Patient orientation in pharmaceutical companies - contradiction or condition for innovation and economic success?

First of all, it helps to repeat something that goes without saying: the healthcare system is there for the citizens, especially if they are patients, and not the other way around. Patient-centeredness is therefore the consistent alignment of all actors and their services/contributions as well as processes to the needs of patients1. It cannot be ignored that the term patient-centeredness has been devalued through inflationary use. The authors of this article therefore prefer the term patient orientation. This is the path to a healthcare system that actually aligns its services, including drug supply, with the needs of patients and enables targeted and easy access to these services for patients. The term is also interpreted heterogeneously in the literature.

>> The basis of patient-oriented healthcare is empowerment, which is intended to encourage people to “discover their own strengths and provide them with assistance in acquiring self-determination and life autonomy” (Herringer 2016). Shared decision making is closely linked to this concept, in which patients and doctors make a decision together based on the available collective and patient-specific evidence (Elwyn et al. 2010). Patient-centeredness refers to a focus on the patient's decision, in which the patient's needs are placed before the perspective of the service provider (Charles & Bardes 2012). The most comprehensive concept is patient-centricity. The patient is at the center of the thoughts and actions of those involved in the healthcare system and healthcare is thought and implemented from their perspective (Robbins et al. 2013). The patient can decide within a dynamic process which information, such as: B. medical information, personal preferences, values or views he wants to disclose. The concepts mentioned are based on each other, with patient empowerment forming the basis for further patient-centeredness. However, not all patients are capable of empowerment to a comparable extent and it can therefore be difficult to involve the patient in the care process and the therapy decision. It is repeatedly demanded that patients should have a health literacy that enables them to classify the information offered (Gaissmaier 2011). According to this definition, access to valid health information and the ability to use it effectively are the basis of patient empowerment. However, its success depends on the patient's resources, as he is a key factor as a co-producer of his own health. This is particularly important because a patient's illness can severely limit or reduce their cognitive and social abilities. Actual empowerment at the patient level must therefore be inclusive, i.e. the patient must be empowered to make independent decisions within the scope of his possibilities and in the manner that suits him.
With the increasing digitalization of life, patients are experiencing new opportunities for participation. They are no longer just recipients of information; rather, they can compare and select offers themselves in a more targeted manner and also communicate structured information, for example about their health status or their preferences. In this way, new types of data that are more aligned with the reality of patients (e.g. patient-reported outcomes) can be integrated into the body of evidence for a drug. In this way, the patient's role completely changes from being treated to acting on their own. Digitalization is the main driver of a paradigm shift in healthcare.
Beyond the individual patient-doctor relationship, patient orientation requires the inclusion of patient perspectives at the health system level. For this reason alone, the pharmaceutical industry is in demand here. However, there is currently no widely accepted concept for systematic patient involvement in the pharmaceutical industry (Hoos et al. 2015). However, the fact that patient orientation in all phases from research to product development to marketing should not only be paid lip service, but rather a prerequisite for economic success in the future, is important for pharmaceutical companies, but ultimately also for doctors other service providers and health insurance companies. This does not mean the sole inclusion of patient data in the development process (e.g. in clinical studies) or in the marketing phase (e.g. in pharmacovigilance), because patient data does not guarantee orientation towards the needs relevant to the patient. Rather, the degree of innovation of a product can be measured by its patient benefit. And this in turn can only be determined if the patients' actual problems are identified and suitable approaches to solving them are offered. Patient orientation does not happen by itself. It requires the organization and restructuring of processes in the healthcare system and in the companies themselves. The inclusion of patient perspectives can be done in various ways that are not mutually exclusive, but rather complementary: On the one hand, collective preferences and patient perspectives can be systematically recorded quantitatively and qualitatively and integrated into the research and development process or into patient communication. Secondly, patient expertise in the form of patient advisory boards or expertise panels can be regularly accessed in the form of a co-creation process and made accessible for mutual benefit. It is important to allow those actually affected (this always includes relatives) to have their say. Thirdly, the dialogue with the written self-help and its inclusion is also very useful and necessary.

