عنوان انگلیسی مقاله:
The accessibility of data on environmental risk assessment of pharmaceuticals : are environmental risk assessments information on emissions with respect to international and European environmental information law?
ترجمه فارسی عنوان مقاله:
دسترسی به داده ها و ارزیابی ریسک محیطی داروها :آیا اطلاعات مربوط به ارزیابی ریسک محیط زیست درباره انتشار گازهای گلخانه ای با توجه به قوانین بین المللی و اروپایی اطلاعات زیست محیطی است؟
Sciencedirect - Elsevier - Regulatory Toxicology and Pharmacology, 111 (2020) 104571: doi:10:1016/j:yrtph:2019:104571
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
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.
Keywords: Pharmaceuticals | Emission | Access to environmental information | Aarhus convention | Environmental risk assessment