomic backgrounds when designing access
initiatives (Bohr and Memarzadeh, 2020).
Sustainability and Corporate Responsibility: GSK needs to keep showing its dedication to
sustainability and corporate responsibility if it wants to improve its reputation and live up to
rising environmental and societal standards. Market entry may be improved if this conforms to
the expectations of customers and authorities (Vuppalapati, 2021).
Data-Driven Decision-Making: GSK may get important insights into patient demands and
product efficacy by adopting advanced data analytics and implementing data-driven decision-
making into pricing and market access initiatives. Data-driven pricing techniques have the
potential to be more accurate and specific (Vuppalapati, 2021).
Patient-Centric Approach: GSK would be wise to focus on patients in light of the substantial
leverage patients and healthcare providers enjoy in negotiations. Creating products that are
tailored to the needs of individual patients includes patient assistance programs, communicating
prices openly, and researching and developing innovative treatments (Nagamine et al., 2022).
Supply Chain Optimization: GSK should prioritize supply chain optimization despite suppliers'
limited bargaining strength. Maintaining low prices and a constant supply of raw materials calls
for well-established partnerships with suppliers, streamlined logistics, and careful contingency
planning (Vuppalapati, 2021).
19
Proactive Patent Management: The patent portfolio is something that GSK needs to carefully
manage. GSK will be able to maintain its competitive edge by adjusting its pricing strategy in
advance of patent expirations and anticipation of generic competition (Dhingra et al., 2023).
Government Relations and Advocacy: GSK can take the initiative to affect healthcare policy
and regulation by establishing strong government contacts and engaging in advocacy campaigns.
As a result, prices and access to the market may improve (Prahalad, Palma and Chen, 2022).
Engage with Local Communities: GSK has to keep working with and investing in the
neighborhoods where it has facilities. GSK's ability to be a reliable employer and contributor to
the local economy depends on its good standing in the community and its rapport with its various
stakeholder groups (Marsch, 2020).
The advice given is meant to help GSK navigate this difficult landscape. They stress the need for
cooperative pricing solutions that balance revenue and cost. GSK's future R&D efforts should
prioritize adapting to changes in the healthcare industry, such as the rise of customized medicine
and the adoption of digital health solutions. To improve drug accessibility, market access
methods must be adaptable to meet socioeconomic inequalities and take a patient-centred
approach. In addition, GSK needs to keep an eye on the changing regulatory landscape after
Brexit and make sure it is always in compliance. When GSK demonstrates its dedication to
sustainability and corporate responsibility, it meets the expectations of both society and
regulators. The pharmaceutical industry relies heavily on data-driven decision-making and
20
supply chain optimization. An already advantageous pricing and market access climate can be
further shaped by proactive patent management and government contacts and advocacy. Finally,
GSK's involvement in local communities bolsters its reputation as a good corporate citizen.
In sum, GSK has a complex problem with drug pricing and market access in the UK, which is
affected by a wide range of internal and external variables. There must be a careful balancing act
between innovation, compliance, collaboration, and a focus on the patient if this problem is to be
overcome. GSK can maintain its leadership position in the pharmaceutical industry, providing
meaningful benefits to patients while maintaining its financial viability, by following the advice
offered in this paper. GSK in the UK may face new challenges in the future as the
pharmaceutical sector and the factors driving it evolve. Therefore, GSK should consider this
study a living road map and maintain a strategy of flexibility, prepared to respond to emerging
possibilities and threats. In conclusion, GSK, as a frontrunner in the pharmaceutical sector, has
the resources and duty to tackle these issues head-on in the United Kingdom. GSK can prosper
as a responsible corporate entity while adapting to a changing pharmaceutical landscape by
placing a premium on patient well-being, actively engaging with stakeholders, and embracing
innovation.
21
6 References:
Agrawal, A. (2021). Cognitive Compliance for Financial Regulations. [online]
ieeexplore.ieee.org. Available at: https://ieeexplore.ieee.org/abstract/document/8012296/
[Accessed 11 Oct. 2023].
Baus, A., Coben, J., Zullig, K., Pollard, C., Mullett, C., Taylor, H., Cochran, J., Jarrett, T. and
Long, D. (2017). An Electronic Health Record Data-driven Model for Identifying Older Adults
at Risk of Unintentional Falls. Perspectives in Health Information Management, [online]
14(Fall). Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5653950/.
Carroll, N. and Richardson, I. (2017). Aligning healthcare innovation and software requirements
through design thinking. Proceedings of the International Workshop on Software Engineering in
Healthcare Systems. doi:https://doi.org/10.1145/2897683.2897687.
Chen, Y., Hu, S., Dong, P., Kornfeld, Å., Jaros, P., Yan, J., Ma, F. and Toumi, M. (2022). Drug
pricing reform in China: analysis of piloted approaches and potential impact of the reform.
