Life Science Compliance Update

August 14, 2017

Sunshine Act Takes Effect in South Korea

South-Korea-Internship-Information

In early 2017, South Korea joined the global transparency movement and enacted a “Sunshine Act” similar to others found around the world. The law requires pharmaceutical and medical device companies operating in South Korea to prepare an aggregated expenditure report if they have provided economic benefits to healthcare professionals and others employed at medical institutions during a fiscal year.

Interestingly, while the scope of the Korean Sunshine Act is broader than the United States law, it does not require companies to submit the aggregated report and any supporting documents to the government unless it is determined to be necessary by the Minister of the Ministry of Health and Welfare of Korea. Therefore, it follows that the collected data will not be made public.

The covered recipients for Korean Sunshine Act can be categorized into four groups: (1) pharmacists; (2) herbalists (including persons working for the relevant pharmacy); (3) “medical personnel”, which includes physicians, dentists, acupuncturists, midwives, nurses); and (4) medical institution founders (including the representative, director and other employees of a juristic person) or persons working for the relevant medical institution for the purpose of sales promotion, such as adoption of drugs or inducement of prescription.

Types of reportable economic benefits include:

  • Product samples;
  • Academic conference sponsorships;
  • Honorarium provided to a covered recipient for conducting post-marketing surveillance (PMS) (equivalent to phase 4 clinical trials in US);
  • Funding of clinical trials;
  • Food and beverages and other “freebies” (such as pens, notepads, etc.) provided at the product presentations; and
  • Discounts on drug or medical device sales made with certain payment methods.

The Ministry released seven templates for the Report for all reporting categories:

  • Provision of samples – including institution, product information, and date of provision;
  • Sponsorship to academic conferences – including conference info and support funds amount;
  • Support for clinical trials – including trial information, contact, joint investigator’s info, and support details (TOV amount, number/volume of product supported, contracting date);
  • Product presentations
  • Presentations held formultiple medical institutions: product info, HCP name and medical institution, TOV amount including travel, lodging, food and beverages, and other “souvenirs” or giveaways (e.g. pens, notepads, etc.)
  • Presentations held at a single medical institution: product info, medical institution info, HCP name, TOV amount (food and beverages) and date;
  • Post-market surveillances (PMS) – including product info, HCP info, and support details; and
  • Price discounts based on payment conditions – including medical institution info, contracting date, and discount rate

For the product presentations, the reporting threshold for food and beverages, as well as other “souvenirs” or giveaways is 10,000 won (roughly $9). For all other types of transfers of values, there is no minimum threshold amount triggering the reporting obligation, and they should all be recorded in the applicable reporting template.

The reports must be kept for five years, along with supporting documentation. Companies are required to start collecting expenditure information on January 31, 2018. The report and supporting documentation must then be prepared within three months following the end of the company’s 2018 fiscal year. For example, if Company A’s 2018 fiscal year ends December 2018, then the report must be prepared by March 2019. If Company B’s 2018 fiscal year ends in March 2019, then the report must be prepared by June 2019.

A reporting template was issued in June 2017, and can be found here. Life sciences companies operating in South Korea will need to create a clear and efficient process and system to ensure they meet these difficult reporting requirements.

Special thanks to Polaris a Quintiles-IMS Company for the tip and the analysis. www.polarismanagement.com and the Korean Ministry of Health and Welfare www.mohw.go.kr/eng/

 

 

 

August 09, 2017

EU Court Issues Over-Reaching Ruling on Vaccines

Vaccine

In June 2017, the Court of Justice of the European Union ruled that courts may consider vaccines to be the cause of an illness, even if there is no scientific evidence confirming a link. The Court said that if the development of a disease is timely to the person’s receiving a vaccine, it may serve as enough proof – provided that the person was previously healthy with a lack of history of the disease in their family and if a significant number of disease cases are reported among people receiving a particular vaccine.

