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Availability and Timing of New Drugs in Israel: Analysis and International Comparison

Whereas the latest data suggest that the number of new chemical entities (NCE) launches worldwide may be on the increase, both recent and longer term data show a decline in the rate of NCE introductions into Israel. In terms of percentage availability, only 30% of NCEs available worldwide during 1978–1987 were introduced in Israel during the same period, compared with 42% for the U.S.A. In both countries there has been a decreasing percentage availability since 1983/84. The percentage availability of commercially significant NCEs was greater (47%) compared to all NCEs introduced in Israel. Whereas in the U.S.A. the lower the therapeutic rating the higher the proportion of NCEs, in Israel the B‐ and C‐rated drugs were equally represented. NCEs with an A‐rating had a similar share of all NCEs (ca 15%) in both countries. The average time lag for NCEs launched worldwide to reach Israel during 1978–1987 was 4 to 5 years, but in recent years there has been a considerable decline. Commercially significant NCEs introduced in Israel had on average a shorter time lag of 0.5 years than the average for all NCEs introduced. In spite of a preponderance of NCEs first launched in the U.S.A. there was on average a slight relative lag into the U.S.A. compared to Israel. This was probably due to there being a number of NCEs first introduced in Israel with a long delay before they were subsequently approved in the U.S.A. There was an average delay for A‐rated new drugs into the U.S.A. of 7 years compared to their Israeli introduction dates, with half of these top‐rated drugs being available in Israel before they had received NDA approval. The results are discussed in terms of the regulatory process and the influence of prior registration in the U.S.A., U.K. and in other countries. Most NCEs introduced in Israel are marketed or registered beforehand in either the U.S.A. or U.K. or both. In Israel the overseas application lag is usually considerable in relation to the registration lag, which is the opposite to the U.S.A. situation. Nevertheless, in cases where there is a clear therapeutic need for a drug in Israel then it appears that the assumed influence of prior U.S.A. and U.K. registration is less of a factor. Furthermore, for NCEs with commercial potential in Israel one can assume a reduced overseas application lag.