System perspective
The concept of patient orientation is gradually becoming more concrete at all levels. Systemic (re-)structuring, through the expansion of patients' right to have a say in key decisions, at the legal and regulatory level, potentially means more patient orientation in the healthcare system. With the Statutory Health Insurance Modernization Act (GMG), an institutionalized form of patient participation was introduced in Germany in 2004, whereby patient representatives were granted information, hearing, application and consultation rights on the sub-legal norms of self-administration in the Federal Joint Committee (G-BA). Patients thus take part in decisions that have a direct impact on care structures, processes and quality. Whether this form of patient participation is sufficient or whether it needs to be modified, for example by introducing individual voting rights for patient representatives, is the subject of ongoing health policy discussion. For this purpose, comparisons will also be made with other European countries and with patient participation in European Union institutions, e.g. B. the European Medicines Agency, must be used. Both at the level of the approval of new medicines and in decisions about cost/benefit assessments and reimbursements, in Europe, the USA, Canada and Australia it is no longer just the practice of involving patient representatives, but rather the benefit relevant to the patient is explicitly used as an essential decision criterion used.
A patient-oriented healthcare system is economically necessary to ensure efficient resource allocation (Porter 2013).
However, the focus of this article is not this institutional, macroeconomic perspective, but rather the consideration of the role of patient orientation for pharmaceutical entrepreneurs at a microeconomic level.

Academic perspective
Health care research is increasingly taking patients' perspectives into account when evaluating health care services. The subject of the discussion is how valid, patient-relevant criteria can be used to evaluate health services that reflect the different needs of different patient groups. A health technology assessment based solely on clinical, so-called “objective” parameters reported by others is increasingly being questioned. Patient representatives in particular are calling for a methodological expansion that gives more space to the preferences and needs reported by patients themselves and better reflects the reality of care. Methodological approaches are currently no longer just discussed purely scientifically, but are already being tested in practice.
Dimensions of patient orientation in
pharmaceutical companies
Patient involvement at all levels – not just in communication
In connection with pharmaceutical companies, “patient work” is often understood to mean exclusively communication with individual patients and with self-help organizations, i.e. patient organizations, self-help organizations and/or self-help groups. This is often the subject of extensive media and political attention. However, patient orientation in a company is to be understood much more broadly, namely the orientation of the company to the needs of patients. Under no circumstances should the patient be misunderstood – or addressed – as the marketing target group.
What is needed is a fundamental cultural reorientation within the company. This can only be successful if patients – like other experts – are actually listened to and included in important decisions and their perspective has a chance to be included, for example in research approaches and the design of clinical studies. It is not enough to carry out “patient work” selectively; rather, a holistic approach is required that enables the systematic integration of the patient perspective. Patient orientation in the pharmaceutical company therefore essentially has five dimensions (Fig. 1).

Strategy & Organization
The patient perspective must be taken into account in the company's strategy and organization. Which patient needs should be satisfied with which products or services and in what form can and will patients be included in all stages of development and marketing? This fundamental leadership task must then also be implemented in the organization and in the target system (Key Performance Indi-
cators). It runs through the entire value chain from research and portfolio management to development and market access to marketing. Last but not least, it requires continuous patient engagement management, which sees itself as responsible for patient orientation (Fig. 2).

Research and portfolio management
It is essential to the company's goals and focus to know patient needs at an early stage, identify potential benefits and provide appropriate solutions for diagnostic and therapeutic problems. This particularly includes determining which diseases the company focuses on and with what goals (e.g. curative, symptomatic, adjuvant). This also applies to decisions to optimize the value of the product portfolio, for example when licensing in or out. Portfolio decisions must address the critical question of the extent to which the drugs in question represent a solution to a specific patient-relevant problem in the future. This applies not only from the perspective of an appropriate supply of medicines to the population, but also from a business perspective. Patient-relevant evidence is increasingly becoming decisive for the price level of a new drug. This is still unusual for some companies: Systematic inclusion of the patient's perspective right from the start is extremely useful, because it is almost impossible to show a patient-relevant benefit later if the basic product concept ignores the patients' actual problems. In particular, patients can also provide important impetus as innovators themselves (see below).

