A Rose By Any Other Name … May Carry A Higher Duty Rate
As countries work to harmonize international trading rules and develop bilateral and regional Free Trade Agreements (FTA), there remain certain international trade truths that all international traders should understand. Central to those is the principle of tariff classification. No matter the country, all imported products must be classified under the Harmonized Tariff System and will be assessed duty at the corresponding duty rate applied by the importing country. This globally managed system of tariff classification is guided by the World Customs Organization (WCO) and applies to all WCO member states.
International trade truth number two is that all merchandise must be classified, and therefore assessed duty, based on its condition at the time of entry. Tariff classification may be based on a variety of factors, including what a product is, its material composition, how it works, where it is used, and to whom … Read More »
New FDA Informed Consent Requirements for Applicable Clinical Trials: Practical Approaches for Implementation
For applicable clinical trials regulated by the U.S. Food and Drug Administration (FDA) that are initiated on or after March 7, 2012, sponsors, investigators and institutional review boards will have to assure compliance with an additional informed consent requirement.1 A revision of FDA regulations requires investigators and sponsors of such clinical trials to include the following statement in informed consents:
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Website will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
ClinicalTrials.gov is the National Institutes of Health (NIH) website where all “applicable clinical trials” must be registered and trial results posted in accordance with the U.S. Food Drug Administration Amendment Act of 2007 (FDAAA).2 Registration … Read More »
CMS’s Proposed “Sunshine” Regulations: Implications for Research
On Dec. 19, 2011, the Centers for Medicare & Medicaid Services (CMS) released a Proposed Rule to implement § 6002 of the Patient Protection and Affordable Care Act (PPACA), commonly referred to as the Physician Payment Sunshine Act (Sunshine Act). The Sunshine Act was included in PPACA to enhance disclosure and transparency of financial arrangements among physicians, teaching hospitals, and manufacturers of federally reimbursable drugs and biologicals and covered medical devices and medical supplies, and thereby reduce the risk of inappropriate financial incentives interfering with medical judgment and patient care. The Proposed Rule details requirements for processing and reporting payments by pharmaceutical, device, biological and medical supply “applicable manufacturers”1 to physicians and teaching hospitals that are “covered recipients.”2 The Proposed Rule also sets forth requirements for reporting ownership and investment interests held by physicians and their immediate family members in … Read More »
Life Sciences – Just Another Way to Say “Intellectual Property”?
There is no corner of the American economy more deeply dependent on intellectual property rights than the life sciences. Of course, we all know that patents have long been central to the success of pharmaceutical and medical device manufacturers, and the unanimous decision in the Prometheus case this past month has brought additional scrutiny to a market segment often misunderstood in the popular press. That said, for players in the life sciences space, patents are only one of many ways that intellectual property shapes their business. In fact, the trademark, unfair competition and copyright laws can be just as critical, and a strategic understanding of their value can provide companies with real ownable distinction in the market.
What is a product with “ownable distinction?” It is the opposite of a generic commodity, and it is the holy grail in the life … Read More »
The FTC Finally Issues its Report on Consumer Privacy
Interactive marketing is everywhere, and the Federal Trade Commission has struggled mightily over the past several years to deal with complex privacy issues that grow out of sophisticated, data-intensive marketing practices. On March 26, the FTC released its long-promised final report on consumer privacy. Critically, we now have a sense of the FTC staff position on future legislation, best practices and the secondary market in customer data.
The FTC was clear that it wants additional legislation to address general privacy concerns, data security and breach notifications. This is a change from the staff’s prior position that self-regulation would be sufficient, and lends weight to current efforts before congress to do exactly that (although the fact that we are currently in a highly partisan election year does diminish the likelihood of immediate action).
The rest of the report flowed logically from the principles … Read More »