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Comment: Test methods and IP: do we need more transparency from the administrators?

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Many readers may be unaware that many toxicity test methods for industrial chemicals are not free, and users have to pay to use them.

The reason they aren’t free is they contain elements that are protected by intellectual property (IP) rights.

It wasn’t always like this. Go back a couple of decades and you would have struggled to find any IP at all within the canon of standard methods.

In the intervening time, however, scientists have developed and validated many new methods and some of these contain so-called protected elements.

This could be because of the higher proportion of in vitro techniques in the newer methods: it might be easier to claim IP rights over a cell line than a mouse strain, for example.

In contrast, the older methods are predominantly in vivo and adapted from methods that were already at the time widely used for safety assessment of pharmaceuticals, cosmetics and pesticides.

Whatever the reason, in terms of IP rights, we’re looking at a different situation today compared with 20 years ago. And this situation has important implications.

Most obviously, it means that we should be aware of any commercial interests when considering what experts say about the validity of test methods.

For example, if an expert says that a particular test method is the most accurate of its type, they may have a financial stake in the use of that test method. If they do, we might expect a slightly higher degree of evidence before accepting their arguments.

It also means that we should expect a high degree of transparency from the authoritative bodies validating methods.

Of these, the OECD is probably the most important. Under a dedicated programme, it supervises the validation of methods and, If satisfied with the results, adopts those methods in the form of test guidelines (TGs).

Adopted TGs are extremely significant because of the OECD’s mutual acceptance of data (MAD) scheme, which requires OECD member states - plus the other countries that signed up - to accept, for regulatory purposes, any data generated according to an adopted TG. They don’t get to pick and choose. If the tester followed the procedure, the member state regulatory authority has to accept the results.So when a TG is adopted, the value of any IP it contains increases.

Unfortunately, among the authoritative bodies validating methods, the OECD is also probably the most opaque.

The steering committee of the TGs programme, the WNT, meets once a year in April to launch new projects, discuss ongoing projects and adopt methods.

A month or so after the meeting, the OECD publishes the annual work plan for the programme, which provides a list of ongoing projects and describes their progress. Also, twice a year, it publishes a newsletter, Chemical Safety and Biosafety News, which is a rich source of administrative information.

However, meeting agendas and minutes are not published, making it hard to know who attended, let alone what they said.

Furthemore, the same is true for the many expert group meetings scattered throughout the rest of the year. Each group is focused on a particular hazard endpoint and provides scientific guidance on development and validation of the methods relating to that endpoint.

Sometimes the meetings are heralded in the OECD’s biannual newsletter Chemical Safety and Biosafety News. But there doesn’t seem to be a public list of who the experts are or their affiliations.

Of course, a lack of transparency does not mean that anything dubious is going on. There are plenty of practical, legal and financial reasons why authoritative bodies may lack transparency. But if they want to convince us that they are committed to handling commercial interests appropriately, they should publicise the advice they are getting and from whom.

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