Global Public Health

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Access to innovative medicines by pharma

companies: Sustainable initiatives for global
health or useful advertisement?

Michele de Medeiros Rocha, Emmanuel Paiva de Andrade, Edna Ribeiro

Alves, João Carlos Cândido & Marcello de Miranda Borio

To cite this article: Michele de Medeiros Rocha, Emmanuel Paiva de Andrade, Edna Ribeiro
Alves, João Carlos Cândido & Marcello de Miranda Borio (2020) Access to innovative medicines by
pharma companies: Sustainable initiatives for global health or useful advertisement?, Global Public
Health, 15:6, 777-789, DOI: 10.1080/17441692.2020.1729391

To link to this article: https://doi.org/10.1080/17441692.2020.1729391

Published online: 18 Feb 2020.

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GLOBAL PUBLIC HEALTH
2020, VOL. 15, NO. 6, 777–789
https://doi.org/10.1080/17441692.2020.1729391

Access to innovative medicines by pharma companies:

Sustainable initiatives for global health or useful advertisement?
Michele de Medeiros Rocha, Emmanuel Paiva de Andrade, Edna Ribeiro Alves, João
Carlos Cândido and Marcello de Miranda Borio
Engineering School, Federal Fluminense University, Niterói, Brazil

ABSTRACT ARTICLE HISTORY

Research & Development on new medicines plays an important role in life Received 1 August 2019
and well-being, making pharmaceutical companies important players in Accepted 10 February 2020
global health. Accessibility and financing new medicines, however, poses
KEYWORDS
challenges for governments and patients around the world. Due to Access to medicine; global
pricing and aggressive patent policy issues, pharma companies started health; innovation;
to adopt access to medicines as a strategy to not only improve their pharmaceutical; social
public image but also to increase their economic performance. More responsibility
than a useful institutional advertisement to attract new business,
initiatives to improve access to medicines must be socially responsible
and sustainable. Using content analysis methodology from CSR reports,
the present study evaluated how 44 global companies are positioning
themselves regarding access, whether these initiatives are aligned to
existing access programmes and whether the actions disclosed on
behalf of access are sustainable. We have identified 13 major access to
medicines approaches that were classified into intrinsic, potentially
sustainable and robust actions. We concluded that companies overvalue
the term access to medicine. This can generate initiatives focused on
advertisements rather than long-term actions and highlights the need
for clear global criteria for companies and programmes that want to
effectively publicise access to medicines as a social responsibility strategy.

1. Introduction
Health is the third of the seventeen Sustainable Development Goals (SDGs) established in 2015 at the
United Nations Summit. In this context, research on new medicines plays an important role in main-
taining adequate levels of health and well-being (Jaruzelski, Loehr, & Holman, 2011; Sachs, 2015).
There is mixed criticism, however, as to how the pharmaceutical industry innovates. Members of
the medical community believe that the industry only focuses on developing more expensive medi-
cines, losing interest in producing cheaper, equally effective medications that would be more afford-
able for the population. Simply put, access refers to people’s ability to properly obtain and use good
quality health technologies when they are needed (Roberts & Reich, 2002). Accessibility and finan-
cing new medicines also poses challenges for governments of developed and developing countries
around the world that need decide which of the new medicines manufactured by the industry will
be included as part of their health services. This condition makes pharmaceutical companies impor-
tant players in global health (Abou-Gharbia & Childers, 2014; Almeida & Viana Freire, 2018; Biehl
et al., 2019; Miller, Moos, Munk, & Munk, 2016).

CONTACT Michele de Medeiros Rocha michele_rocha@id.uff.br Engineering School, Federal Fluminense University, Passo
da Pátria St., 156 – São Domingos, Niterói 24210-240, RJ, Brazil
© 2020 Informa UK Limited, trading as Taylor & Francis Group
778 M. D. M. ROCHA ET AL.

