RESEARCH-BASED FIRMS HIGHLIGHT ISRAEL'S DRUG APPROVAL LAG
Israeli research-based drugmakers' group Pharma-Israel claims that consumers will benefit from a steady decline in drug approval delays. The group notes that the approval lag for innovative drugs fell from as long as eight years in the early 1990s to roughly two years in 2002.
However, delays are rising again, with the group citing the Ministry of Health's policy of awaiting new drugs until the process has been completed by major regulators such as the FDA. The ministry's evaluation centre is also reported to be in crisis, as the government prepares to privatise many of its services.
Revealingly, Pharma-Israel reports the ministry's target for generic drug approvals as being just 70 days. The group also recommends that approval in Israel be automatic following approval in another "major market" -- a move rejected by government sources. This is unsurprising, as the ministry is itself a major drug purchaser in Israel, and speedy approval over a 90-day period could also tighten a number of regulatory loopholes that greatly benefit the local generics industry.
A recent weakening in patent law in Israel has angered research-based drug firms, with a number of foreign firms threatening to cut their investment in R&D and withdraw from the country. In the meantime, Israel's biotech companies plan to circumvent unfavourable conditions for sensitive data by filing product registrations in developed markets.