Workshop 2: Ethical aspects of commercialization and patentability of stem cells and stem cell lines
13-14 March 2006, Lund

Download full workshop report (PDF, 99kb)

Introduction
This workshop, the second in a EuroStemCell series, examined and discussed the ethical issues raised by commercialization and patents on human stem cells and stem cell lines. The theme was not the research and development necessary to obtain and process the stem cell lines stored in the repositories, but rather the focus on ethical aspects.

Working Paper
A working paper was prepared by Kristina Hug in advance of the workshop, based on

• existing surveys of the state of the art concerning current regulation in the member states
• internet searches on new regulations,
• debate articles on the need for regulation or problems in the implementation of existing implementation.

This paper includes information on

• relevant laws (international and national) dealing with commercialization and patentability
• the key ethical and legal questions raised by commercialization and patentability of stem cells and stem cell lines
• institutions worldwide where stem cell lines are kept and can be obtained for research purposes

Download the working paper (PDF, 589kb)

Participants
Some 50 participants attended this workshop. They represented the spectrum of communities interested in or concerned by the decisions made in the area of patenting and commercialization in stem cell research, and included scientists working in the area of stem cell research, lawyers, ethicists, philosophers, as well as the representatives of the European Patent Office, the EMEA (European Medicines Agency) and patients’ organizations.

The key questions
Several EU directives are relevant to commercialization and patentability, including – the Directive on Protection of Biotechnological inventions, the Advanced Therapies Directive as well as Tissue Protection Directive. Many member states have not yet decided on national implementation of the latter, and the outcome is likely to vary a great deal among nations.

• Can Europe afford to have different ethical standards to the US and Asia with regard to commercialisation and patenting of the products of stem cell research?
• What are the alternatives and the implications for European competitiveness?
• How are the criteria of patentability in biotechnology and the morality clause in the patent convention to be understood and interpreted?
• Are there similar clauses in other parts of the world?
• Which are the pros and cons of altruistic donations vs financial incentives?

The discussions
Questions about conditions of patentability and its alternatives and exceptions, in particular the interpretation and application of the morality clause in the European Patent Convention, generated the most discussion. The least controversial issues related to security and safety aspects - the crucial importance of these issues was already clear to participants.

It should be stressed that there was no formal voting about which conclusions the participants agreed on at the workshop. The statements below should therefore be taken only as tentative conclusions that emerge from the contributions and the subsequent discussions. These conclusions have been sorted into two categories
(a) Statements on which there was a general agreement
(b) Statements or questions that were controversial, unclear or needed further debate/research

The conclusions are presented in the form of fairly “naked” statements. Click the heading below to read the workshop’s conclusions on particular topics.

A. COMMERCIALIZATION

THE IMPORTANCE OF A REALISTIC TIME PERSPECTIVE
FINANCING OF RESEARCH
DONATION OF BODY PARTS
PAYMENT OF DONORS
LEGAL UNCERTAINTIES AND EXISTENCE OF REGULATORY GAPS
INFORMED CONSENT
OWNERSHIP OF CELL LINES
SAFETY
FAIR ACCESS
GOVERNANCE

B. PATENTABILITY

PATENTABILITY OF BODY PARTS
REVIEW PROCESS
CRITERIA OF PATENTABILITY
MORALITY CLAUSE
OTHER ETHICAL ISSUES
CLASSIFICATION PROBLEMS
CULTURAL DIVERSITY AND INTERNATIONAL PERSPECTIVES
PUBLIC PERCEPTION OF ES AND “LIFE” PATENTS
BENEFIT SHARING

GENERAL CONCLUSIONS AND RECOMMENDATIONS

Can we, Europeans, afford to have different standards to those in other countries (e.g. Singapore, Japan, Korea, India, China, etc.)? Different ethical standards can create different policies and different research possibilities. There is a price to pay for having different standards (e.g. different standard of living, different standard of human dignity). Can we say “no” to everything and pay the price? But we cannot say “no” and pretend that no price will be paid. It is wrong to misuse the precautionary principle, which is also an ethical standard.

There is a counter-argument to the assumption that higher ethical standards restrict market opportunities. If we look at businesses, we see that their own ethical codes are becoming more stringent. Trust and reputation are the basis of acceptability and acceptability is the basis for market success. If we look at long-distance perspectives instead of short-distance perspectives, it will pay off to have high ethical standards.

Public-private partnerships (e.g. partnerships between pharmaceutical companies and medical research councils) are extremely valuable. In clinical trials, for example, the public feels more comfortable when it is not just the pharmaceutical company that invests the money but the funding is in cooperation with the research council. The public has the right to feel more comfortable, as in this co-funding situation there is no fear that results unfavourable to the pharmaceutical company will not be published.

It is essential that all interested parties, in particular researchers, patient organizations, industry and regulators, work together to provide better health for European citizens. To facilitate achievement of that goal, several key points emerged and were stressed in the discussion

• The temptation to promise too much too early, in terms of research success, was to be resisted.
• Clear division of roles between researchers and business in the process of commercialization was recommended.
• Donations should in principle be altruistic and free of charge - but the question of economic revenue is complex and needs further investigation.
• It was disputed whether the "broad approach" of the EPO is consistent with article 6.
• Inventions based on isolated human embryonic stem cells should be treated like any other invention and should be patentable if the general patent criteria are met.
• Morality and ordre public are difficult to define, particularly in a multicultural Europe.
• There are competing interpretations of the morality clause in different parts of the world.
• Focus should be on the whether the exploitation of an invention is against morality and ordre public, not on how the invention was made.
• It is essential to distinguish between the raw material donated and the inventions made by researchers based on that material.
• Better use could be made of research exemptions or compulsory licences.
• Transparency and openness are necessary to maintain and strengthen public trust in biomedical research.