Product development and market access
Patient participation is particularly important in the development of dosage forms, the design and implementation of clinical trials as well as in the approval and benefit assessment phases. In some cases it is even already part of the market access process (e.g. usability tests for drug/device combinations). Last but not least, the presentation of a patient-relevant benefit in the evaluation process, for example in the early benefit assessment in accordance with Section 35a SGB V, is a prerequisite for later market success in Germany. If the proof of additional benefit is already designed and carried out “by the patient” from the outset, the argument in favor of a real innovation is strengthened, not least for patient representatives in the Federal Joint Committee. What is important here is the inclusion of personally affected people as patients or relatives in order to also take into account those benefit dimensions that are not yet sufficiently addressed. This applies, for example, to oral liquids as a new formulation of medicines that were previously only available in solid dosage forms for diseases that are associated with severe swallowing difficulties.
The widespread use of mobile devices among patients offers the opportunity to identify and realistically record patient-reported outcome criteria (PRO). These can be collected both in conventional study settings, especially randomized controlled trials (RCT), but also in “real-world settings”. In this way, the body of evidence can be strengthened especially when product modifications, e.g. changes in the dosage form or the frequency of administration or the fixed combination of drugs in complex pharmacotherapy, have an influence on long-term therapy adherence and long-term outcome, but this has not yet been proven in a practical way could be. The relevant data protection regulations for personal data must of course be observed. Anonymized data on the effects of therapies and disease progression as well as patient preferences offer an opportunity to optimize therapies and tailor them to individual patient groups. In addition, they are the basis for the research and development of new diagnostic procedures and medicines. In this context, it is important to include patients in studies much earlier in the future. Examples show that this can be achieved with the question and design of the studies (Nourissier 2015; Reimann 2015). A study design that is acceptable to patients is important not only for the significance of the study, but also for the speed of recruitment, whether the study remains in accordance with the protocol and ultimately the time until market entry.

Services and service design
More and more pharmaceutical companies are realizing that, in addition to the “hardware” of the product itself, it is necessary to offer services related to the drug in order to make its use safer, more effective and more patient-friendly. This can range from pure information about the disease, to assistance in coping with illness-related restrictions, to patient support programs that facilitate the use of the drug by third parties, e.g. E.g. home therapy providers. Additional medical technology products that are offered for a fee can also be included in these services, which are often summarized under the trendy term “beyond-the-pill services”. What these services have in common is that they will only have a patient impact if they represent solutions to real problems. This can be achieved if there has been a thorough discussion of the patient's needs in relation to the medicine. This requires a good knowledge of patient journeys (treatment paths) and different patient typologies. All of this cannot be done without patients, but can only be worked out systematically together with patients.
communication
Communicating with patients is a great opportunity for companies, not only to pass on information, but also to obtain important information. A distinction must be made between communication with individual patients or relatives and communication with patient organizations (Fig. 3). The dialogue should be conducted “on an equal footing”, which includes mutual respect, a willingness to listen and the honest participation of patients in all phases of the value chain. The special challenges must not be overlooked: it is not easy to correctly classify patient expertise. Are these generalizable statements or are they specific points of view? Are the views expressed representative of a specific patient group or more anecdotal? Is the dialogue fair and balanced or does it offer starting points for endangering the reputation of the company and the patients involved? However, there are solutions to these challenges. It is precisely through the right mix of different approaches, e.g. conversations with written self-help, systematic surveys, e-patient panels, patient advisory boards, social media analyses, etc., that it is possible to achieve a diverse yet systematic view of patients gain and receive relevant, “hard” input for your own company.
In this way, pharmaceutical companies can – albeit in cooperation with other stakeholders, especially patient organizations – make an important contribution to ensuring that patients receive quality-assured, reliable and validated information through access that is as barrier-free and low-threshold as possible.
Implementation of patient orientation
pharmaceutical companies
Results of a survey of BPI members
A survey conducted in January and February 2016 among member companies of the Federal Association of the Pharmaceutical Industry (BPI) eV dealt with the implementation and anchoring of patient-oriented measures in the company.
27 participants took part. The main motive for setting up a special function for patient issues in the company was the optimization of products and services (1.60 ± 0.82). In contrast, sales interest (average rank 2.56 ± 1.00) or increasing reputation (2.44 ± 1.00) were only of secondary importance. Another priority was improving communication with patients and self-help (1.68 ± 0.80). This is consistent with the fact that gaining knowledge about the needs of patients ranks far higher in importance than other topics (1.40 ± 0.68) , which should be dedicated to special patient functions in the company. With this more intensive patient communication, companies want to address both individual patients and patient organizations or groups of patients. To date, companies have primarily used online communication methods such as brochures and information catalogs as well as personal, individual contact with patients. Less established are patient programs or events where companies systematically and regularly exchange information directly with patients.
In view of the great importance that will be attached to patient work in the future, it is striking that at the time of the survey, 70 % of the participating companies did not yet have a separate function (“patient representative”, “patient officer”, “patient manager” or similar). who dealt exclusively or primarily with patient concerns inside and outside the company. Such a position has already been established at the other companies. These are mainly recent developments (Fig. 4).
The position of the patient function is anchored very differently in the organizational chart: it is assigned roughly equally to the management, the areas of public affairs, corporate affairs or market access. Marketing was not mentioned. Many companies consider this to be unsuitable for credibly representing patient concerns within the company. Many companies consciously maintain a clear separation between access to patients and functions of marketing medicines.
The survey conducted by the BPI together with “admedicum” shows that the foundations for increased patient orientation have already been laid in some companies in the pharmaceutical industry. There is still potential on the way to their credible and sustainable implementation. Many companies are still at the beginning or are on the way to tackling the issue of patient orientation in the future. Patient work must be practiced actively and continuously in order to identify patient needs in a targeted manner and to successfully satisfy them in the long term. The prerequisite for the consistent implementation of patient orientation is the adoption of this guiding principle into the corporate culture, processes, goals and personnel structures. There needs to be a binding responsibility in companies for the important work of patient orientation. Patient engagement managers or patient representatives who establish and maintain a systematic, effective and continuous exchange with patients, patient groups and/or patient organizations are central to ensuring that patient orientation does not remain a theoretical concept. Going this route requires careful planning and time at the same time.

