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European Commission Adopts South Korea Adequacy Decision

  • 23/12/2021
  • Articles

On 17 December 2021, the European Commission announced its decision on the adequate protection of personal data by the Republic of Korea (South Korea). After the conclusion of adequacy talks in March 2021, the adoption of the decision marks the final step in the adequacy process.

With the adequacy decision, personal data can be transferred freely from the EU to South Korea.

Please click on the link below to read our note on the subject.

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    • 27/06/2022
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    Spanish Competition Authority Set to Continue Excessive Pricing Probe Against Leadiant

    On 15 June 2022, the Spanish competition authority (Comisión Nacional de los Mercados y la Competencia – CNMC) rejected the appeal by Leadiant Biosciences SpA, Leadiant Biosciences Ltd, Leadiant GmbH and Sigma Tau Arzneimittel GmbH (together, Leadiant) against the decision of the Competition Directorate of the CNMC of 3 March 2022 to discontinue the settlement negotiations with Leadiant aiming to terminate the abuse of dominance probe which the CNMC launched against Leadiant on 22 December 2020 for alleged excessive pricing of chenodeoxycholic acid (CDCA) (see, Van Bael & Bellis Life Sciences Insights and News Alert of 22 December 2020). CDCA is an orphan medicine indicated for the treatment of patients afflicted with cerebrotendinous xanthomatosis, a rare metabolic disorder. In support of its appeal, Leadiant submitted that the Competition Directorate had violated Article 47 of the Spanish competition law (Law 15/2007, 3 July 2007) by rejecting its proposed commitments and ending the settlement procedure. More precisely, Leadiant argued that the Competition Directorate had infringed its rights of defence and had caused it irreparable harm, which are two possible grounds of appeal under Article 47 of the Spanish competition law. First, regarding the alleged infringement of Leadiant’s rights of defence, the CNMC held that the Competition Directorate had, in fact, provided Leadiant with a sufficiently detailed and reasoned explanation as to why it rejected the proposed commitments. Hence, Leadiant’s rights of defence had not been violated. Second, regarding its alleged irreparable harm, Leadiant argued that this harm would result from a violation of Article 47(1)(b) and (e) of Law 30/2015, 1 October 2015, which regulates the common administrative procedures in the Spanish public sector. Pursuant to these provisions, a decision is void if it was adopted by an authority which is not competent or if the procedure followed is not the adequate one for that decision. However, the CNMC disagreed with Leadiant, holding that the Competition Directorate was competent and had complied with all applicable legal requirements. Consequently, the CNMC concluded that the Competition Directorate’s decision was not void, had not ignored Leadiant’s right of defence and had not caused irreparable harm. This implies that the CNMC will continue its excessive pricing probe against Leadiant. A final decision is expected before August 2023. Leadiant’s pricing practices have already been fined in the Netherlands (see, Van Bael & Bellis Life Sciences Insights and News Alert of 20 July 2021) and Italy (see, Van Bael & Bellis Life Sciences Insights and News Alert of 1 June 2022), whilst they are being investigated in other Member States including Belgium (see, Van Bael & Bellis Life Sciences Insights and News Alert of 9 September 2019).

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    • 23/06/2022
    • Articles

    Belgian Government Think-Tank Publishes Study on Compulsory Licensing for Expensive Medicines

    On 14 June 2022, the Belgian Health Care Knowledge Centre (KCE), a research institute funded by the federal government, published a study discussing “Compulsory Licensing for Expensive Medicines” (the CL Study). The CL Study was commissioned by the Committee for Health and Equal Opportunities of the federal Chamber of Representatives which is reviewing bill 55K407 that seeks to expand the existing system of compulsory licensing for patented medicinal products in the interest of public health (Article XI.38(1) Code of Economic Law). The publication of the CL Study preceded by a few days the adoption of an intellectual property waiver for Covid-19 vaccines by the Twelfth Ministerial Conference of the World Trade Organisation (see, Van Bael & Bellis Life Sciences News and Insights of 20 June 2022) and was almost immediately welcomed in Parliament by the Minister of Social Affairs and Public Health. While the compulsory licensing of pharmaceutical patents is therefore clearly a trending topic, the CL Study is strikingly cautious in making policy recommendations. This is because compulsory licensing for expensive medicines not only raises questions of principle but also of practical implementation. Additionally, high medicine prices are generally the result of increasingly complex technological innovations. The CL Study therefore advocates a comprehensive approach that considers the entire regulatory framework, not just patent law, and is in favour of calibrated measures that do not jeopardise the benefits of the current system which seeks to encourage and reward innovation. That is a crucial concern for a country such as Belgium which hosts a thriving ecosystem of pharmaceutical and biotechnological research, development, clinical trials and production facilities. Additionally, the incentives for innovation encompass a range of measures covering patent law, know-how, data and market exclusivity, and targeted rules that stimulate the development of orphan and paediatric medicines. Lastly, the CL Study fully recognises the difficulties associated with defining an excessive price for medicines. It notes that the excessive pricing cases brought by European competition authorities all involve off-patent medicines (for a recent example with regard to Leadiant, see, Van Bael & Bellis Life Sciences News and Insights of 1 June 2022). On this basis, the CL study makes the following policy recommendations: • Compulsory licensing should not be an end, but rather a means to bring down prices in exceptional circumstances. • EU Member States should coordinate any initiatives to impose compulsory licensing in specific cases. • Adaptations to the current rules governing exclusivity and data access could be envisaged but require careful consideration. • In Belgium, the exchange of expertise between pricing and reimbursement authorities and the Belgian Competition Authority should be improved. • There is always scope for a more robust pricing and reimbursement policy and increased cooperation at EU and international level. • The patent exemption for pharmacists should be optimised. • Universities and public research institutions should apply “socially responsible licensing conditions”. • Collaborative models for patent licensing should be encouraged.

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    • 20/06/2022
    • News

    European Commission Starts Competition Investigation against Vifor Pharma regarding Disparaging Statements Made against Rival's Medicine

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