Society has also demanded that the pharmaceutical industry take on a role in health promotion.
In this sense, access to medicines has already begun to shape companies’ policies, both to improve
their economic performance and their public image, which has eroded in recent decades due to pri-
cing and aggressive patent policy issues (da Fonseca, 2018; Herzog, 2017; Hogerzeil, 2013; Lee &
Hunt, 2012).
The creation of the Access to Medicine Index (ATMi) in 2008, for example, was in the best inter-
est of the top 20 global pharmaceutical companies, which began to disclose and be evaluated bien-
nially on their policies and achievements regarding access (ATM, 2018; Cole, Trolle, & Edwards,
2018; Quak, Heilbron, & Meijer, 2019). With indicators similar to ATMi, in 2017 the International
Federation of Pharmaceutical Manufacturers & Associations (IFPMA) created the Access Acceler-
ated (AA) platform. The platform aims to join efforts by biopharmaceutical companies to address
the huge burden of Noncommunicable Diseases (NCDs), such as cancer and diabetes, in low-
and middle-income countries as a way to support the progress of the United Nations’ SDGs (Anon-
ymous, 2018; Perehudoff, Alexandrov, & Hogerzeil, 2019).
By engaging in these initiatives, companies aim to be accountable to society and, in particular, to
favourably advertise their actions to shareholders and institutional investors, who can assess whether
pharmaceutical companies are gaining strength in emerging markets (Leisinger, 2005). Thus, not
only ATMi and AA participants, but also other companies find it strategic to publicise their access
to medicine initiatives and their best practices through Annual Results Reports (or even Corporate
Social Responsibility – CSR Reports) aiming to improve their business results (Brammer & Milli-
ngton, 2005; Collins, 1993; Peterson, 2018; Saiia, Carroll, & Buchholtz, 2003).
More than a useful institutional advertisement to attract new business, access to medicine initiat-
ives are socially responsible and must be sustainable. In general, the concept of corporate sustainabil-
ity is based on a three-dimensional perspective (economic, ecological and social) (Gimenez, Sierra, &
Rodon, 2012), which has been enhanced by the inclusion of a dimension related to the time horizon
required for the desired effects to be realised and measured in the long term (Dyllick & Hockerts,
2002; Lozano, Carpenter, & Huisingh, 2015; Wang & Bansal, 2012). In line with this understanding,
the World Health Organization (WHO) has already expressed concern about exaggerated access
initiatives by companies, which may lead them to draw up schedules that are unclear, short-term
and/or without transition plans to ensure the continuity of these activities, thereby compromising
their sustainability. Thus, the long-term sustainability perspective converges with the adoption of
socially responsible practice, constituting itself as the main pillar of access to medicines (Nidumolu,
Prahalad, & Rangaswami, 2009; WHO, 2017).
This paper aims to examine whether pharmaceutical companies’ access to medicines initiatives
are likely to be sustainable in the long term or only useful advertisement for the business. We do
this using an evaluation perspective that differs from the ATMi and AA programmes. To this
end, we evaluate how innovation pharmaceutical companies are publicly positioning themselves
regarding access, and analyse and critically rank the access to medicine strategies they disseminate.

2. Methodology and organisation of the study

The exploratory research took as a sample the global companies linked to medicine innovation. Data
collection was done through documentary analysis of the Annual Results Reports and/or CSR
Reports of the 44 global companies associated to the European Federation of Pharmaceutical Indus-
tries and Associations (EFPIA). The EFPIA represents the research-based pharmaceutical industries
operating in Europe, and/or companies affiliated to the International Federation of Pharmaceutical
Manufacturers & Associations (IFPMA), which represents the research-based pharmaceutical com-
panies and associations across the globe.
Data analysis followed the content analysis methodology (Bardin, 1977), with procedures are
divided into 3 phases: (a) Pre-analysis: definition of the indicators that guided data collection; (b)
Material exploration: data collection from previously selected sources, coding, decomposing or
 GLOBAL PUBLIC HEALTH 779

enumerating the data; (c) Treatment of the obtained results: transformation of the raw data,
obtained in material exploration stage, into significant and valid data. Figure 1 outlines the organ-
isation of the study and presentation of the results:

