Month:

September 2017

The Hague Convention on the Protection of Children and Co-operation in Respect of Intercountry Adoption

Hague Conference on the Protection of Children and Co-Operation in Respect of Intercountry Adoption Convention is an international treaty agreement protecting the best interests of children in international adoptions. The Hague Convention (“Convention”) establishes standards of practice that are adhered to by the member countries. The overall goal is to protect children in the international adoption process while preventing the abduction, exploitation, sale and trafficking of children. The convention applies to any US citizen who is a US resident in the adoption of any child from certain countries.

Harvey Heralds Change: The Combusting Compliance of Emergency Response to Hazardous Materials

In the wake of Hurricane Harvey’s severe flooding, the Arkema chemical plant in Crosby, Texas has made quite the media splash. Rising waters left the plant without power, forcing workers to transfer volatile organic peroxides into large refrigerated trucks with independent generators. In up to six feet of water, several of the trucks’ refrigeration systems failed, resulting in combustion of the hydrogen peroxide, a hazardous material under the Occupational Safety and Health Administration (OSHA) standards. This is not the first example of chemical plants having issues with natural disasters; there were significant hazardous material concerns after Hurricane Katrina in 2005 and more recently the Fukushima nuclear plant in 2011. With no indication that these problems will be resolved, it is important to once again look at regulations placed on chemical plants in response to emergency.

A Look at Regulation Systems Compliance and Integrity

The U.S. Securities and Exchange Commission (the “SEC”) adopted Regulation Systems Compliance and Integrity (“Reg SCI”) to strengthen the technology infrastructure of the U.S. securities markets by imposing new regulatory requirements on SCI entities. The term “SCI entity” includes self-regulatory organizations (“SROs”) such as stock and options exchanges, registered clearing agencies, the Financial Industry Regulatory Authority (“FINRA”), and the Municipal Securities Rulemaking Board (“MSRB”); certain alternative trading systems; disseminators of consolidated market data, such as the Consolidated Tape Association; and certain exempt clearing agencies. The regulatory requirements were designed to reduce the occurrence of systems issues, improve resiliency when systems problems do occur, and to enhance the SEC’s oversight and enforcement of securities market technology infrastructure.

Is Nuclear Energy Here to Stay?

Nuclear power last made front-page news approximately six years ago. Unfortunately for nuclear power, headlines on the subject more often than not represent times of trouble. In regaining the spotlight in the wake of the recent announcement to discontinue construction of the new AP 1000 reactors, clean energy advocates and companies with predominantly clean energy portfolios are making headlines again. The issue, this time, is money.

Dealing with 71 Medical Licensure Boards: American Doctors Trip Over State Lines

In April 2013, members of the Federation of State Medical Boards (FSMB) and the Council of State Governments (CSG) embarked on a venture to create the Interstate Medical Licensure Compact (the Compact or IMLC), a voluntary, expedited pathway to licensure for qualified physicians who wish to practice medicine in multiple states. On April 20, 2017, the Interstate Medical Licensure Compact Commission, (IMLCC) issued its first Interstate Medical License to a Wisconsin physician who applied to practice in Colorado, setting a groundbreaking precedent in medical licensure portability. While the IMLC is a great first step toward increasing access to healthcare by expanding licensure portability, this initiative faces multiple regulatory hurdles.

Government Scrutiny of Patient Assistance Programs

In the eyes of underinsured or uninsured patients, Patient Assistance Programs (PAPs) offer access to otherwise unaffordable medications. However, there are questions being raised whether PAPs are being abused by manufacturers as an inappropriate inducement. The government is increasing its inquiries into PAPs and is beginning to take more investigative action.  PAPs are often funded by charitable donations from companies who benefit from the PAP paying for co-insurance for the very drugs the company manufactures. It is essential for companies seeking to develop or maintain charitable donations to remain compliant with existing regulations, but also be aware of forthcoming regulations as a result of present actions.

Compliance Spotlight: Dominique Vittori, Abbott Laboratories

Dominique Vittori is a Regulatory Affairs Associate for Abbott Laboratories working within Abbott Diagnostics Division. Abbott Laboratories is a worldwide healthcare company that is most known for pharmaceutical development but eventually branched out to include medical devices, nutritional products and research-based drugs/pharmaceuticals. Ms. Vittori earned her Bachelor’s degree from the University of Illinois, where she majored Molecular and Cellular Biology. Ms. Vittori sought a career in compliance because of the opportunity to put her background and expertise in the sciences to use in a corporate setting, and has been most rewarded by the ability to see the tangible results of her work at Abbott Labs.

The following is an interview with Ms. Vittori where she gives an inside look into her daily life as a compliance professional.

History of Emergency Prescription Fulfillment Policies in the Wake of Hurricanes Harvey and Irma

In the midst of a natural disaster people gather their children and pets, try to locate a temporary home, and worry what situation they may come home to. The first things people think to grab have nothing to do with their prescription drugs. However, according to a study performed by the U.S. Department of Health and Human Services, from 2011-2014, 46.9% of the population was prescribed a drug in the last 30 days; prescription drugs are an important factor in many peoples’ lives. When portions of the population are displaced from their homes during a natural disaster, they often forget their pill bottles and/or prescriptions. Thankfully, following Hurricane Katrina, regulations were put in place to help people in these situations.

Hurricanes Harvey and Irma Add Urgency to Congressional Flood Insurance Reform Effort

In 2016, Congress introduced a bill to reform the National Flood Insurance Program.  Proponents of the bill saw it as necessary reform to a debt-ridden and ineffective program, while opponents saw it as an attack against a necessary safeguard for coastal Americans. The National Flood Insurance Program was set to expire at the end of September 2016, until Congress extended the program through December 8, 2017.  As Americans rebuild from Hurricanes Harvey and Irma, Congress contemplates reform and seeks to keep the program funded past December.