International Trade Health

Read need-to-know updates, commentary, and analysis on International Trade issues written by leading professionals.
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Health Alert (Australia) - November 23, 2015

In This Issue: -Judgments; Legislation; and Reports -Excerpt from Judgments: Commonwealth. Federal Court - 17 November 2015 - Burnett v Eastern Health [2015] FCA 1247 The Federal Court of Australia...more

Your daily dose of financial news The Brief – 11.23.15

Clocking in at an as-promised $150 billion, the Pfizer/Allergan merger is a done deal, marking one of the biggest ever takeovers in the health care industry. As mentioned here last week, the deal finalization comes on the...more

The 37th International Conference of Data Protection & Privacy Commissioners – Some Observations

The annual conference of the world’s data protection regulators is a three day exercise, with half of the conference being “closed door” for the regulators only, and the other half being a series of side meetings and...more

Washington, D.C. Update – November 2015

In the final week of October, congressional leaders and the White House reached an agreement on a wide variety of measures to "clean the barn" for Speaker John Boehner's (R-OH) successor. The Bipartisan Budget Act of 2015...more

Africa Update - November 2015 #2

Leading the News: Egypt - On November 5th, U.S. President Barack Obama expressed his belief it was possible there was a bomb on board the Russian passenger jet that went down in Egypt’s Sinai Peninsula last week....more

FCPA Compliance and Ethics Report-Episode 210-Don Sinko, Chief Integrity Officer at the Cleveland Clinic [Video]

In this episode I visit with Don Sinko, the Chief Integrity Officer of the Cleveland Clinic, a world wide health care and health services provider. He talks about some of the challenges of ethics and compliance in such an...more

Life lines: Life sciences M&A and the rise of personalised medicine

The second report in our Deal Dimensions series, written in collaboration with Mergermarket and launched today, reveals that 94 per cent of life sciences companies are planning an acquisition in the next year, with more than...more

Health Care E-Note - October 2015

For health care professionals who began accepting Meaningful Use incentive money at the outset of availability under the Medicare option in 2011, the year 2015 is an important year. By starting early, eligible health care...more

The Oman Update - Official Gazette 1119

Sultani Decrees Sultani Decree No. 37/2015 Transferring Officials to the Ministry of Foreign Affairs. Nasser bin Mohammed bin Khalifa Al Busaidi and Mohammed bin Ahmed bin Saleh Al Balushi are to be transferred from...more

Data-Harvesting Zombie Hackers, Blood-Thirsty Auditors, and Other Reasons to be Scared on Halloween

This Halloween, the scariest monsters might not be in your closet or under your bed. They may be overseas, orchestrating intrusions into your electronic medical record. Or they may be lurking in your own workforce, carrying...more

You Can Check Out Anytime You Want, But You Can Never Leave: FDA Import Detentions and Recommendations to Minimize Delays

In The Eagles’ song, “Hotel California,” Don Henley sings, “You can check out anytime you want, but you can never leave.” Life science companies can try to import all they want, but that doesn’t mean the products will make it...more

Trans-Pacific Partnership Has Challenges, Opportunities for U.S. Companies

The U.S. and its 11 negotiating partners – Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam – reached preliminary agreement on October 5, 2015, on the Trans-Pacific...more

Australia Biotech Week showcases sophistication and growth

On October 9, Australia's biotech community completed its annual pilgrimage to Melbourne at the conclusion of Australia Biotech Invest 2015 and AusBiotech 2015. This year's conferences once again evidenced the primacy and...more

Data privacy in the Americas - At a glance

As multinational employers are aware, data privacy laws can vary greatly from jurisdiction to jurisdiction. Ensuring compliance with the different requirements can be challenging, and the penalties for noncompliance can be...more

Trans-Pacific Partnership: Compromise on Biologics Exclusivity Unclear

Earlier this month, a final agreement was reached on the Trans-Pacific Partnership that could provide for as little as five years of exclusivity for biologics. In recent months, it was reported that the biologics exclusivity...more

Amendments in Kazakhstan’s medicinal products registration system: new hope for rights holders

In January and June 2015 Kazakhstan’s legislation was amended in order to protect the interests of developers of new pharmaceuticals and apparatus used in healthcare....more

Washington, D.C. Update – October 2015

House Leadership Elections: Republican House leadership changes remain in flux in the wake of Speaker John Boehner's (R-OH) decision to retire and the unexpected delay of the vote to select his successor. House Majority...more

Bristol-Myers Squibb Pays $14 Million to SEC to Resolve China FCPA Offenses

On October 5, the SEC announced a settlement with Bristol-Myers Squibb to resolve allegations that the pharmaceutical company’s Chinese joint venture, BMS China, gave cash, jewelry, and other benefits to health care providers...more

Four Clear Messages from Bristol Meyers Squibb FCPA Enforcement Action

The SEC’s FCPA enforcement action for $14.6 million against Bristol Meyers Squibb (“BMS”) in China provides a textbook example of how things can go wrong in China. For the compliance practitioner (as well as CEO and...more

Africa Update - October 2015

Leading the News - Burkina Faso: On October 1st, authorities in Burkina Faso said General Gilbert Diendere, the leader behind a recent coup attempt in the country, was in the custody of security forces. According to...more

Expect Focus – International, Summer 2015

In This Issue: - TTIP’s Impact on U.S. and EU Trade Relations - Proposed Innovation Box Legislation - Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014 - Rules...more

The Oman Update - Official Gazette 1116

Ministerial Decisions - Ministry of Health - Ministerial Decision No. 124/2015 - Promulgating the regulations governing private health facilities for the treatment and rehabilitation of patients with an...more

Bristol-Myers Squibb FCPA Enforcement Action

Yesterday, the Securities and Exchange Commission (SEC) announced a Foreign Corrupt Practices Act (FCPA) enforcement action against Bristol-Myers Squibb Company (BMS) for the actions of the company’s joint venture (JV) in...more

Trans-Pacific Partnership agreement on term of data exclusivity for biological pharmaceuticals, not patent term

Five years of negotiations have culminated this week in the signing of the Trans-Pacific Partnership (the “TPP”) agreement by 12 countries from the Pacific-rim region, including the US and Australia. While the partnership...more

Africa Update - September 2015 #5

Leading the News - Burkina Faso: On September 25th, the United Nations (U.N.) Security Council issued a statement welcoming the reinstatement of President Michel Kafando and the transitional authorities of Burkina...more

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