Risks and side effects of patient orientation
What risks are there for companies that embark on the path of patient orientation? Aren’t they exposing themselves to possible criticism of “buying patients” or merely paying “lip service”? Relations with patients and self-help written by the industry are always under special scrutiny, which is why it is essential to be guided by the principles of mutual respect, transparency and respect for the independence of the patient side. The relevant codes of the pharmaceutical industry (in Germany: FSA2, AKG3) for the company side and the “Guidelines for cooperation between self-help and commercial companies in the healthcare sector”4 for the patient side provide a good basis for legally compliant interaction between both sides. Any serious and honest approach to anchoring patient-centeredness in pharmaceutical companies should be based on the principles laid down there. Ignoring them harms both companies and self-help, whose greatest asset is a credible mandate. However, for a sustainable, credible relationship between pharmaceutical companies and patients and patient organizations that is beneficial for everyone involved, more than a codification of do's and don'ts is needed. What is needed are guidelines for good patient engagement practice that are based on the principles of a sustainable, respectful partnership, careful listening and fair involvement. Efforts are currently underway to create such guidelines in a multi-stakeholder process.
Patient orientation as a competitive advantage
Patients as innovators – patient needs as drivers of innovation
Patients and their relatives are often experts in their own illness, especially when they live chronically with an illness. Missing or inadequate supply options sometimes force them to find their own solutions. Attentive listening and understanding of unmet patient needs can become a source of innovative developments. More and more, patient organizations, especially in the USA (e.g. in cancer, dementia, Parkinson's, cystic fibrosis, Duchenne muscular dystrophy and other rare diseases), but also in Europe, are becoming innovators themselves and converting promising findings from basic research into a systematic approach to transfer development. Continuing this later requires experienced pharmaceutical partners. This not only creates opportunities for pharmaceutical companies to develop and later market new therapeutic options. Furthermore, insufficient adherence to therapy or a lack of tangible benefit of existing products can be a starting point for pharmaceutical companies for product modifications or “beyond-the-pill” services. Pharmaceutical companies that consistently focus on the needs of patients and thus rethink traditional product orientation can be better able to achieve sustainable patient benefits. Such patient benefit can be achieved, for example, by satisfying the need for a dosage form that is easier to take and that better meets the individual health status of the patient. A completely different question, however, is whether this benefit can then also be represented as a patient-relevant additional benefit within the meaning of the Federal Joint Committee's rules of procedure, for example through an improvement in quality of life.

Improving productivity
Working to improve the lives of people living with a serious illness is a strong motivating factor for employees in the pharmaceutical industry. If they experience that their own company not only communicates this, but lives it in all areas and that patient benefits are actually the focus of the company, this has an impact on the motivation of the individual employees in the company itself and ultimately also on their loyalty to the employer its attractiveness and the productivity of its employees. Companies that succeed in inspiring their employees and their investors beyond financial incentives are more successful than their competitors (McGregor 2015).

