Tagged with Regulation

India Anay Shukla leads the pharmaceutical, life sciences, med-tech and healthcare practice at Nishith Desai Associates, a leading Indian law firm. In this article, he examines the benefit of the recent policy changes to price controls for innovative drugs in India.  Unlike many other countries, India controls prices of all drugs…

Malaysia After 61 years of single-party rule, the May 2018 electoral victory of the populist Pakatan Harapan (PH) coalition sent shockwaves through the Malaysian political landscape. This has been keenly felt within the healthcare sphere, where industry players are broadly supportive of PH’s plans to increase low-income Malaysians’ access to treatments…

India Dilip Shah, the Secretary-General of the Indian Pharmaceutical Alliance advocates for a stronger and more empowered regulator in India if the country is to build public confidence in its pharma output and drug inspectors.    Improving the image of drug inspectors- will require investments in “infrastructure”. The key elements of this…

China In late 2018 China adopted a novel procurement scheme with the aim of dramatically cutting the amount being paid for generic drugs. The policy’s effect on pricing stands to hit domestic generic firms hardest unless they adapt their business models. Big Pharma could also lose out as their off-patent originators…

Egypt Egypt continues to struggle with fake drugs reaching the hands of patients as the suppliers of counterfeit medicines become more sophisticated by adding company logos to packaging.   The Egyptian police have launched large-scale surveillance campaigns aimed at “Bir Al-Salam factories” which are known for manufacturing these drugs that include multiple unknown…

Egypt The Health Committee of the Egyptian House of Representatives is preparing to discuss a draft law from the government on the establishment of the “Egyptian Drug Authority.”   The new entity will specialise in all medicine-related issues, from pricing to shortages to registering new drugs.   Similarly to Europe’s European Medicine…

Korea The administration of President Moon Jae-in is moving to ensure the enduring success of South Korea’s healthcare and life sciences industries through increased international collaboration. However, some pharma insiders are calling for even greater governmental support for what is still a tightly regulated sector facing pressures over pricing, exacerbated partly…

Opinion Chester “Chip” Davis, Jr, the President and CEO of the Association for Accessible Medicines (AAM) in the US urges Congress to avoid restricting out-of-court drug patent settlements and to move away from anti-competitive practices that work to restrict patients access to generics and biosimilars.    Recent legislation introduced in the US Senate would…

Opinion Our contributor at large, David Crean, Managing Director for Objective Capital Partners, attended J.P. Morgan’s 2019 Health Care Investor Conference, one of the biggest events in the life sciences calendar and a fantastic indicator of what is to come in healthcare for the year ahead. Here, Crean gives us the inside scoop. …

IFPMA Eli Lilly and Company’s Melissa Barnes, who chairs the Ethics and Business Integrity Committee (eBIC) at the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), and Thomas Cueni, the organisation’s director general, outline the key features of the IFPMA’s ambitious new Code of Practice and discuss the state of ethics…

Generics Over the last ten years, generic medicines have increased access to medicines by over 100% in 7 key therapeutic areas and have provided massive savings for healthcare systems in Europe. In this exclusive interview with Adrian van den Hoven, director general of Medicines for Europe, we discuss the importance of…

IFPMA Last week, the IFPMA released their new Code of Practice with the aim of encouraging complete integrity and ethical responsibility within the pharmaceutical industry. We do not want anything to even potentially suggest that we are trying to get between the healthcare professional and the patient at the time of…