2.1. Pre-analysis
2.1.1. Definition of indicators
Data collection was performed in the last quarter of 2018 in the Annual Results Reports and/or CSR
Reports using the last yearly report available on the websites of 44 EFPIA and/or IFPMA member
companies.
The indicators that guided the data collection in the reports were defined based on the access
activities present in the Frost and Reich (2008) framework. Frost and Reich carried out a study com-
missioned in 2005 by the Gates Foundation, one of the ATMi Founders, to explore the issue of access
to health in the economic and social contexts (Birn, 2005).
The access activities of this framework include the 4As of access: architecture, which covers
organisational structures and relationships established with the purpose of access; availability,
which emphasises access provisioning components, from manufacturing and distribution to delivery
to the end-user; affordability, which involves cost issues for the various players; and adoption,
which includes demand and acceptance factors for a new technology.

2.2. Material exploration

2.2.1. Coding
We established codes for the access to medicine strategies disclosed by the 44 companies based on
the access activities that emerged from the reports. We chose not to use data collection software for
two main reasons: (1) the diversity of contexts in which the indicators were inserted, which required
a careful look at the belonging and comparability of the contexts; (2) to be able to select excerpts that
indicate concrete activities disseminated by the companies in the name of access, which required
familiarity with the general context of the research.

Figure 1. Organisation of the study. Source: Prepared by the authors.

780 M. D. M. ROCHA ET AL.

The collection was also not intended to verify whether the same strategy was cited more than once
in the reports because the purpose was to identify whether or not a company adopted a particular
strategy. Thus, excerpts of the text were identified, extracted and coded according to the context
in which the access activities appeared in the reports. Examples of how the coding strategy was per-
formed can be found in the following excerpts:
The statement “We also develop biosimilar versions of biologics for patients in Europe. These similar but not
identical biologic therapies will allow us to deliver effective treatments at reduced prices - and further increase
access to medicines that can make a meaningful difference for patients” indicates that the company produces
and considers biosimilars medicines as a strategy for accessing medicines. Therefore, this passage was initially
coded as ‘biosimilar’.

The statement ‘We are a founding member of the Accessibility Platform, an informal, private-sector
initiative that is working on a comprehensive approach to meeting supply chain and distribution
challenges in developing countries’ was coded as ‘logistic/distribution’.

2.2.2. Standardisation of codes

Several codes emerged from the evaluation of access activities disclosed by the companies and, to
facilitate further analysis, they were standardised. For example, ‘patient education’, ‘education for
health professionals’ and ‘education for patients and health professionals’ were standardised as
variations of a major code named ‘education’. In turn, ‘patent licensing’, ‘patent transparency’
and ‘non-filing of patents in countries’ have been standardised as variations of the main code
‘patents’.

2.3. Treatment of results obtained

2.3.1. Categorisation
Using categories helps to group elements, ideas, or expressions around already used concepts (Yin,
1994). Therefore, after coding the previous step, the codes were grouped against the Access to Medi-
cine Index (ATM, 2017) and AA (Anonymous, 2018) criteria in order to also conceptually analyze
the companies’ adherence to the access strategies disclosed by companies to ATM and AA
programmes.

2.3.2. Data summary

After evaluating the 44 companies’ reports, the following codes/strategies in the name of access to
medicines emerged in the contexts described below. The complete coding and categorisation
together with absolute (A) and relative (R) codes frequency is given below:
The major strategies disclosed by each company are summarised in the picture below
(Figure 2):

3. Discussion of results
Ten out of the 14 companies that reported 5 or more access actions each were participating in one
of the access programmes (ATMi and/or AA), suggesting that these programmes may stimulate
such company initiatives. Ten of the 15 companies that did not participate in any of the ATMi
and/or AA indices presented at least one initiative, which indicates that access to medicines is
already starting to be part of the companies’ agenda, even if they do not formally participate in
any access programme.
Below is a discussion of the data organised according to the categories presented in Table 1 and
analysed for adherence to ATMi and AA criteria and the proposed study objectives.
 GLOBAL PUBLIC HEALTH 781

Figure 2. Companies’ key strategies for access to medicines. Source: Prepared by the authors. (*) Companies not represented at
ATMi or AA.