The ruling stemmed from the case of a French man known as J.W., who was vaccinated against hepatitis B in 1998 and developed multiple sclerosis a year later. Multiple sclerosis is known to scar nerve tissue and cause a range of symptoms, from vision problems to paralysis. In 2006, J.W. sued pharmaceutical company Sanofi Pasteur, which produced the vaccine, blaming it for his decline in health. J.W. died in 2011.

The case was brought before the Court of Appeal in France, which ruled that there was no scientific consensus supporting a causal link and no evidence of a causal link between the hepatitis B vaccine and the man's multiple sclerosis, therefore dismissing the action. This judgment was appealed and brought to the French Court of Cessation, which took it to the European Court of Justice.

The Court of Justice said that "specific and consistent evidence" relating to timeliness, a prior healthy status, lack of family history and multiple cases may prove to be enough, according to a statement. J.W.'s case referred to the first three criteria.

While the court's decision is not a ruling on J.W.'s case, it is meant to provide guidance for all EU courts considering similar issues.

In a statement, a representative from Sanofi Pasteur said: "It is not our role to comment on this legal decision. However, Sanofi Pasteur wishes to reiterate that its vaccines are safe and effective and protect against infectious diseases. Our hepatitis B vaccines are safe and well tolerated. They have been approved by Health Authorities and are marketed for more than 30 years."

Expert Statements

"No causal link exists" between the hepatitis B vaccine and multiple sclerosis, "but a few cases after vaccination would not be surprising, especially when administered to teenagers, just before the age of onset age for many MS sufferers," said Keith Neal, emeritus professor in the epidemiology of infectious diseases at the University of Nottingham. "What they are saying is, the vaccine is responsible for the patient's MS if it can't be proved it isn't, and that is virtually impossible given what is worded. Potentially, this ruling affects all drugs and threatens the development of new drugs."

Peter Openshaw, president of the British Society for Immunology and professor of experimental medicine at Imperial College London, said, "it is very concerning that the European Court of Justice has ruled that judges can consider whether a vaccination led to someone developing a medical condition, even if there is no scientific evidence to support this."

"The scientific evidence does not support a link between the hepatitis B vaccine, or any other vaccine in current use, and multiple sclerosis," he said. "To say that there is a link between any vaccine and multiple sclerosis and at the same time to admit that there is no scientific evidence of such a link is illogical and confusing to the public."

"The only alleged evidence that would be worth taking seriously is the alleged numbers of other similar cases," he said. "Those data should be capable of detailed case comparisons for consistency, and probably also orthodox epidemiological study."

But without such a study, Fox added, "one might just as well say, 'If this vaccine causes MS, then why is it that millions of people have been vaccinated and did not get MS? And why are there so many people with MS who have never had this vaccination?' "

May 19, 2017

Changing the Rules Again: The MedTech Europe Code & Third-Party Educational Support

Know-the-rules

Although the new code of conduct for member medical device and in-vitro diagnostic companies operating in the European marketplace has come into force the first day of this year, a grace period has been granted before new principles become effective. This article reviews the changes medical device and in-vitro diagnostic companies should consider implementing to adhere to the new principles for third-party educational support set forth by the MedTech Europe Code.


MedTech Europe Code of Ethical Business (“Code”) will become effective on January 1, 2018. Now with only seven months left in the Transition Period, it is a good time to examine how medical device and in-vitro diagnostic companies have been preparing. While most the standards and requirements are not new to Member Companies (“Companies”), the Code introduces several updates, which include:

  • a ‘fifth principle’ of holding image and perception of the industry in high regard,
  • new chapters with consolidated definition of events and demonstration products, and
  • changes around the support of third-party educational conferences, which will be the focus of this article.

Although the constant need to adapt to regulatory change is nothing new to those operating within the compliance space, many would agree that transitioning everyday business operations to comply with new requirements is easier said than done. This article will summarize the key changes the Code requires around educational conference support and provide some insights and considerations for in-house ethics and compliance functions.

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