The Animal Experimentation Law

FACTSHEET

While the Animal Protection Law at least attempts to promote animal welfare, the Animal Experimentation Law appears mainly to protect the interests of the bio-medical industry in Israel. Indeed, the aim of the Law from its inception was to regulate, not restrict, animal experimentation.

Under the Law, each research institute (universities, pharmaceutical companies, and others) may establish an internal committee that can authorize this institute to conduct specific animal experiments. In most European countries, the body authorized to grant permits for specific animal experiments is external, for example a government agency or public committee. Even in the U.S., from which the model of internal committees was copied, the law specifically requires that each internal committee include an external member not connected with the institute. In Israel, no requirement mandates including a representative of the public on internal committees. The entire process by which animal experiments are approved is conducted behind closed doors, with no public accountability.

The internal committees are overseen by the National Council for Animal Experimentation. The Council, which has the authority to prohibit animal use where a "reasonable alternative" exists, consists of 23 members, only three of whom are representatives of animal welfare organizations. Most Council members are representatives of universities and drug companies that conduct animal research and of government agencies heavily involved in the practice, such as the Ministries of Health and Science. The Council employs one part-time veterinarian to inspect all research animal facilities throughout Israel.

It is therefore not surprising that the Council has done little to guarantee protection to animals in laboratories. Even though the Law specifically ordered the Council to issue regulations within six months of its establishment (clause 24), it was only in 2001 — seven years after Council members were appointed — that regulations were published. This came only after the Supreme Court ordered the Council to do so.

To date, the Council has not approved a single alternative to animal use. Even specific replacement alternatives approved in the U.S. (for example, the LAL test as an alternative to the rabbit pyrogenicity test in which live rabbits are used to determine whether injectable drugs/solutions will cause an increase in body temperature or not) or in Europe (several dermal toxicity tests approved by the EU) were rejected by the Council in Israel.

With the exception of cosmetics and household products, the law does not ban a single type of animal use.

Despite its detailed nature, the Animal Experimentation Law does not explicitly ban a single type of animal experiment, with the exception of animal tests for non-medicinal cosmetics and household cleaning products. In its original form of 1994, the Law didn't even ban cosmetics and household product testing. It was only through the private initiative of several Knesset members, and despite the objection of the National Council for Animal Experiments, that in May 2007 the Israeli parliament decided to amend the Law and to completely ban "animal testing of non-medicinal cosmetics and of household cleaning products." In addition, in January 2013, the government announced that "Israel will no longer allow the import and sale of cosmetics, toiletries, or detergents that were tested on animals."

The Animal Experimentation Law doesn't regulate the licensing of cosmetics and doesn't set standards. It only regulates animal experiments. The newer law that allegedly prohibits the import of cosmetics tested on animals in other countries is amendment #18 of the Pharmacists Ordinance, which passed in 2010. It says that after the end of December 2012 (two years after the law was passed), no one will market in Israel cosmetics that were tested on animals, but they could still market cosmetics tested on animals until January 2014 if there is no validated alternative to animal testing of this type or of this cosmetic product. The Minister of Health, with the approval of the Knesset Education Committee, could postpone this date further, so that even after 2014, cosmetics tested on animals could still be marketed in Israel.

Even where alternatives exist, the Ministry of Health could allow the marketing of cosmetics tested on animals if the Ministry believes that without such testing, consumer safety could be at risk.

The law refers both to final products and to ingredients.

The Pharmacy Department within the Ministry of Health is responsible for licensing all cosmetics in Israel. It is illegal to market any cosmetic product without a license from this department. They set their own requirements and standards for the safety testing of new products. In general, they don't require new products to be tested on animals if they contain known ingredients which have either been tested on animals in the past or which are considered safe for human use. However, like most, if not all, regulatory agencies in the world, when new ingredients are included in a new product, the Pharmacy Department demands, as a condition for licensing the product, that the new ingredient undergo several types of animal tests. In the past, their requirements included acute oral toxicity tests (not necessarily the LD-50, but some type of acute toxicity test), eye irritancy tests (Draize or something similar) and dermal toxicity tests.

Since the specific requirements of the Pharmacy Department are not published but are part of the internal procedures of the department, they are not defined in any legislation and are not known to the public. A Freedom of Information Act request would have to be submitted to obtain them unless the Ministry of Health does not wish to disclose the information.

It still remains to be seen how the ban on import is going to be implemented and whether the Ministry of Health will use its authority in the law to allow cosmetics that were tested or contain ingredients that were tested on animals after 1 January 2013 to be imported into Israel or not. This is certainly not clear at the moment, and despite the huge loopholes in the law, it could be implemented strictly if the Ministry of Health decides to do so.

With respect to other types of animal use, clause 9 of the Law states that an animal experiment will not be allowed if the purpose of the experiment can be achieved by "reasonable alternative methods," but it fails to define "reasonable."

Partial protocols of the National Council for Animal Experimentation show that the Council adopted a narrow definition of "reasonable," a scientifically valid alternative that is economically viable and that is accepted in every other country of the world. In one protocol, Council members expressed their concern over approving even the well-established LAL test, approved in both the U.S. and Europe – since China still requires the rabbit pyrogenicity test and does not accept the alternative.

Other clauses of the Law are not less ambiguous. For example, clause 1 in the Appendix prohibits the use of neuromuscular blocking agents (which cause paralysis but do not block pain) without general or local anesthesia or analgesia, but adds that use of muscle relaxants without anesthetics could be allowed when the use of anesthesia defeats the purpose of the experiment.

Conclusion

The Animal Experimentation Law appears to protect the interests of the large bio-medical industry, rather than safeguard animal welfare. Since the Law was enacted, animal researchers have repeatedly claimed that now that their activities are closely monitored and regulated, the public has no reason for concern. The Law has become a tool that allows animal experimenters to reject demands for public accountability.

Clause 22 of the Law bans disclosure of any documents pertaining to animal experimentation without the prior approval, in writing, of the Chairman of the Council (a representative of one of the universities). This clause has enabled animal researchers to increase the secrecy surrounding animal experimentation in Israel. Hundreds of thousands of vertebrates suffer and die in Israeli laboratories each year, but the public, which funds most of the experiments through its taxes, is not allowed even basic information as to the fate of these animals.