January 1, 1970 (Vol. , No. )

Anna Hallersten SFL Regulatory Affairs & Scientific Communication

In this final chapter of a five-part series, find out how personalized medicine could change the doctor-patient relationship and, perhaps, society as a whole.

If personalised medicine is integrated in our healthcare system, the patient’s world changes as well. This has an impact on the relationship between doctor and patient and it requires an investment in health literacy. It also has an impact on society as a whole.

This whitepaper argues that the concept of personalised medicine stands for great hope and excitement, as well as for questions and concerns. We have discussed the challenges in translation, development of routine companion diagnostics and pricing and reimbursing, but there is another challenge: how do we integrate personalised medicine into health practice in such a way, that it will maximize health benefits and minimize harm? This calls for empowered patients and carers, and thus investments in health literacy.

With personalized medicine, patients will become more involved in the decision-making process about their own treatment plan and will take part in the discussion about various therapeutic options. [© mangostock – Fotolia.com]

More Information on People’s Health

Personalised medicine is about dealing with questions that relate to the individual person’s body. What are the characteristics of this individual, such as age, gender, blood type, type of immune system or metabolism? To which diseases is the person susceptible? How is the individual’s body likely to respond to diseases and medication?

The latest scientific developments have now reached a level at which molecular processes and genetic variations can supply better answers to these questions. In other words: personalised medicine can provide much more information about the health of an individual person. Are citizens ready for this? And are healthcare providers prepared to communicate accordingly?

More Information on Treatment Options

It is important to realise that not all patients that will benefit from the personalised medicine concept are patients yet, or will ever be patients, in the traditional meaning of the word. Citizens and patients will be more and more asked to contribute to making treatment decisions.

Personalised prevention will become the key to personalised medicine. A test may, for example, reveal that someone is predisposed to develop a particular disease and thus enable that person to take preventive measures that may stop the disease from ever manifesting itself.

The comfort level with a treatment will increase when the patient can be assured that he or she does not belong to a category that is known to suffer from adverse reactions to that medicine, or to a category for which the medicine is not likely to work (in these cases, the doctor would have prescribed another medicine). Better knowledge, in advance, of the likely side effects of the medicine and their severity, makes it easier for the patient to plan for the treatment and to fit it into his or her daily life.

Impact on Patient-Doctor Relationships

In order to get to know more about the individual’s body and the way it may respond to diseases and medicines, it is often necessary to do some tests. This has several implications.

First of all, patients will become more involved in the decision-making process about their own treatment plan, beginning with a decision on a diagnostic test. A blood test is usually not regarded as inconvenient, but the results may not tell the whole story, while a biopsy, only obtainable under anaesthesia, will probably reveal the underlying problems, but could take several weeks to be analysed.

The patient and the doctor will have to discuss the options and consequences. What might happen if no treatment is administered, while waiting for the test results? What might happen if the medicine is prescribed without determining if it is suitable for the person in question?

Secondly, the patients will take part in the discussion about various therapeutic options. If any predictions can be made about the response to treatment, it will probably be expressed in a success rate. A patient’s interpretation of “chance” is a rather subjective. Some patients will think a 10% chance to respond well to the treatment is a fair chance, while others will not find it worth the discomfort or pain.

The patient will have to be supplied with information about the available personalised treatment options. Therefore, doctors will also have to know what is available and be capable of explaining things clearly to the patient. The doctor’s expertise to analyse test results and put them in perspective, will also be crucial. As has been pointed out by experts, part of the responsibility to improve health literacy lies within the health systems.1

On the other hand, the patient will surely search the internet, looking for a “patient like him or her”, and participate in forums. Patients will be more empowered, better informed and more capable of making choices based on detailed information on their patient profile, in other words: they will be more “health literate”. Moreover, it is to be expected that in the future patients will be able to find the results of clinical trials on the internet, with exact descriptions of the patient profiles based on biomarkers. Individual patients will be able to make a weighted and personal decision on their participation in clinical trials.

Finally, there is increasing availability of home tests which can be used to determine a person’s biological disposition to a wide range of diseases including cancer. It is important to raise awareness about the fact that the presence of a biomarker for cancer does not necessarily mean that you will get cancer. If patients are concerned about the results of such tests, they should always consult a doctor.


The future of medicine such as personalised medicine will be a major development but it raises also new questions. For instance ethical questions. While personalised medicine can identify patients who are likely to respond well to a particular medicine, it also offers the possibility to rule out patients for whom the medicine is not likely to be effective or suitable. What happens if there are no alternatives? Should the person still receive the only medicine available? Even if that medicine is likely to cause severe side effects or even adverse reactions? Moreover, would the medicine still be paid for by healthcare insurance companies?

Diagnostic tools are pivotal for the personalised medicine concept. Therefore biological samples are needed. What happens with the samples and related information that people provide? Who has access to it? Can individuals be identified? Who owns the data? Do employers or insurance companies have access to it? Would a predisposition to a disease influence a person’s chances of employment or health insurance?

These and many more questions require an open dialogue between science, industry, policy and civil society.

Anna Hallersten is public affairs director at SFL Regulatory Affairs & Scientific Communication.

This article first appeared as chapter 5 of a white paper published by the EuropaBio Personalised Medicine Taskforce entitled “Personalised Medicine: Status Quo and Challenges”.

EuropaBio represents 56 corporate members and 14 associate members and BIO regions, and 19 national biotechnology associations who in turn represent some 1800 small and medium sized biotech companies in Europe. Members of EuropaBio are involved in research, development, testing, manufacturing and commercialisation of biotechnology products and processes. Our corporate members have a wide range of activities: human and animal health care, diagnostics, bio-informatics, chemicals, crop protection, agriculture, food and environmental products and services.

1 Kickbusch I and Maag D Health Literacy. In: Kris Heggenhougen and Stella Quah, editors International Encyclopedia of Public Health, Vol 3. San Diego: Academic Press; 2008. pp. 204-211. Academic Press; 2008. pp. 204-211.

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