From 25 to 29 January 2022, the 150th session of the World Health Organization’s (“WHO”) Executive Board (“EB”) took place in Geneva, Switzerland. Two years into the COVID-19 pandemic, a central theme for this session was the management of global health emergencies. This post briefly outlines the main take-aways for pharmaceutical companies.
First, the
From 25 to 29 January 2022, the 150th session of the World Health Organization’s (“WHO”) Executive Board (“EB”) took place in Geneva, Switzerland. Two years into the COVID-19 pandemic, a central theme for this session was the management of global health emergencies. This post briefly outlines the main take-aways for pharmaceutical companies.
First, the
On March 4, 2021, Brazil deposited with the United Nations its ratification of the Nagoya Protocol (“Protocol”) (see here the announcement of Brazil’s Ministry of Foreign Affairs). This represents Brazil’s formal commitment to be bound by the Protocol.
On August 6, 2020, the Brazilian Senate passed a Decree that ratifies the Nagoya Protocol. The Protocol complements Brazil’s existing access and benefit sharing rules relating to Brazil’s genetic heritage and associated traditional knowledge (“ABS Framework”). One important effect of this ratification is that other countries parties to the Protocol will have to ensure that users of Brazilian genetic heritage and associated traditional knowledge comply with the Brazilian ABS Framework. However, the inverse is also true. Brazil will need to ensure that Brazilian users of foreign genetic heritage and associated traditional knowledge comply with the access and benefit sharing regime of the country of origin.
On January 21, 2021, the European Commission opened two public consultations on the review of the EU Blood Directive and the EU Tissues and Cells Directive. Both Directives are more than fifteen years old, and their implementation diverges widely across the member states. The rules on human blood and tissue gain increasing importance for
Over the past months, the Government has regularly posted technical guidance notices on what it calls a “no deal” Brexit, i.e., a scenario in which the UK and the EU will not reach an agreement and the UK will become a third country on 29 March 2019. The UK Government has now published four notices addressed specifically to UK food and beverage producers outlining its plans for a no-deal Brexit. The notices emphasise that the Government believes a no-deal scenario is unlikely, and essentially summarise the Government’s policy decision on certain key issues. Key areas covered by the notices include geographical indications, food labelling and exports of food containing ingredients of animal origin. These are discussed further below.
Geographical indications (“GIs”)
The Government indicates that it is keen to protect UK products that benefit from a GI, and if no agreement is reached then it intends to set up its own GI scheme. The Government argues that it will “broadly mirror the EU regime and be no more burdensome to producers”. Businesses will have to wait until early 2019 for detailed guidance on what it will involve, but the notice confirms the following:
Producers will need to adjust product packaging/labelling to include the new UK GI logo.
It is unclear whether, following a no-deal Brexit, current UK GIs would still be protected under the EU regime. The UK Government assumes that existing UK GIs “will continue to be protected by the EU’s GI schemes”, but this is not guaranteed. If current UK GIs are not protected under the EU regime after 29 March 2019, then UK producers wishing to regain EU GI status will need to submit applications to the European Commission as third country producers. The notice also highlights that companies should consider applying for EU Collective Marks or EU Certification Marks through the EU Intellectual Property Office (“EUIPO”) or the World International Property Organisation (“WIPO”).
The Government has recently launched a consultation for its proposed GI scheme. Responses may be submitted until 1 November 2018 on the DEFRA website.
Food labelling
The Government’s no-deal Brexit notice on food labelling raises two main issues.
First, labels on products manufactured in the UK would no longer fall within the scope of “EU” as a descriptor of origin. This applies to both products sold in the UK and the EU.
Continue Reading UK Government Issues “No Deal” Brexit Notices for the Food & Beverage Sector
On January 19, 2017, Advocate General (“AG”) Szpunar delivered his Opinion in case C-591/15, The Gibraltar Betting and Gaming Association Ltd. In this case, the Court of Justice of the EU (“CJEU”) must decide whether Gibraltar and the UK are to be treated as if they were part of a single Member State for the
In October 2014, the Nagoya Protocol entered into force. It created a new international regulatory system affecting all life science companies that conduct R&D on biological material such as animals, seeds, flowers, viruses, fragrances, flavonoids, essential oils, enzymes, yeasts, and so on. So far, compliance by companies is progressing slowly due to unawareness of the