Journal of Market Access & Health Policy, 4(1), p.30458.
doi:https://doi.org/10.3402/jmahp.v4.30458.
Critchley, G.J. and Zaric, G.S. (2019). The impact of pharmaceutical marketing on market
access, treatment coverage, pricing, and social welfare. Health Economics, 28(8), pp.1035–1051.
doi:https://doi.org/10.1002/hec.3903.
D’Souza, P. (2023). Pharma Pricing & Market Access Europe 2016 - Health Network
Communications’ Tenth Annual Conference (February 23-25, 2016 - London, UK). Drugs of
Today, 52(3), p.203. doi:https://doi.org/10.1358/dot.2016.52.3.2480580.
Dahir, C.A., Cinotti, D.A. and Feirsen, R. (2019). Beyond Compliance: Assessing
Administrators’ Commitment to Comprehensive School Counseling. NASSP Bulletin, 103(2),
pp.118–138. doi:https://doi.org/10.1177/0192636519830769.
22
Dhingra, L.S., Shen, M., Mangla, A. and Khera, R. (2023). Cardiovascular Care Innovation
through Data-Driven Discoveries in the Electronic Health Record. The American Journal of
Cardiology, [online] 203, pp.136–148. doi:https://doi.org/10.1016/j.amjcard.2023.06.104.
Gittfried, N., Lenhard, E., Bohmayr, W. and Helbing, C. (2020). WHEN AGILE MEETS
REGULATORY COMPLIANCE. [online] Available at: https://web-assets.bcg.com/img-src/BCG-
When-Agile-Meets-Regulatory-Compliance-July-2017-2_tcm9-162794.pdf [Accessed 11 Oct.
2023].
Imran, M.A., Ghannam, R. and Abbasi, Q.H. (2020). Engineering and Technology for
Healthcare. [online] Google Books. John Wiley & Sons. Available at:
https://books.google.com/books?
hl=en&lr=&id=34UIEAAAQBAJ&oi=fnd&pg=PR13&dq=2.1%09Healthcare+Innovation+in+L
ight+of+Current+Trends&ots=5GsbAQTQcQ&sig=m6yxWV842NYFpD5CPYc3JEj7Oog
[Accessed 11 Oct. 2023].
Ip, W., Prahalad, P., Palma, J. and Chen, J.H. (2022). A Data-Driven Algorithm to Recommend
Initial Clinical Workup for Outpatient Specialty Referral: Algorithm Development and
Validation Using Electronic Health Record Data and Expert Surveys. JMIR Medical Informatics,
10(3), p.e30104. doi:https://doi.org/10.2196/30104.
Jayaraman, P.P., Forkan, A.R.M., Morshed, A., Haghighi, P.D. and Kang, Y. (2019). Healthcare
4.0: A review of frontiers in digital health. WIREs Data Mining and Knowledge Discovery,
10(2). doi:https://doi.org/10.1002/widm.1350.
Johansson, E., Sutinen, K., Lassila, J., Lang, V., Martikainen, M. and Lehner, O. (2019).
REGTECH-A NECESSARY TOOL TO KEEP UP WITH COMPLIANCE AND
REGULATORY CHANGES? ACRN Journal of Finance and Risk Perspectives, [online] 8,
pp.71–85. Available at: http://www.acrn-journals.eu/resources/SI08_2019f.pdf.
23
Kulkarni, V., Sunkle, S., Kholkar, D., Roychoudhury, S., Kumar, R. and Raghunandan, M.
(2021). Toward automated regulatory compliance. CSI Transactions on ICT.
doi:https://doi.org/10.1007/s40012-021-00329-4.
Leone, D., Schiavone, F. and Simoni, M. (2021). Key account management and value co-
creation in multi-stakeholder ecosystems. A ‘market access’ mix. Journal of Business &
Industrial Marketing, 36(13), pp.199–209. doi:https://doi.org/10.1108/jbim-05-2019-0256.
Marsch, L.A. (2020). Digital health data-driven approaches to understand human behavior.
Neuropsychopharmacology. doi:https://doi.org/10.1038/s41386-020-0761-5.
Martinalbo, J., Bowen, D., Camarero, J., Chapelin, M., Démolis, P., Foggi, P., Jonsson, B.,
Llinares, J., Moreau, A., O’Connor, D., Oliveira, J., Vamvakas, S. and Pignatti, F. (2016). Early
market access of cancer drugs in the EU. Annals of Oncology, 27(1), pp.96–105.
doi:https://doi.org/10.1093/annonc/mdv506.
Moreno, S.G. and Epstein, D. (2019). The price of innovation - the role of drug pricing in
financing pharmaceutical innovation. A conceptual framework. Journal of Market Access &
Health Policy, 7(1), p.1583536. doi:https://doi.org/10.1080/20016689.2019.1583536.