3.1. Patents & licensing category

3.1.1. Patenting strategy & licensing _ Strategy disclosed by companies: Generics, biosimilars
and patents
The way companies manage their intellectual property (IP) affects the availability and accessibility of
medicines. Therefore, in ATMi’s view of the IP strategy, companies are expected to be clearer about
their patents or even not to protect their products in some countries in order to facilitate generic
entry into new markets, stimulate competition and lower prices. Similarly, in relation to licensing,
they are expected to practice it in order to make patented medicines available through the production
of generics in middle-income countries.
Although conceptually convergent with the criteria adopted by ATMi and AA, the strategies
reported by the companies show that there is still a lot of protectionism regarding patents, since
only 11 companies demonstrated using this strategy as one for access to medicines. Voluntary patent
licensing is the most widespread one, although it can only be considered as an access strategy if there
were actually lower prices guaranteed to the population (which is clear only among the 9% of com-
panies that reported patent licensing to the Medicines Patent Pool (MPP), which makes patents
available to multiple manufacturers to produce and distribute generic versions of patented medicines
in developing countries). Regarding the production of licensed generics and biosimilars, only 8 and 5
companies, respectively, disclosed this strategy as being accessible, which can be due to their core
business being more directed towards innovative medicines (Iyengar et al., 2016; Juneja, Gupta,
Moon, & Resch, 2017).
Because companies are often unclear about their patents, we considered being transparent in dis-
closing their inventions (27% of the patent strategy) as a real access initiative because it facilitates
copy generation. In the same way, 27% are actions related to the non-filing of patents in the poorest
countries, meaning that even though it has the exclusive right, the company opts for this strategy to
782 M. D. M. ROCHA ET AL.

Table 1. Strategies used by pharmaceutical companies in the name of access.

Code _major Category according to Access to
strategy /(A) Strategy variations/(R) Context Medicine Index (ATM, 2017)
Biosimilars (5) – … access by availability of biosimilar’s PATENTS & LICENSING (*) /
manufacturing, cheaper than the Licensing
biological original [WD]
Generics (8) – … access by availability of generic’s
manufacturing, cheaper than the original
medicine [WD]
Patents (11) transparency (27%) … access through patent strategies PATENTS & LICENSING (*) /
voluntary licensing (voluntary license, transparency in Patenting strategy and
(37%) documentation, non-deposit in poor Licensing
non-deposit in poor countries and patent pool without cost)
countries (27%) for end-user affordability [WD]
licensing to MPP (9%)
Donation (18) of money (46%) … access through donation of medicines, PRODUCT DONATIONS (*)/ Scale
of medicines (47%) money and / or diagnostic actions to and reach
diagnostic resources NGOs or health-related foundations as a
donations (7%) way to deliver a new health technology
[WD]
Education (25) health care professional … access through the education of CAPACITY BUILDING / Health
(HCP) (38%) patients (information on the disease, system strengthening (*)
patients (62%) correct use of medication) and health
professionals (on the disease, diagnosis,
handling treatment) for the adoption of
the new pharmaceutical technology by
the population [WD]
Logistic/ distribution – … access through solutions or new CAPACITY BUILDING / Supply
(9) initiatives in the logistics chain for better chain capacity building (*)
distribution and delivery of drugs to
remote places [WD]
R&D through with institutes (15%) … access through the availability of new CAPACITY BUILDING / R&D
patnerships (17) with universities (57%) medicines after R & D made possible capacity building (*)
with companies (14%) through partnerships with companies,
with hospitals (14%) hospitals, institutes and / or universities
[WD]
Price (24) lower prices in … access through variable / lower prices in PRICING, MANUFACTURING &
partnerships with developed or low-income countries (for DISTRIBUTION / Equitable
NGOs (48%) certain diseases) usually through pricing strategies (*)
lower prices in partnership with governments or NGOs,
developed or low- for availability of medicines [WD]
income countries
(52%)
Presence in countries with factory (44%) … access by means of presence in PRICING, MANUFACTURING &
(9) developing countries (factories and / or DISTRIBUTION / Manufacturing
registered products) for adoption of the capacity building (*)
through marketing new health technology by the population /Filing for marketing approval/
authorisation (56%) [WD] registration (*)
Product- – … access through the availability of RESEARCH AND DEVELOPMENT /
Development medicines developed through PDPs, Product development (*)
Partnership (PDP) which is a collaborative partnership
(16) between industry and the public sector
(source: WHO)
Clinical trials (3) – … access to drugs through the RESEARCH AND DEVELOPMENT /
participation of patients in clinical trials Clinical trial conduct
[WD]
Expanded Access – … access through expanded access
Programme (2) (sometimes called ‘compassionate use’)
which is a potential pathway for a patient
with an immediately life-threatening
condition or serious disease or condition
to gain access to an investigational
medical product (source Food Drug
Administration – FDA)
– –

