Ethical considerations in the regulation and use of herbal medicines in the European Union.

The regulation and use of herbal medicines is a topic of debate due to concerns about their quality, safety, and efficacy. EU Directive 2004/24/EC on Herbal Medicinal Products was a significant step towards establishing a regulatory framework for herbal medicinal products in the EU, and bridging the gap between conventional and herbal medicines. This Directive allows herbal medicinal products to be marketed in the EU through full marketing authorisation, well-established use, and traditional use of herbal medicinal products. The framework relies on the correlation between the therapeutic claims of herbal medicine and the scientific evidence backing them up: the greater the claims made regarding medicinal benefits, the more evidence is required to substantiate its efficacy and safety. This regulatory framework acknowledges and incorporates traditional knowledge when evaluating herbal medicines, showcasing a balanced approach that values cultural traditions while mandating monographs for traditional herbal medicinal products. Excluding herbal medicines completely limits access to affordable treatment, particularly when they serve as the only alternative for some, and protects consumer autonomy. This EU framework could therefore serve as a practical guidance for the use and regulation of herbal medicines, even outside the EU. In conclusion, it is argued that the same moral imagination and courage shown by regulators in the case of herbal medicines could perhaps be used in the regulatory frameworks of other healthcare products.

Architecture and sequence stratigraphy of the Upper Coralline Limestone formation, Malta-Implications for Eastern Mediterranean restriction prior to the Messinian Salinity Crisis.

The Eastern and Western Mediterranean are separated by an elevated plateau that regulates water exchange between these two basins. The Maltese archipelago, situated atop this topographic high, offers a unique window into the evolution of this plateau in the lead up to the Messinian Salinity Crisis. The Upper Coralline Limestone Formation was deposited between the late Tortonian and the early Messinian and was probably terminated by palaeoceanographic events related to the Messinian Salinity Crisis. It represents the youngest Miocene sedimentary deposits outcropping in the Maltese archipelago. This shallow-water carbonate unit can be used to trace palaeoenvironmental changes atop the sill between the Eastern and Western Mediterranean and to explain the possible water flow restrictions to the Eastern Mediterranean that could have preceded the Messinian Salinity Crisis. Here field surveys, and analysis of the depositional environment within the Upper Coralline Limestone in Malta, are combined with recently acquired multichannel seismic reflection profiles between Malta and Gozo, to reconstruct the depositional sequence in the Malta Plateau during the late Miocene. The Upper Coralline Limestone consists of multiple coralline and larger benthic foraminifera dominated facies, extending from subtidal to intertidal environments. These accumulated in two depositional cycles observed in both outcrop and seismic reflection data. Each cycle exhibits an early aggradation-progradation phase followed by a progradation phase and a final aggradation phase. These manifest themselves in the outcrops as shallowing and deepening upwards phases. These were deposited above a deep water unit and are indicative of a preceding uplift phase followed by filling of the accommodation space through the deposition of the Upper Coralline Limestone Formation in shallow marine depths. The presence of this highly elevated sill during the late Miocene could have restricted circulation to the eastern basin.