Code of Ethics
AseBio’s Fundamental Ethical Values
AseBio, the Spanish Bioindustry Association, is an association of businesses that represents the Spanish biotechnology sector. Our members are small, medium and large companies; research centres, universities and hospitals; technology parks and centres, and scientific associations, foundations and societies that work in research, development, trials, production, marketing, distribution and sales of healthcare products and services in the fields of healthcare, agriculture, chemistry, food and the environment.
AseBio’s fundamental mission is to foster development of an innovative, dynamic, biotechnology-based industry in Spain.
AseBio advocates a legal, regulatory and supervisory environment based on scientific criteria that is transparent and consistent.
At AseBio, we have made it our responsibility to address society’s ethical concerns and use dialogue to foster mutual understanding around those concerns, including ones based on cultural or religious issues.
This Code of Ethics is for any stakeholders interested in the biotechnology sector who would like to know more about the basic ethical values that underpin our work. All AseBio members share these fundamental ethical values.
Due to the innovative nature of biotechnology and how fast new technology develops, and because society’s priorities change over time, these fundamental ethical values may be updated to cover new topics and knowledge that arise in the future.
We are committed to socially responsible use of biotechnology to improve quality of life, by preventing, diagnosing, treating and curing diseases; to boost the quality and quantity of food available; to make sustainable materials and chemical products; and to protect the environment and remediate hazardous waste.
We are committed to meeting demanding ethical standards in developing and using safe, effective products.
We develop and use biotechnology with the utmost respect for human rights and dignity, taking steps to prevent inappropriate use of our technology.
We prioritise health, safety and environmental protection in our research, development and manufacturing activities, as well as in distributing our products and services.
We communicate and share pertinent information on biotechnology and the products and services derived from it in a precise, balanced way, explaining both the rewards and the risks.
We are open to inclusive, informed dialogue with any stakeholders interested in the ethical, social, environmental, financial, regulatory or legal aspects of biotechnology and its applications.
We are committed to raising awareness of biotechnology among all stakeholders involved, including general society.
We are in favour of providing precise, transparent information on biotechnology-based products, avoiding any information that is irrelevant or confusing, to allow consumers to make an informed decision.
We are committed to replacing, reducing and refining animal testing (the 3Rs principal), developing and promoting alternatives geared towards reaching high animal-welfare standards. We are committed to minimising the pain and discomfort in animal testing and to using animals only when scientifically necessary or required by applicable regulations.
We support the ban on development, production and storage of biological weapons promoted by the Biological Weapons Convention and we will not take part in research or any other activities used to develop, test or produce these weapons (United Nations).
We support the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, also known as the Oviedo Convention (Council of Europe).
We support the Universal Declaration on the Human Genome and Human Rights (UNESCO).
We support the protection of intellectual and industrial property for products obtained using biotechnology and we advocate making industrial property protection compatible with protection of the rights of other stakeholders, like those in less-developed countries.
We respect healthcare professionals’ codes of ethics and their independence in making medical decisions regarding diagnoses, prescriptions and the use of any products or care services for patients.
We are committed to having transparent relationships with patients and patients’ groups and to safeguarding and respecting their independence.
We respect people’s privacy and support protections to ensure medical and genetic information is kept confidential.
We are opposed to using or disseminating medical information that could lead to intolerance, exclusion, stigmatisation or discrimination.
We make sure, as far as possible, that informed consent is obtained from any individuals that participate in our clinical research programmes, in line with current regulations. When the individuals are not able to give consent themselves, we will get it from their legal representatives.
We recognise and support the position that serious rare diseases, as well as neglected diseases, are a public health priority and we take our shared responsibilities in these areas seriously.
We do not use or support the use of cloning technology for human reproduction.
We subscribe to the conclusions of the International Summit on Human Gene Editing, of December 2015, specifically those regarding clinical use of germline editing. We believe it would be irresponsible to use germline editing for clinical purposes until there is a wider social consensus on this issue. Additionally, clinical use of germline editing should be supervised by the pertinent regulatory authorities and be reconsidered as science advances and social perception evolves.
We are committed to ethical research with different types of cells. We support cell research to advance biomedical knowledge and its medical applications within the current legal and ethical framework.