(Continued)
 GLOBAL PUBLIC HEALTH 783

Table 1. Continued.
Code _major Category according to Access to
strategy /(A) Strategy variations/(R) Context Medicine Index (ATM, 2017)
Patient Support … access through PSPs, which is typically
Program (PSP) (12) done by supplementing and reinforcing
care and provided by the patient’s HCP or
by providing or arranging financial
assistance for patients (source European
Medicines Agency – EMA)
(*) Common ATMi and AA categories.
WD = Working description, used for analysis.
Source: prepared by the authors.

avoid an impending compulsory license (Kuek, Phillips, & Kohler, 2011), and/or to enter a new mar-
ket even with the onus and risk of competing for its product on an equal basis with its copies, which
forces the company to develop and combine other more competitive and attractive strategies for its
products.
Thus, among all variations of this category, patent non-filing in poorer countries, greater trans-
parency, MPP licensing, and generic and biosimilar production are generally not only useful adver-
tisements but can be considered robust initatives. Given their long-term characteristics, they can also
be considered as sustainable both for implementation and the difficulty of discontinuing actions due
to risks of image damage and/or cost generation to other stakeholders.

3.2. Product donations category

3.2.1. Scale and reach _ Strategy disclosed by companies: Donation
Product donation is an important tool for improving access to medicines under specific circum-
stances, such as: the control, elimination or eradication of diseases that affect poorer populations,
during humanitarian crises or even to support governments with severely limited budgets
(Cohen, Silva, Cohen, Awatin, & Sturgeon, 2016). For ATMi (2017), companies are expected to
expand their programmes to more countries and beneficiaries, with the reach of donation pro-
grammes depending on the course of treatment (e.g. short versus long term).
Conceptually converging with the criteria already adopted by ATMi and AA, donation was the
strategy cited by 18 companies, with 46% referring to drug donations, 7% referring to diagnostic
resources donations and 47% referring to the donation of money to agencies such as Global Health
Innovation Grants (GHIG) and GHIT Fund Neglected tropical diseases.
Despite their relevance in certain circumstances, donations can be considered useful advertise-
ments because they are volatile, unsustainable strategies that can even complicate the healthcare sys-
tem. Poorly implemented initiatives can place burdens on recipient countries, wasting money,
human resources and time, and can have long-term implications for the healthcare system, the
environment, and the pharmaceutical market (Baker & Ombaka, 2009; WHO, 2017). Thus, this
strategy can become potentially sustainable only if the donation of resources or medicines is predict-
able and aligned with government needs (Thorsteinsdóttir, Ovtcharenko, & Kohler, 2017).

