ECHA

Companies making chemicals are increasingly marketing them worldwide. Taking into account different regulations and the need to create separate datasets for each market, requires both money and resources. Could there be an easier way? We spoke with representatives of chemical companies and regulators, to find out where we are with the global sharing of data on chemicals.

The aim of the global assessment of chemical datasets is to have consistent hazard and risk profiles for substances. To get there, all the existing data and the validated methods for risk assessment need to be taken into account. “When we speak about datasets of chemicals we are essentially speaking about their hazard and risk assessment,” explains Dr Adriana Jalba, Manager at the European Chemical Industry Council, Cefic.

Dr Brian Richards, Director of the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) at the Australian Government’s Department of Health, agrees that the assessment and quality of data are key elements in global data sharing. “Success is dependent on being able to assess the strengths and weaknesses of different types of data and developing methods to share them appropriately. Regulators need to continue to be able to assess the quality of the information being shared with rigour and transparency”.

Benefits for industry, regulators and society as a whole

Adriana Jalba. Image: Adriana Jalba.

Dr Jalba points out that global data sharing would not only benefit industry, but also regulators and ultimately the whole of society.

Global data sharing has a key role in promoting innovation and competitiveness because it would, for example, allow companies to get their new, innovative products to market faster than they can today. “If you look around, you can see that supply chains today are worldwide interconnected ecosystems, which means that we have a very complex economy,” Dr Jalba says and continues “the global economic environment is increasingly volatile and therefore, it is essential that companies are able to get to market very fast. If you can’t, you may lose your investment”.

It could also help to reduce the costs for compliance both for companies and regulators. Increased efficiency could also bring along other benefits. “By avoiding duplication of work, regulatory agencies can increase their efficiency and effectiveness. This would ultimately reduce the burden on industry and also enhance the public’s ability to access information on chemicals,” Dr Richards points out. As an example, he mentions that NICNAS’ chemicals assessment programme has extensively used international chemical databases to assess over 3 000 chemicals which are already in use in Australia but have not previously been assessed. These assessments can now in turn be used by other agencies and they can also be accessed by industry and the public anywhere in the world.

“Global data sharing could improve risk management decisions, which leads to better human health and brings positive environmental outcomes. It also provides an important way of avoiding unnecessary animal testing,” Dr Richards says. “For society as a whole, economic growth will be a direct benefit,” Dr Jalba adds.

Improved regulatory cooperation needed

Brian Richards. Image: The Commonwealth of Australia.

There are tools that enable global data sharing. For example, in OECD countries, data can be reported using the OECD harmonised templates. This means that the data required are in a similar format to what has already been collected for other purposes. Also, technical hurdles are less of a problem. According to Dr Richards, developments in technological infrastructure have removed many of the traditional boundaries to sharing large amounts of data and it is now easier to communicate and collaborate with each other. “At NICNAS we are considering adopting IUCLID, in part to enable easier sharing of information, such as QSAR (quantitative structure-activity relationships) predictions,” Dr Richards says.

However, there are still issues that need to be solved before global data sharing can become a reality. For example, systematic regulatory cooperation is required so that data generated under one jurisdiction can be completely validated and acknowledged in another. “Data sharing itself has limited value if there is no cooperation between regulators to reduce the existing divergences. We are all aware of the divergences on the approaches we take and on the different regulatory systems. We need more integrated systems for rulemaking and implementation,” Dr Jalba points out.

What about ownership rights?

Perhaps the biggest issue in global data sharing is, however, the protection of the ownership rights of data, particularly for commercially sensitive and confidential information. According to Dr Jalba, companies are willing to share data but before they can do it there needs to be a clear global framework for data sharing and law governing the data, to ensure that ownership rights and intellectual property are protected.

Regulators are well aware of this challenge. “We as regulators need to remain aware of intellectual property ownership and have safeguards and protocols in place when sharing information,” Dr Richards says.

Dr Jalba mentions that there are interesting projects ongoing that could help regulators to identify possible solutions for the challenges of data sharing and data protection. “Korea is implementing a REACH-like regulation and there is a lot of convergence there. In this context, data sharing is extensively discussed with Korean industry. We could use that to understand how the global process for data sharing can be put into place. For me, that could be the pilot project to learn from.”

Call for political leadership

Closer relations between peer regulatory agencies and the increasing harmonisation of data requirements between the regulatory frameworks can bring us closer to successful data sharing at the global level. There needs to be a common understanding of data and the related hazard and risk assessment. Ultimately, there must be an agreement that brings certainty to industry that their ownership rights are protected during the process.

Dr Jalba calls for political will and leadership to make global data sharing a reality. She emphasises that other regulators also need to be engaged with and support the idea. For example, questions of trade in general are central to understanding the bigger picture. “I think we have to go a long way to fix the practicalities in terms of data sharing, but I believe that it is possible and I hope it will happen in the near future,” she concludes.

Interview by Päivi Jokiniemi
Top image: Fotolia
 

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