News & Analysis as of

Pharmaceutical Industry › Ministry of Health

Smart & Biggar

Federal Court of Appeal dismisses appeal of SPRAVATO “innovative drug” decision

Smart & Biggar on

On November 10, 2021, the Minister of Health refused to reassess its decision that Janssen’s esketamine hydrochloride product (SPRAVATO) was not an “innovative drug” and therefore not entitled to data protection. As...more

Barnea Jaffa Lande & Co.

Monopoly fined for Unfair Excessive Price

Barnea Jaffa Lande & Co. on

The Competition Director General has issued a precedent-setting determination against the pharmaceutical marketing company MBI Pharma Ltd. (MBI). The Director General determined that MBI abused its monopolistic position and...more

Smart & Biggar

Health Canada issues Interim Order respecting drug shortages related to COVID-19

Smart & Biggar on

UPDATE: The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were published in the Canada Gazette on September 1, 2021. These amendments are intended to provide Health Canada with...more

Smart & Biggar

Federal Court of Appeal refuses to grant stay of Federal Court decision remanding Health Canada’s refusal of SHINGRIX CSP

Smart & Biggar on

The Federal Court of Appeal recently dismissed a motion brought by the Minister of Health (the Minister) for stay of a judgment of the Federal Court that held Health Canada’s refusal to issue a Certificate of Supplementary...more

Smart & Biggar

New Interim Order for COVID-19 drugs has wide-reaching impact, allowing Minister to unilaterally expand indication for...

Smart & Biggar on

UPDATE: See our article here regarding transitional measures. On September 16, 2020, Canada’s Minister of Health approved an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to...more

Hogan Lovells

Impact of Spanish government's COVID-19 measures on life sciences companies operating in Spain

Hogan Lovells on

With more than 17,000 people currently infected in Spain, the national government has granted the Ministry of Health far-reaching powers to contain the coronavirus, and has issued several orders to safeguard the economy....more

Goodwin

Roche Fined $14M for Undermining Biosimilar and Generic Competition in Romania

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On January 15, 2020, the Romanian Competition Council fined fined Roche Romania SRL €12.9 million ($14.2 million) following two investigations into what the Competition Counsel found to be Roche’s anti-competitive practices...more

K&L Gates LLP

Japan’s Ministry of Health Revisits Generics

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The Ministry of Health, Labor and Welfare (MHLW) has announced a new policy regarding generic pharmaceuticals in an attempt to stem the rise of health care costs. Japan spends JPY50 trillion (of which approximately one fifth...more

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