In the pharmaceutical sector, the right of access to environmental information is in most cases not feasible as the authorisation holders refer to commercially/industrial confidential information (CCI). However, CCI can not refuse access to environmental risk assessments (ERAs) if ERAs are to be classified as information on emissions. Pharmaceuticals inevitably enter the environment as a consequence of their intended use. This release is calculated in the ERA as predicted environmental concentration when a pharmaceutical is approved. The release of pharmaceuticals into the environment falls consequently under the term 'emissions into the environment'. In addition, the ERAs assessing the risk of this release are to be classified as 'information on emissions into the environment'. Therefore, the practiced secrecy of ERAs of pharmaceuticals and their official assessment reports is incompatible with Art. 4 Aarhus Convention, and the European and national implementing provisions for this article, which require access to such environmental information on emissions for everyone, irrespective of whether they concern CCI. With this legal disclosure obligation of ERAs, there is an enforceable right of access for everyone, which shows the necessity for establishing a publicly accessible database based on active pharmaceutical ingredients with substantiated information on the ERAs.

中文翻译：

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药品环境风险评估数据的可访问性-是否是根据国际和欧洲环境信息法制定的有关排放的环境风险评估信息？

在制药部门，在大多数情况下，获取环境信息的权利是不可行的，因为授权持有人是指商业/工业机密信息（CCI）。但是，如果将ERA归类为排放信息，则CCI不能拒绝获得环境风险评估（ERA）。药物由于其预期用途而不可避免地进入环境。批准药物后，在ERA中将该释放量计算为预测的环境浓度。因此，药物向环境的释放属于术语“向环境的排放”。此外，评估这种释放风险的ERA将归类为“排放到环境中的信息”。所以，药品ERA的实践保密性及其官方评估报告与Art不兼容。4《奥尔胡斯公约》以及本条的欧洲和国家实施规定，要求所有人获取有关排放的此类环境信息，无论其是否涉及CCI。有了ERAs的法律披露义务，每个人都具有可执行的访问权，这表明有必要基于具有ERAs实质性信息的活性药物成分建立可公开访问的数据库。不管他们是否涉及CCI。有了ERAs的法律披露义务，每个人都具有可执行的访问权，这表明有必要基于具有ERAs实质性信息的活性药物成分建立可公开访问的数据库。不管他们是否涉及CCI。有了ERAs的法律披露义务，每个人都具有可执行的访问权，这表明有必要基于具有ERAs实质性信息的活性药物成分建立可公开访问的数据库。