Increase in value of the product portfolio
Pharmaceutical entrepreneurs must be financially successful in the long term. You should also communicate this fact openly. This is the only way they can generate added value for their investors, their employees, their customers and the community. Sufficient funding is required to address the development of new diagnostic or therapeutic options. A product profile tailored to the needs of patients and an evidence-based benefit that can be experienced by the patient are essential in order to achieve a strategically favorable starting position
e.g. in pricing and reimbursement negotiations. Patient-oriented clinical development enables recruitment goals for clinical studies to be met and thus potentially shortens the time to market entry. However, these factors have a direct impact on the capital value (net present value) of the product portfolio and thus on the company value itself.

Increasing reputation
Ultimately, a company policy that is consistently geared to the needs of patients is beneficial for the company's reputation among patients and relatives, doctors and hospitals and, last but not least, health insurance companies. This reputation can make the crucial difference, especially in price negotiations and with decision-makers in the healthcare sector. However, the prerequisite is that companies do not impose patient orientation on themselves like a masquerade only to forget it at the first opportunity, but that it is actually lived in a credible manner.
Basis of patient orientation: understanding and implementing patient needs
However, an indispensable prerequisite for the above-mentioned implementation of patient orientation within the company is to first know what patients want. It is the question of their needs, wants, priorities and preferences. This is increasingly being recognized in the pharmaceutical industry. The Federal Association of the Pharmaceutical Industry (BPI) eV attached great importance to this question in its most recent position paper on patient orientation5.
But how to identify patient needs? How to “think from the perspective of the patient”? And how can products and services be optimized based on the insights gained? What is essential here is the holistic perception of the patient as a consumer who uses, chooses and finances, as an object of the care process, but also as a co-producer with individual health and illness behavior, with subjective wishes and expectations (cf. Grande 2014). Instead of talking about the patient exclusively with third parties, such as doctors and experts, the – actually self-evident – fact is increasingly being recognized that it makes far more sense to talk to the patients themselves. Scientifically based methods (qualitative and quantitative surveys, conjoint analyses, mixed methods approaches) are available for this (Mühlbacher 2015). Integration and transparent and fair dialogue with self-help are also necessary. However, it cannot be overlooked that the level of organization of self-help varies greatly in the individual indication areas. While in individual rare diseases (e.g. cystic fibrosis) very high self-help participation is achieved (sometimes well over 50 % of prevalent patients or their relatives), this is not the case with common diseases. Only around 0.8 % of all diabetics in Germany are members of a self-help organization. “Communicating with patients” is therefore not the same as the always necessary dialogue with the written self-help. Rather, patient perspectives must also be accessed outside of written structures and integrated into the work of pharmaceutical companies. Spontaneous statements from patients on social media or other Internet-based forms of communication (forums, chat rooms, etc.) are becoming increasingly important. While patients' unmet needs are very clearly articulated here and these media therefore represent a valuable source of information, pharmaceutical companies must ensure that they always adhere to the basic rules of transparency and respect. Finally, adequate processes for detecting pharmacovigilance signals and their adequate processing must also be in place.6 Last but not least, patient advisory boards or patient ambassadors also offer the opportunity to communicate with specific contact persons “offline” or “online” in the form of e-patient panels questions to discuss.
The pharmaceutical company must ask itself in which “orbit” it moves around the patient (Fig. 5). It is not the size of the company and its material resources that are crucial, but rather the ability to systematically open up to the experiences, opinions and needs of patients.
Conclusion
The healthcare system of the future sees the patient at the center of everything and talks to them and not about them, thereby really involving them. Above all, however, patients are increasingly demanding this and, not least through digital options, are practicing patient orientation without being asked to do so. Patients become an active part of an innovative care system in which patient orientation, participatory decision-making and an open dialogue between stakeholders are demanded, promoted and practiced. Here, everyone involved communicates with each other on an equal level, trustingly and transparently, aware of sometimes conflicting interests, while respecting sovereignty and independence. Turning this vision into reality requires patience, respect and a sustainable economic basis. For pharmaceutical companies, consistent patient orientation offers a great opportunity to offer products and services that have real patient benefit and thus provide an advantage over competitors who do not do this. However, the best possible satisfaction of patient needs is increasingly becoming a prerequisite for remaining in the market. It is therefore the central strategic task of a pharmaceutical company. Not tomorrow, but today. <<