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Entry into Force of First Agreement for Supply of COVID-19 Vaccine between European Commission and AstraZeneca

  • 31/08/2020
  • Articles

On 27 August 2020, the European Commission (the Commission)  published a press release annoucing the entry into force of an agreement with AstraZeneca for the supply of a vaccine against COVID-19, as and when it becomes available (see, attachment). The agreement is the first of its kind which the Commission negotiated on behalf of the EU Member States. It provides for the purchase of 300 million doses with an option for a further 100 million doses and will benefit all of the Member States, in addition to a range of lower and middle income countries or other European countries.

The vaccine still has to complete the EU marketing authorisation procedure administered by the European Medicines Agency. It is currently subject to a large-scale Phase II/III clinical trials. AstraZeneca is said to be taking high risks and will be indemnified for specific liabilities by the Member States, while remaining liable for a number of other, unspecified events.
The Commission continues talks with other vaccine producers, including CureVac, Johnson & Johnson, Moderna and Sanofi-GSK, in hopes of concluding similar agreements with those firms. These discussions and resulting agreements form an important part of the Commission’s European Vaccines Strategy which it adopted in June 2020 see, Van Bael & Bellis Life Sciences News Alert of 18 June 2020).


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    • 24/09/2020
    • Articles

    Dutch Competition Authority Closes Probe of AbbVie's Discount Policy for Humira® and Accepts Commitments

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    • 21/09/2020
    • Articles

    Entry into Force of Second Agreement for Supply of COVID-19 Vaccine between European Commission and Sanofi-GSK

    As part of its European Vaccines Strategy adopted in June 2020 (see, Van Bael & Bellis Life Sciences News Alert of 18 June 2020), the European Commission (the Commission) announced on 18 September 2020 the entry into force of a second agreement providing for access to a potential vaccine against Covid-19 (see, attached press release). The Commission’s partner for the new agreement is Sanofi-GSK which has promised to sell up to 300 million doses of the new vaccine if the product materialises. The agreement would seem to emulate a similar deal with AstraZeneca in that the Commission secures the supply of vaccines for EU Member States and for a range of lower and middle income countries while financing part of the vaccine’s upfront development costs (see, Van Bael & Bellis Life Sciences News Alert of 31 August 2020). The vaccine now forms the subject of clinical trials and may become available in the second half of 2021 if it completes successfully its regulatory trajectory. Sanofi and GlaxoSmithKline are developing a recombinant vaccine against Covid-19 that builds on Sanofi’s S-protein Covid-19 antigen, based on recombinant DNA technology, and GSK’s adjuvant technology. The combined approach is hoped to enhance the immune response and facilitate the production of vaccines on a large scale.

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    • 15/09/2020
    • Articles

    US President Signs Another Executive Order Implementing International Pricing Index Model

    On 13 September 2020, the US President signed another executive order (the New Order) implementing an international pricing index model (see, attachment). At the same time, he revoked an earlier such order signed at the end of July 2020 (see, Van Bael & Bellis Life Sciences News Alert of 28 July 2020). The New Order is more a political manifesto than a set of technical rules. It once more bemoans the allegedly unfair price differences for many prescription medicines between the US and other developed nations and posits that US citizens are thus “subsidizing innovation and lower-cost drugs for the rest of the world”. Additionally, the New Order expresses concern about access to medicines in that “high drug prices in the United States also have serious economic and health consequences for patients in need of treatment”. The New Order seeks to remedy these problems in similar fashion to what the July order tried to achieve and dictates that the price of qualifying medicines should not exceed that of the most-favoured nation price (MFNP) for these medicines. The MFNP is defined as the “lowest price, after adjusting for volume and differences in national gross domestic product, for a pharmaceutical product that the drug manufacturer sells in a member country of the Organisation for Economic Co-operation and Development (OECD) that has a comparable per-capita gross domestic product.” On that basis, the Secretary of Health and Human Services is directed to develop and test a payment model which implements the MFNP for two categories of medicines. Critics were quick to point out that the elaboration of a payment model does nothing more than signaling the start of a potentially lengthy administrative process. Still, developed nations are again at the receiving end of a strong message that prices for medicines in overseas markets that were developed in the US are likely to go up rather than down, regardless of their actual development costs.

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