AETOX - Asociación Española de Toxicología

Inventory of the Spanish Institutions and Scientists Involved in Alternatives to the use of Laboratory Animals (Refinement, Reduction or Replacement)+

Inventory: 15. Final Comments and Future Trends

From the overview outlined in this report, the impressive development that alternative methods have undergone in the last ten years in Spain is evident.

The field has become more structured on the institutional ground but also better shaped in its theoretical and scientific aspects. This kind of development undoubtedly represents a positive step and a reliable reference point ifor figuring out possible future trends and related investments in terms of their financial, professional and political aspects. Several aspects should be taken into consideration:

15.1.- The regulations

Only 2 Spanish regions have been able to implement their legislation according to the legal requirements of Directive 86/609/EEC, translated to Spanish regulations in RD 223/1988, which protects laboratory animals and avoids unnecessary studies. Moreover, the rest of the regional governments should be urged to do so as soon as possible, and to make necessary provisions to assure compliance.

The Spanish Ministry of Agriculture should carry out their obligations, as well as possible, in relation to the control of and information to the Commission about animals used for scientific purposes. Non-registered establishments should not be allowed to perform experiments with animals.

15.2.- The sponsors

The total Spanish investment in R&D in Spain should be increased as soon as possible, from the 0.85 of 1997, to reach at least the European median, now situated at 1.9 % of the Gross Domestic Product.

In Spain there is no fixed amount of investment for alternative methods. The answers given to the the survey questionnaire indicate that there are only a few cases in which Spanish groups were financed by the specific priorities for alternatives. There are many differences in the regional programmes, not only in the amount of investment, but also in terms of priorities.

The present objective and research tasks included in the National Programme of Health were not very useful in promoting alternatives. The reduced scope of the objective within the pharmaceutical research area, limited to new pharmaceuticals, providing no opportunities for institutions working with pesticides, cosmetics, food additives, industrial chemicals, etc, should be much wider. To better stimulate alternative studies, its formulation should prioritize the impact of alternatives on the real world as much as possible, in order to provide more stringent evaluation of the projects.

The bureaucracy related to the national programmes delayed unnecessarily each step, from the presentation of proposals, to approval, and the receipt of funding. For this reason, the projects became obsolete before starting, and the teams lost competitivity.

Private help for investment in Spain should be increased at least by 15 % to reach the European median. Spanish industry should be asked to fund specific grants for alternatives not currently in existence.

All research grants in every scientific area, funded by public or private entities, should require the commitment of the researchers to comply with present legislation about animal protection, including the registration of animal facilities, the preparation of responsible people for performing animal experiments, the prevision of the number of animals to be used, the possibility of causing pain or suffering, alleviation procedures, and the reasons for not using alternative methods if they are available.

15.3.- The promoters

The impressive activities carried out for the promotion and the development of alternative methods in Spain should be encouraged. Different and complementary activities can be promoted by the existing initiatives, including the Spanish Group on Pharmaco-Toxicology in vitro (GEFTIV), the ICLAS/CSIC Working Group on Complementary Methods, the GTEMA- Spanish Group on Alternative Methods, and the Spanish Network for the Development of Alternative Methods (REMA).

The interconnection of scientists by means of internet through the [3ERRES] GTEMA mailing list has been proven to be very useful and should be promoted.

15.4.- The scientists and the institutions

An important increase in alternative approaches within Spanish scientific production has been observed since 1966 in relation to overall international production, although, at present, it is only 2.13 % of the whole. The increase in experimental studies is proportionally more important for the publications using alternative methods, but with some delay in Spain (32 % in contrast to 36 %).

Appropiate preparation of researchers and technicians should be encouraged. FELASA recommendations on the education and training of persons working with laboratory animals should be followed, and the creation of active ethical committees should be promoted.

The administrative rigidity of many institutions, which block the direct contact with the private sector should evolve to more flexible systems, providing opportunities to make industrial collaboration easier.

Although only a minimum part of the laboratories have participated in previous validation studies, most of them are available to participate in future validation programmes.

More than 75 very competitive Spanish groups interested in alternatives have been identified, with more than 339 researchers. With respect to the main area of application, the most potent was clearly toxicology (25 %), followed by biochemistry, molecular biology and cell biology (9 %), monitoring (7%), biology and pharmacology (6 %), etc. Nearly all the 20 disciplines of toxicology are represented in similar manner.

15.5.- The European level

The 5th Framework Programme of the European Community for Research, Technological Development and Demonstration Activities (1998/2002) represents an outstanding challenge for in vitro toxicology, by offering several opportunities on different grounds to promote and consolidate this activity at the European level

An effective connection with ECVAM is necessary for joint European action pro-alternatives. Initiatives such as the Meeting of Representatives of European Entities Responsible for Alternatives should be organized periodically.

Fuente / Source: Guillermo Repetto, Ana del Peso, Manuel Salguero, Manuel Repetto (1999) Inventory of the Spanish Institutions and Scientists Involved in Alternatives to the use of Laboratory Animals (Refinement, Reduction or Replacement) Revista de Toxicología 16: 50-127.