3.3. Capacity building category

3.3.1. Health system strengthening _Access strategies disclosed by companies: Education
Getting people to use a new medicine as specified can be profoundly challenging as health technol-
ogies can be used in unforeseen ways, which makes educating health professionals and patients
important for the long-term healthcare system (Levy, 1994; McAlister, Lawson, Teo, & Armstrong,
2001; Steve, 2005). For ATMi (2017), robust health systems must be in place in order for products to
be deployed, prescribed and administered efficiently; all of which requires trained health
784 M. D. M. ROCHA ET AL.

professionals, diagnostic capacity, data-management systems, and more. Large pharmaceutical com-
panies have the expertise and the capacity to strengthen local health systems to address local needs
while also avoiding conflicts of interest.
Conceptually converging with the criteria already adopted by ATMi and AA, education was dis-
closed by 25 companies and is the most used access strategy. Thirty eight per cent of the education
actions were directed to health professionals, which demands caution not to cause undue influence
on prescription and medicine purchase practices (Kohler, Martinez, Petkov, & Sale, 2016; Rodwin,
2013; Wazana, 2000). When educational initiatives target patients, this responsibility becomes even
greater because the line between education and indirect advertising can be very thin and possibly
lead to irrational medicine use (Bélisle-Pipon & Williams-Jones, 2015; Kim, 2015). Therefore, for
these cases, educational actions should take place within the scope of disease knowledge, diagnoses
and preferably in partnership with NGOs or even the government (as was disclosed by all companies
that used this strategy, which was included in 62% actions regarding education). Due to its inherent
long-term repercussion, responsible education is not only a useful advertisement but also a robust
and sustainable access strategy.

3.3.2. Supply chain capacity building _ Strategy disclosed by companies: Logistics and
distribution
Strategies to improve logistics and distribution that ensure the accessibility, availability and even
quality of an innovation are needed in order to expand access to medicines in developing countries
and are important for adopting new health technologies (Frost & Reich, 2008). According to ATMi,
companies should engage with relevant, local partners to identify bottlenecks and improve capacity
for good supply chain management (ATM, 2017).
Conceptually converging with the criteria already adopted by ATMi and AA, 9 companies dis-
closed access strategies in relation to improvements in the logistics chain and distribution (either
through partnerships to expand distribution, or even through the creation of communication chan-
nels to inform about availability of medicines in a given region). Considering the pull supply chain
strategy, if the innovation is not adopted, there is a risk of returning goods and, consequently,
damage to the company (Simchi-Levi, Kaminsky, & Simchi-Levi, 2004). This means that if there
is no guarantee of consumption in a region that the company finds attractive, distribution to a
location can be quickly and easily interrupted. Thus, effective logistics is potentially sustainable if
the new technology is equally adopted.

3.3.3. R&D capacity building _ Strategy disclosed by companies: R&D through partnerships
Because medicine Research & Development (R&D) is risky and costly, partnering is a useful knowl-
edge and risk sharing strategy (Rocha, Vieira, Lima, De Andrade, & Quelhas, 2017). For ATMi
(2017),
companies have the expertise and ability to support the development of a skilled R&D sector in low and middle-
income countries. Engagement efforts aimed at building local R&D capacity support the development of
research skills that can enable local researchers to address relevant health needs and priorities, companies
are expected to collaborate with local universities or public sector research organizations to identify and address
local skills gaps or infrastructure needs having a long-term impact on local R&D capacity and align with the
goals of the research institution.

Analyzing the results of this category, we found that the strategies disclosed by 17 companies relating
to R&D through partnerships differed slightly from the criteria already adopted by ATMi and AA
because there was no evidence that they occurred in low and middle-income countries. For these
companies, facilitating the entry of new drugs through partnerships is an access strategy, and
included widely used partnerships with universities (57%), followed by research institutes (15%),
hospitals (14%) and even other companies (14%). Intrinsic to the goals of portfolio growth, R&D
through partnerships is a useful advertisement because it fosters innovation, shares costs, knowledge,
 GLOBAL PUBLIC HEALTH 785

resources and lowers risk. It cannot, however, be considered by itself as a way to provide access to
medicines because, as Frost and Reich (2008, p. 200) state, ‘developing a safe and efficacious tech-
nology is necessary but not sufficient for ensuring technology access and health improvement. Pro-
ducts do not fly off the shelf on their own’.

