Tagged with B

Saudi Arabia Maher Abouzeid outlines Medserve’s role as a healthcare projects incubator, focusing on identifying and filling gaps in healthcare services across the Middle East & Africa region. Their hands-on approach includes conducting market assessments, securing funding, and assembling operational teams. Abouzeid also explains the company’s latest venture, Ardens Health, the first…

USA At the American trade association’s latest CEO & Investor Conference, the board chair of the Biotechnology Innovation Organization (BIO) Ted W. Love discussed US policies and speculated about the impact of the upcoming American election on the industry while affirming that biotech continues to thrive in spite of recent challenges.…

Pharma Legal Handbook 1. Please describe the main cost containment policies in place in your country and their fundamental principles   a. Pricing and impact of generic/biosimilar approval Currently there are no policies in place in this regard.   b. Clawback/Payback/Discounts/Rebates In Portugal, the main mechanism for cost-containment is the prior evaluation, regulated…

India Clinical trials will be a pivotal part of India’s attempts to scale the global pharmaceutical value chain. Following a series of well-publicised scandals in the early 2010s, the country tightened up its clinical research regulations and saw a significant drop in trial numbers. However, with a revised regulatory landscape, a…

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Ministry of Health, Welfare and Sport (Ministerie van Volksgezondheid, Welzijn en Sport) The policy and regulation of drugs (‘medicinal products’), biologicals and medical devices falls under the jurisdiction of the Ministry of Health,…

Pharma Legal Handbook 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials do not have to be conducted locally as a condition for marketing approval. This is not one of the prerequisite conditions for approval of the clinical trial protocol, which…

Pharma Legal Handbook 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, non-prescription medications, and other medicinal products? Please refer to Chapter 1, Question 3.   2. What is the authorization process for the marketing of generic versions of these products? Please refer to Chapter 1, Question…

Pharma Legal Handbook 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? In principle, the regulatory framework set out in the previous Chapters applies. However, differing requirements or procedures apply for specific types of medicinal products. The Medicines Act distinguishes several types of medicinal products, including homeopathic…

Pharma Legal Handbook 1. What types of liability are recognized in your jurisdiction? Dutch liability law generally distinguishes between contractual liability on the one hand and non-contractual liability on the other. Non-contractual liability not only includes fault-based liability (‘onrechtmatige daad‘) but also includes a regime of strict liability for defective products (‘productaansprakelijkheid‘). The…

Pharma Legal Handbook 1. What are the basic requirements to obtain patent and trademark protection? Patents The three main criteria for obtaining patent protection are novelty, inventive step and industrial application (Article 2 Dutch Patent Act (Rijksoctrooiwet 1995), “DPA“).   Trademarks The basic requirements for obtaining trademark protection are that of a distinctive…

Pharma Legal Handbook 1. Are there proposals for reform or significant change to the healthcare system? Reform of the Drug Reimbursement System The policy on medicinal products of the Ministry of Health Welfare and Sport is based on three core values: quality, accessibility and affordability. In order to improve the affordability of healthcare,…

Pharma Legal Handbook Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? In principle, the Dutch Opium Act (Opiumwet) (“DOA“) prohibits selling or warehousing, as well as manufacturing, preparing, processing, delivering, dispensing and transporting of products included in ‘List I‘ and ‘List II‘ of the DOA. This includes cannabis: the product ‘hemp’…