Reach
(Registration, Evaluation, Authorisation and Restriction of Chemicals)

 

Hovione's REACH Pre-Registration Strategy

With regards to all APIs (whether commercial or in clinical development), and currently produced in any Hovione site wherever located, we shall pre-register within the REACH process:
 

provided they are used/isolated/produced in the low hundreds kilos per year. We may exclude from our pre-registration list those products for which our suppliers communicate a commitment, and later confirm, that they have completed their own pre-registration. Hovione has decided that the benefit of pre-registration (delaying registration till 2018 for most of the substances we make, isolate or buy) far outweighs the potential costs of risking not to pre-register and therefore having to stop the use of substances and do the full registration as from 1st December 2008: indeed the lowest cost of registration of any substance is at least €50.000 but more importantly adds a 6 months delay to the critical path in any project involving a non-registered product, which -as is obvious to all- totally cripples any R&D project that moves to >1 ton scale. (For below 1 ton/year the situation is far better now than in the past: to apply for a PPORD (Product and Process Oriented R&D) is expected to take 2 weeks, cost 500 euros, require no special tests and remains valid for 5 to 10 years).

This fact alone will significantly handicap Europe's ability to compete in R&D contracting services, and will promote de-localization of this high value added activity.

In order to limit the damage of REACH to our R&D projects we have decided to upgrade our facilities in Macau, China and in New Jersey to address R&D projects; in addition will be pre-registering all the substances related to our, and our clients', clinical development programs. This means that all substances needed, isolated or that result from our API synthesis and that are currently performed at a few hundred kilos per year will be pre-registered. This applies specifically to specialty products specially made for Hovione, or products that we know not to be widely commercially available or those for which medicines is an atypical use and for this reason are unlikely to be pre-registered for our activities and therefore will not otherwise be available to Hovione post 1st December 2008.

We realise that this will mean that we will have to disclose business critical information that is either Hovione's, or our customers', proprietary information. We are in the process of advising our customers of the impact of REACH to their business and of letting them know what is our proposed solution and strategy. In this context we understand that submissions to ECHA will remain confidential, however all legal entities that pre-registered the same substance will be notified of eachothers' names (this will be called a SIEF = Substance Information Exchange Forum). There will be a SIEF for every substance. All members of each SIEF will know the identification of each other and are expected to share information and collectively finance the preparation of the data (including toxicity studies) for registration. If you do not belong to a SIEF of a product you produce or require, your access to the product will be limited unless someone (with SIEF membership) chooses to sell the product to you.

Hovione's view is that the REACH process is effectively a more favourable environment for the pharma chemicals industry as the annual quantity hurdle has now been raised to 1000kg – and before this was set at 10kg. In addition the level of information required for a new intermediate that grows to be more than a tonne per annum is absolutely minimal (as is the cost) unless it exceeds 1000 tonnes per annum. APIs themselves once approved are excluded from REACH. Our current strategy is one that puts Hovione, and Hovione customers, in a better position that at pre-REACH because we are taking action to making sure that to the extent possible we are able to maximize the windows of opportunity that REACH has made available to us.

Hovione's finds it important to note that this strategy is not inconsistent with our mission statement and our policies, nothing in this strategy corresponds to a weaker protection of the safety of the users of our APIs, the patients, the public at large or the environment. Quite the contrary this strategy will result in a benefit that is the delay by several years, or the complete avoidance, of many toxicity studies and therefore the reduction in the number of testing animals that will be sacrificed. Indeed the majority of the new products we develop usually never make it to the market and ought not to be put through the REACH process.

Our products are very valuable, they are the object of highly controlled shipping and complete traceability, they are handled exclusively by highly trained and competent professionals and the public is never exposed to them. Hovione is on record for several years stating the lack of wisdom of REACH in so far as it aims to regulate regionally a very globalized industry and applies the same regulation to all chemicals (whether they cost little €1-€10/kg (eg salt or cement), to >€15.000/kg as some of our APIs; and all products irrespective of volume: whether made at 10.000 tons per day or at 1 ton per year).

As could be expected no-one knows what this piece of regulation will result in. The ECHA (the EU agency with authority over REACH was recently established in Helsinki) is expecting 30.000 products to be pre-registered. Hovione's view is that this number will be exceeded maybe up to a level of magnitude. Hovione has 25 commercial product and 40 products in clinicial development but we plan to file 1000 substances - (this means that we are filing 40 times more products that ECHA expects). What is certain is that Hovione, its suppliers, and its customers have a tough 5 months ahead.

To our partners located outside Europe we apologise for this European initiative that in our specific field of activity may be difficult to justify, but we ask you to consider that REACH is a much needed regulation especially in areas where chemicals are used by users that are ignorant or have little understanding of chemistry. In addition, for the first time ever, we have pan European legislation which ensures that all EU countries have the same rules and, hopefully, the same enforcement of the rules. REACH is much needed to mend the ways of many industry segments that use chemicals without care, and is genuinely trying to make the use of chemicals safer.

With best regards

Guy Villax
Chief Executive
Hovione 1st June 2008

Email addresses with respect to REACH at Hovione:

	will be used for communications with ECHA and other authorities
	will be used for all communications with SIEFs
	will be used for all REACH related communications with our exclusive customers (not Generic products)
	will be used for all REACH related communications with our suppliers

Links:

   • European Chemicals Agency

   • CEFIC


Articles:

  • Kick Off Time For REACH. Preregistration for chemical regulation program settles in after a few teething problems