3.4. Pricing, manufacturing & distribution category

3.4.1. Equitable pricing strategies _ Strategy disclosed by companies: Price
According to Frost and Reich (2008), strategies to expand access must address affordability and, for
ATMi (2017), affordability is a key driver for access in many low- and middle-income countries.
Therefore, companies are expected to make commitments and develop strategies to price their pro-
ducts equitably within and between countries, in order to ensure prices are affordable for the buyer.
Conceptually converging with the criteria adopted by ATMi and AA, 24 companies mentioned
price as a strategy for access to medicines. Analyzing the results of this category, we found that
52% of the disclosed strategy regarding price refers to the application of lower prices in developed
or low-income countries (LICs) which, in addition to useful advertisement, is also an important
strategy for entering a new market and/or becoming more competitive against competitors. How-
ever, despite its importance in terms of access, price alone is not a long-term initiative (Barton,
2002; Wirtz & Moucheraud, 2017; Zapatero Miguel, 2015). On the other hand, 48% of the pricing
strategy refers to the application of lower prices through partnerships with NGOs. By enabling
cheaper medicines through these partnerships, companies increase visibility and their level of com-
mitment to society, therefore making this initiative potentially more robust and sustainable (Doh &
Guay, 2004; Nejati & Ghasemi, 2013; Turker, 2009).

3.4.2. Manufacturing capacity building and filing for marketing approval/registration

_Strategy disclosed by companies: Physical presence in countries and/or through registered
products
If a product is not present in a country where it is needed, it is certainly not possible to talk about
access to medicines. Therefore, for ATM (2017), manufacturing medicines locally can lead to
reduced costs and improved supply. But, in order for products to become available to populations,
they must first be approved for sale by the country’s regulatory authority and drugs tend to be wel-
come in countries where there is a need identified by public health authorities.
Conceptually converging with the criteria adopted by ATMi and AA, 9 companies mentioned that
presence in developing countries was important for access to medicine, either through local factories
(44%) or authorisation to market their products in these countries (56%). Intrinsic to business
expansion objectives, physical presence in countries can be a useful advertisement and considered
sustainable for its long term investment characteristics but, by itself, does not constitute an access
strategy. The presence of factories in new countries may reduce production costs, stimulate the econ-
omy, increase the interface with local government, generate jobs and even foster the exchange of
technological knowledge, but a product available on the market (produced or registered) does not
necessarily mean that it will be more affordable.

3.5. Category: Research and development

3.5.1. Product Development _ Strategy disclosed by companies: Partnerships for Productive
Development (PDPs)
A PDP is a collaborative partnership between the industry and the public sector that results in pro-
ducts focused on diseases from developing countries for which market incentives are insufficient. We
frame this type of partnership, reported by companies as an ATMi’s ‘Product Development’ strategy,
because it is expected that ‘companies will develop and adapt products that meet public health needs
786 M. D. M. ROCHA ET AL.

and are suitable for people living in countries within the scope of the Index’ as part of this strategy
(ATM, 2017, p. 38).
In this case, 16 companies reported being involved in PDP with NGOs (such as Drugs for Neg-
lected Diseases Initiative (DNDi) and Medicines for Malaria Venture (MMV)) or philanthropic
funding agencies (such as the Bill & Melinda Gates Foundation and Wellcome Trust) to reach
and expand markets in developing or extremely poor countries. In general, PDPs are not only useful
advertisements but can also be considered robust partnership strategies for access to medicines as
they can involve global experts, national policy makers, providers, and end-users. They also pool
public sector funding, private-sector pharmaceutical know-how, and their respective strengths to
mitigate market and development risks while creating sustainable medicines (Moran, Guzman,
Ropars, & Illmer, 2010; Williams, 2012).

