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Focus on Regulation

Pharma Companies May Benefit from Proposed Patent Law Changes in China; Public Comment Invited

On January 4, China’s National People’s Congress (NPC) released draft amendments to the Chinese Patent Law, proposing expanded and enhanced protections that may provide real benefits to companies that develop new drugs.  A potentially important condition to one of the key proposed changes specific to new drugs is that it would be available only for products that are submitted for marketing approval concurrently in China and other countries.  Although clearly intended to motivate companies to prioritize seeking new drug approvals in China, the proposed patent term extension would appear to be limited to products that are first submitted for marketing approval to China and another country, and would not apply to products first filed only in China.  As a practical matter, this may limit the usefulness of the provision.

The most significant change that’s targeted to drug products would be the possibility of Continue Reading

China antitrust authority consults on agreements rules

On 3 January 2019, the State Administration for Market Regulation (SAMR) released a draft of the Regulation on the Prohibition of Monopoly Agreement Conduct (Draft) on its website, inviting comments from interested stakeholders. The consultation period ends on 3 February.

The Draft is the first significant normative output in the Anti-Monopoly Law (AML) field after the establishment of SAMR and the transfer of antitrust powers from the three prior antitrust units at the National Development and Reform Commission (NDRC), the State Administration for Industry and Commerce (SAIC), and the Ministry of Commerce to SAMR in Spring 2018.


The Draft is divided into 5 chapters, and has 44 provisions. Unlike the prior regulations adopted by SAMR’s predecessor bodies NDRC and SAIC, the Draft Continue Reading

European Commission publishes factsheet on medical devices and in vitro medical devices for non-EU and non-EEA competent authorities


The European Commission has published a factsheet addressed to competent authorities of third countries. This factsheet is one of several guidance documents published by the European Commission to clarify points and answer questions regarding the implications of the Medical Device Regulation (MDR) and the In Vitro Medical Device Regulation (IVDR).

The factsheet is intended to facilitate the import into the EU and export of medical devices from the EU during the transition period.

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Updated UK “no deal” Brexit guidance on medicines, medical devices and clinical trials

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance on how the UK would regulate medicines, medical devices and clinical trials in the event that the UK leaves the EU on 29 March 2019 with no withdrawal arrangements in place, referred to as a “no deal” scenario.

The guidance updates the MHRA’s technical notice published in August 2018 (see our previous blog on the technical notice) and takes into account the responses to the public consultation in October 2018 on the changes that would be necessary to current UK legislation in the event of a no deal Brexit (see our previous blog on the consultation).

The updated guidance is broadly consistent with the previous position but provides additional details and confirmation on aspects such as the process and timing of marketing authorisation assessments, to help businesses prepare for a possible “no deal”. As well as setting out the key regulatory arrangements that the UK would put in place in the event of a “no deal”, it is noticeable that the updated guidance no longer describes a “no deal” scenario as “unlikely” and instead states that “It has always been the case that as we get nearer to that date, preparations for a no deal scenario would have to be accelerated. We must ensure plans are in place should they need to be relied upon.”

The guidance confirms that in the event of “no deal”, the UK would no longer participate in the EU regulatory networks for medicines or medical devices and the functions currently carried out at EU level for such products on the UK market would be transferred to the MHRA.

The key points in the updated guidance for pharmaceutical and medical device companies are summarised below. Continue Reading

The European Commission started implementing its “no-deal Brexit” Contingency Action Plan


On 19 December 2018, the European Commission published a Communication addressed at the EU institutions. The Communication relates to the preparation for the withdrawal of the United Kingdom from the European Union, in case of a “no-deal” Brexit. The Communication discussed 14 measures that the European Commission has adopted to prepare for the “no-deal” Brexit scenario.

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Likely FDA Impact of the Government Shutdown: Regulatory Submission Reviews, Inspections, and Research Projects

The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for FY 2019.  Unfortunately, FDA is one of the agencies with at least some functions shut down, as was announced yesterday.  Among other things, FDA has furloughed 42% of its employees, according to a tweet from Commissioner Scott Gottlieb, M.D.  Nonetheless, Dr. Gottlieb said the agency would be “continuing vital activities, to the extent permitted by the law, that are critical to ensuring public health and safety in the United States,” including: Continue Reading

Small Business Runway Extension Act of 2018 Becomes Law: Increases Revenue Look-back Period to Five Years for Small Business Size Eligibility Determinations

On December 17, 2018, the Small Business Runway Extension Act of 2018 (“Act”) (H.R. 6330) was passed by President Trump into law. The new law amends the Small Business Act at 15 USC 632 to require that the size of a federal contractor for purposes of determining small business eligibility be measured based on the average of five years rather than three years of annual revenue. Ultimately, this increase in the Small Business Administration (“SBA”)’s look-back revenue period will allow more small businesses to qualify as “small” for federal contracting purposes for a longer period of time.

How does a federal contractor’s revenue impact its small business eligibility?

Under the Small Business Act, in order to qualify as a small business, Continue Reading

Appetite for anti-unfair competition action in the Internet space

It’s been almost a year since the new “Internet clause” in China’s Anti-Unfair Competition Law (AUCL) is in force. The enforcement authority hasn’t used it much in 2018. But one decision is noteworthy.

AUCL amendment

On 1 January 2018, the first amendment to the AUCL since its enactment in 1993 came into effect. One of the major changes it brought was the addition of a new “Internet clause.” Article 12 of the amended AUCL prohibits the use of technological means to obstruct or disrupt the regular operations of online competitors, and lists several examples of unfair competition practices. Continue Reading

Effects of Brexit on reimbursement decisions concerning medicinal products in Poland

The President of the Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products (URPL) estimates that approximately 20% of all the 10,000 medicinal products registered in Poland will be affected by the effects of Brexit. Out of this number, according to media reports, new reimbursement decisions will need to be issued for up to 500 products.

In view of a potential “no-deal” Brexit, and the transfers of UK based entities to other EU member states, the Minister of Health has recently issued a statement [1] in which he presented the Ministry’s position concerning the effects of Brexit on the reimbursement decision that had previously been issued in Poland.

The Minister informed that in the event of a change of a marketing authorization holder, which at the same time was the applicant for the reimbursement decision, the recommended procedure would be to simultaneously submit: Continue Reading

EMA publishes draft Guideline on clinical investigation of haemophilia B medicinal products


The EMA has published a draft Guideline on clinical investigation of recombinant and human plasma-derived factor IX products.[1] The purpose of this guideline is to provide applicants and regulators with harmonised requirements for applications for marketing authorisation of haemophilia B medicinal products. In July, a similar guideline was adopted concerning haemophilia A medicinal products.

The draft describes data that needs to be collected during clinical trials for a haemophilia B medicinal product prior to application for an application for Marketing Authorisation (MA).

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