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If Vice President Biden’s election is confirmed, we anticipate a somewhat more assertive regulatory posture in certain areas to develop over time.

As some of you may recall, the Obama Administration was very active on nutrition issues. Participants will recall that First Lady Michelle Obama was very engaged on those issues.

One item that remains

On 10 September 2020, the German Federal Social Court (Bundessozialgericht – “BSG”) has issued an important decision with significant impact on the drug pricing and reimbursement system. It ruled that a pharmaceutical company can file a direct legal action against the early benefit assessment in the so-called AMNOG process. This was not possible so far.

Drug manufacturers have responded to the COVID-19 pandemic by adopting measures to ensure continuity in their operations—continuity that is vital to safeguarding the global drug supply. In doing so, some have faced unprecedented challenges with regard to ensuring the health of their employees, preventing COVID-19 transmission at their facilities, and mitigating associated risks to product

The Trump Administration has released the much-anticipated executive order entitled “Lowering Drug Prices by Putting America First” (commonly referred to as the “Most-Favored-Nation” or “MFN” executive order). President Trump initially had announced the MFN executive order during his July 24, 2020 press conference highlighting four separate executive orders aimed at drug pricing. However,

The European Commission has just adopted a Regulation that will lift the existing ban on imports of poultry meat from Ukraine that was triggered by the January 2020 Highly Pathogenic Avian Influenza (“HPAI”) outbreak in the western part of the country.

On January 19, 2020 the Ukrainian authorities informed the World Organization of Animal Health

Consistent with popular predictions and our prior posts, Congress made drug pricing a key item on its investigative agenda in the first year of the 116th Congress.  Several factors contributed to the uptick in congressional drug pricing oversight activity, including the elevation of new Democratic chairs in the House with longstanding interests in drug

  • Drug pricing presents intriguing political dynamics. Whether and what policy prescriptions actually come to fruition in the next two years remain to be seen, but the rhetoric around the imperative to lower drug pricing — and the political pressure to act — will be more intense than we have seen to date.
  • President Trump and

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:

  • The scheme will be compliant with the World Trade Organisation (“WTO”) Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”).
  • All 86 UK GIs currently protected under the EU scheme will automatically be given new UK GI status.
  • The UK would not have to recognise EU GI status anymore.

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

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

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