We support compensation for human tissue donors, to offset their time and expenses.
Conflicts of interest (perceived or real, for people or organisations) may arise when a person or organisation has multiple interests, some of which could affect the integrity of their actions. When they can’t be avoided, we advocate that these conflicts be revealed early and effective decisions be made at a higher level to ensure they are properly handled and resolved. In any case, conflicts of interest must not compromise patient or client safety and wellbeing, or data integrity.
We support publishing information on clinical trials and making their conclusions available to the public, regardless of the results, so clinical trials aren’t repeated unnecessarily. The information published must protect patients’ privacy and be done in a way that does not infringe on confidential business information.
We support patients’ access to pertinent information and genetic advising before and after genetic analyses.
We do not believe in the use of pharmaceutical products to improve sports performance.
Healthcare professionals and patients (or their representatives) may, in good faith, act as consultants to AseBio and its member companies, providing valuable consulting services for research, participating in advisory boards and making presentations at events promoted by AseBio.
We believe it is appropriate for healthcare professionals who provide these services to be reasonably compensated. The compensation should be fitting of the services provided and based on the nature of the services, as well as meeting all applicable legal and fiscal obligations. Furthermore, AseBio and its members can cover any reasonable expenses consultants have in carrying out the consulting services. We subscribe to the principles in the international declarations listed below:
> Declaration of Helsinki - Ethical principles for medical research involving human subjects (World Medical Association)
>Universal Declaration on Bioethics and Human Rights and its Additional Protocols (UNESCO)
Agriculture, Human and Animal Nutrition, Fibers, Chemical Products, Materials, Fuels and Bioeconomy
We support work to improve the quality, quantity and accessibility of agricultural products, in order to make the human and animal food supply chain more secure. We also support improvements to raw materials like fibres and renewable energy sources based on agricultural production.
We promote efficiency and sustainability in the primary sector, using biotechnology in agricultural production and farming (including aquatic species).
We support development of a wide range of biotechnologies, including the use of transgenic and native gene-editing techniques, which have substantial benefits for all sectors of biotechnology. In the agriculture sector, these technologies give farmers more opportunities to protect and make their crops and livestock more productive, using natural resources more efficiently.
We believe it is necessary to harmonise regulations and administrative processes worldwide, both for local growing of biotechnology-based crops and for the global sale of agricultural raw materials.
We are committed to having transparent relationships with farmers, distributors of agricultural raw materials, food processing companies, retail shops and consumers. Our goal is to make them aware that green biotechnology is safe and has many advantages.
We support sustainable use of plant materials and by-products to make bioproducts (chemical products, materials and fuel) to develop a sustainable bioeconomy.
We support development of cleaner industrial processes and urban waste management, using biotechnology.
We subscribe to the principles of the UN Convention on Biological Diversity, including those on access and sharing of benefits.
All AseBio members adhere voluntarily to these fundamental ethical values. Member companies are not allowed to present any stance on an issue or opinion as that of AseBio, except when expressly approved by the AseBio Board of Directors.
Member companies give the AseBio Assembly, as requested by the Board of Directors, the power to look into any deviations from these fundamental ethical values and propose suitable actions to correct them.
AseBio staff must subscribe to the principles of the National Commission on Markets and Competition (CNMC) in the Resolution creating the CNMC Register of Stakeholders.
Furthermore, AseBio staff must subscribe to the European Union Code of Conduct for the activities of special interest groups, which is in the Agreement between the European Parliament and the European Commission on the transparency register for organisations and self-employed individuals engaged in EU policy-making and policy implementation. We are committed to basing all of our actions on the principles of transparency, honesty and integrity
Given increasing social awareness and a much more demanding regulatory compliance framework, here at AseBio we want to reaffirm our commitment to transparency and responsibility in our Code of Ethics. So, we have created this communication channel, open to our stakeholders, employees and the general public, to report any behaviour or situations that infringe on current law or any of our fundamental ethical values.
Any reports made through this channel (anonymously or not) will be handled with all due diligence. The AseBio Executive bodies (Board of Directors and Assembly) promise to take any measures necessary to resolve any verified anomalies or improper actions.