24
Muhammad Usman Tariq (2023). Healthcare Innovation & Entrepreneurship, Digital Health
Entrepreneurship. pp.243–258. doi:https://doi.org/10.1007/978-981-19-6696-5_16.
Nagamine, T., Gillette, B., Kahoun, J., Burghaus, R., Lippert, J. and Saxena, M. (2022). Data-
driven identification of heart failure disease states and progression pathways using electronic
health records. Scientific Reports, 12(1). doi:https://doi.org/10.1038/s41598-022-22398-4.
Prokopchuk, S., Zhivotov, D.A., Pastukh, O. and Aleksandr Panin (2022). Innovative Medicine:
What Challenges Does It Pose to Designers and Developers? Lecture notes in civil engineering,
pp.205–210. doi:https://doi.org/10.1007/978-3-030-99877-6_24.
Reveilhac, M. and Blanchard, A. (2022). The framing of health technologies on social media by
major actors: Prominent health issues and COVID-related public concerns. International Journal
of Information Management Data Insights, 2(1), p.100068.
doi:https://doi.org/10.1016/j.jjimei.2022.100068.
Runfola, A., Guercini, S. and Milanesi, M. (2021). Network interactions for pharmaceutical
market access: findings from an explorative research. Journal of Business & Industrial
Marketing, 36(13), pp.174–186. doi:https://doi.org/10.1108/jbim-07-2020-0371.
Sabatini, M.T., Xia, T. and Chalmers, M. (2022). Pricing and Market Access Challenges in the
Era of One-Time Administration Cell and Gene Therapies. Pharmaceutical Medicine, 36(5),
pp.265–274. doi:https://doi.org/10.1007/s40290-022-00443-x.
Samuel, G. and Lucassen, A.M. (2022). The environmental sustainability of data-driven health
research: A scoping review. DIGITAL HEALTH, 8, p.205520762211112.
doi:https://doi.org/10.1177/20552076221111297.
Sendyona, S., Odeyemi, I. and Maman, K. (2023). Perceptions and factors affecting
pharmaceutical market access: results from a literature review and survey of stakeholders in
different settings. Journal of Market Access & Health Policy, [online] 4.
doi:https://doi.org/10.3402/jmahp.v4.31660.
25
Simoens, S. and Huys, I. (2017). Market access of Spinraza (Nusinersen) for spinal muscular
atrophy: intellectual property rights, pricing, value and coverage considerations. Gene Therapy,
[online] 24(9), pp.539–541. doi:https://doi.org/10.1038/gt.2017.79.
Thomas, D., John, D., Ashoush, N., Lega, F. and Li, H. (2019). Chapter 17 - Market Access,
Pharmaceutical Pricing, and Healthcare Costs. [online] ScienceDirect. Available at:
https://www.sciencedirect.com/science/article/pii/B9780128142769000179.
Tompa, E., Kalcevich, C., Foley, M., McLeod, C., Hogg-Johnson, S., Cullen, K., MacEachen, E.,
Mahood, Q. and Irvin, E. (2022). A systematic literature review of the effectiveness of
occupational health and safety regulatory enforcement. American Journal of Industrial Medicine,
59(11), pp.919–933. doi:https://doi.org/10.1002/ajim.22605.
Toumi, M., Jarosławski, S., Sawada, T. and Kornfeld, Å. (2023). The Use of Surrogate and
Patient-Relevant Endpoints in Outcomes-Based Market Access Agreements. Applied Health
Economics and Health Policy, 15(1), pp.5–11. doi:https://doi.org/10.1007/s40258-016-0274-x.
Vuppalapati, C. (2021). The Role of Big Data in Creating Sense EHR, an Integrated Approach
to Create Next Generation Mobile Sensor and Wearable Data Driven Electronic Health Record
(EHR). [online] ieeexplore.ieee.org. Available at:
https://ieeexplore.ieee.org/abstract/document/7474387/ [Accessed 11 Oct. 2023].
Xu, J., Wang, F., Xu, Z., Adekkanattu, P., Brandt, P., Jiang, G., Kiefer, R.C., Luo, Y., Mao, C.,
Pacheco, J.A., Rasmussen, L.V., Zhang, Y., Isaacson, R. and Pathak, J. (2020). Data ‐driven
discovery of probable Alzheimer’s disease and related dementia subphenotypes using electronic
health records. Learning Health Systems, 4(4). doi:https://doi.org/10.1002/lrh2.10246.
Yoon, S.N., Lee, D. and Shin, Y. (2020). Innovative Healthcare Wearable Device Usage and
Service Enhancement. GLOBAL BUSINESS FINANCE REVIEW, 25(2), pp.1–10.
doi:https://doi.org/10.17549/gbfr.2020.25.2.1.
Young, K.E., Soussi, I. and Toumi, M. (2017). The perverse impact of external reference pricing
(ERP): a comparison of orphan drugs affordability in 12 European countries. A call for policy
26