3.5.2. Clinical trial conduct _ Strategy disclosed by companies: Clinical study and expanded
access programme
For ATMi (2017), strict adherence to globally agreed clinical trial standards helps to ensure the ethi-
cal treatment of clinical trial participants. Enforcement mechanisms for ethical clinical trial conduct
are weaker in low- and middle-income countries, raising the expectation that companies publicly
commit to adhering to globally agreed standards for all trials. In turn, companies must ensure clinical
trials are conducted ethically and in compliance with high standards practices; they are expected to
adhere to Good Clinical Practice guidelines and comply with the Declaration of Helsinki. The ATMi
will interpret a breach of codes of conduct as an indication that clinical trials are being poorly man-
aged. Companies are expected to have transparent policies in place to ensure post-trial access to
treatments tested in clinical trials in Index countries. Although included in an access index and
also mentioned by 3 companies, clinical studies are intrinsic to the activities of pharma companies
that want to increase their portfolio and thus are not sustainable due to their short-term character-
istics, as studies terminate after obtaining the required data for marketing authorisation. Similarly,
while expanded access programmes (mentioned by 2 companies) favour a slightly larger number of
people, the initiative’s temporary feature remains until the Competent Authority approves the pro-
duct. Therefore, these strategies could only be considered as access strategies and sustainable if the
patient could maintain their treatment after the product is on the market.

3.6. Other categories

3.6.1. Strategy disclosed by companies: Patient Support Program (PSP)
PSPs combine features of the previously discussed pricing and education strategies. Financial assist-
ance actions, discounts, loyalty programmes and coupons, usually performed through these pro-
grammes, are punctual actions, usually temporary and, therefore, not sustainable because they
provide short-term savings but increase long-term health costs (Ganguli, Clewell, & Shillington,
2016). In the WHO’s view, PSPs also increase the likelihood that patients will develop a sense of loy-
alty to a branded product that may diminish the physician’s willingness to prescribe a generic equiv-
alent, increasing the chance that insurers will increase the coverage rates of all patients to compensate
for increased medicine spending (Ross & Kesselheim, 2013). This strategy is not on the criteria list
for ATMi and AA access programmes, although 12 companies in the name of access to medicines
used it as a useful advertisement.

4. Conclusion
Access to medicines is part of health promotion and has been increasingly prominent on the agenda
of pharmaceutical companies, not only in the sphere of social responsibility but also, and especially,
in the business arena. The present study critically evaluated and rated how 44 pharmaceutical com-
panies that innovate in medicine are publicly positioning themselves regarding access to medicines.
 GLOBAL PUBLIC HEALTH 787

We also analysed if these initiatives are aligned to existing access programmes and, especially,
whether the actions disclosed on behalf of access are sustainable.
Among the 13 major strategies identified (and their variations), there were basically 3 types of
approaches used by companies in the name of access to medicines: (1) Intrinsic actions, which
are initiatives inherent to the pharmaceutical industry to maintain and/or expand its business; (2)
Potentially sustainable actions, which are initiatives that have the potential to make a significant con-
tribution to access to medicines, but can become fickle and short-term if they are not aligned with
other access actions or even government programmes; (3) Robust actions, which are initiatives that
have a relevant contribution to access, as well as being longer term, and therefore more sustainable.
Access to medicines is the result of a complex process that involves diverse actors and public pol-
icies, and is also closely intertwined with the social responsibility of organisations. For this reason, as
verified by this study, the term ‘access to medicine’ has been overvalued by companies aligned with
the values supported by ATMi and AA programmes, both of which encourage strategies related to
sustainability. This overvaluation, however, of the term can generate actions focused on advertise-
ments rather than sustainable long-term actions. To align these two actions in order to create initiat-
ives herein classified as ‘robust’, it is required the construction of clear criteria in global guidelines
that can be extended to governments to apply to all companies and programmes that want to pub-
licise access to medicines as a social responsibility strategy.

Disclosure statement
No potential conflict of interest was reported by the author(s).

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