Four Pharma Companies Lead in Regulatory, Legal Compliance

Posted 14 November 2016 By Zachary Brennan

placeholder+image

Gilead, Novo Nordisk, Eisai and AbbVie have been singled out as the only companies that were not found by a court or regulator over the past two years to have breached criminal or civil laws or codes of conduct related to corruption or unethical marketing, according to the 2016 edition of the Access to Medicines Index.

Background

Every two years since 2008, the Access to Medicine Foundation publishes a ranking system analyzing 20 different pharmaceutical companies against seven different categories: general access to medicine management; market influence and compliance; research and development (R&D); pricing, manufacturing and distribution; patents and licensing; capacity building; product donations.

In total, the 2016 Index used a framework of 83 metrics to measure company performances relating to 51 high-burden diseases in 107 countries.

In terms of overall rankings, the report says that GlaxoSmithKline, Johnson & Johnson and Novartis are the top three companies. The three companies at the bottom of the top 20 are Daiichi Sankyo, Roche and Astellas Pharma.

“Overall, moderate progress is visible in the pharmaceutical industry’s efforts to improve access to medicine, especially when it comes to refining the way access activities are organised, development of relevant products, waiving of patent rights in the poorest countries, and granting manufacturers licences to make generic versions of their products,” the report said.

However, the Index’s authors also call for more work to be done around pricing and developing access plans in the R&D phase so products can be more easily and widely distributed once they hit the market.

Leaders in Compliance

Of the top four companies in terms of compliance (Gilead, Novo Nordisk, Eisai and Roche (AbbVie is 8th overall in the rankings)), Gilead once again ranks first, and the Index notes that only Gilead and Novo Nordisk have avoided settlements for breaches of criminal or civil laws or regulations relating to corruption or unethical marketing in two different indices.

The latest Index praises Gilead’s high-quality system for ensuring employees comply with laws, regulations and codes of conduct, including compliance training for third-party contractors, in addition to its publishing of policy positions related to the responsible use of intellectual property and trade issues.

However, Gilead, like most other companies, is not transparent about marketing activities, the report notes.

Of a total of 51 settlements linked to a lack of compliance, the majority (31) were breaches of codes of conduct, while the 20 others were breaches of national civil or criminal law.

“Companies may be at greater risk of non-compliance in low- and middle-income countries, where regulatory systems are likely to be weaker. This underscores the need for strong enforcement of compliance systems for companies operating in these jurisdictions,” the report says.

The top four leaders in compliance are followed by a large group of seven companies (ranked 5th to 11th), all tightly clustered, including Sanofi, Johnson & Johnson and Merck & Co.

Sanofi, ranked 5th, has risen the furthest (13 positions) since the last Index, mainly due to significant improvements in its compliance system and the fact that it now conducts annual audits in its priority markets and rotational audits in other countries sensitive to risk.

The middle pack is followed by another tightly ranked group of six companies: Eli Lilly, Takeda, Bayer, Daiichi Sankyo, Novartis and Bristol-Myers Squibb, in that order.

Most in this group were the subject of civil or criminal settlements for cases of corruption or unethical marketing, though Eli Lilly and Bayer were found to have breached codes of conduct.

In terms of wrongdoing, the report highlights that Novartis was found to have breached civil laws for corruption or unethical marketing three times, including once in China, and to have breached codes of conduct four times (for cases of unethical marketing). Bristol-Myers Squibb is the biggest faller in this area of compliance: falling from 3rd to 17th place after breaching civil law in China for corruption.

“The three laggards” on compliance, according to the report, are Astellas, Boehringer Ingelheim and Pfizer, which have all been subject to civil or criminal settlements during the period of analysis for corruption or unethical marketing.

Pfizer, which occupies the last place on the list for compliance, was found to have breached laws or codes for corruption and unethical marketing more times than other companies, including in China.

Transparency

While the leaders excel in some areas of marketing and lobbying transparency, overall, the report says, companies perform poorly.

In terms of what was assessed, the Index authors look to companies’ transparency regarding memberships of associations and financial support provided, plus board seats held; transparency of policy positions; transparency of political contributions; transparency of conflicts of interest policy; transparency of marketing activities. 

The Index found that only six companies (Gilead, GSK, Johnson & Johnson, Merck KGaA, Novartis and Roche) disclose their conflict of interest policy, while GSK and Merck KGaA are the only companies to publish their policies on political contributions (GSK does not make any political contributions, including US state offices, though it has set up a Political Action Committee to enable employees to make lawful voluntary contributions, while Merck KGaA does not make any political contribution to holders of or candidates for political offices, political parties or related organizations).

In terms of clinical trials, all companies have policies to ensure they are conducted ethically, and since 2014, none have been found to breach international clinical trial guidelines.

“However, only seven companies go beyond International Conference on Harmonisation Guideline for Good Clinical Practice (ICH-GCP), by incorporating key principles of the Declaration of Helsinki into their codes of conduct (e.g., post-trial provisions, use of placebo controls, and scientific requirements and research protocols). Almost all companies provide evidence of monitoring, auditing and applying disciplinary action to ensure compliance with their codes of practice. Astellas and Gilead are the exceptions,” the report says.

Falsified Medicines and Safety

Company transparency can also help improve the planning, regulation and security of supply chains.

A key example, newly measured in 2016, is how companies report suspected cases of falsified and/or substandard medicines to relevant authorities as the World Health Organization encourages rapid reporting of suspected (i.e., unconfirmed) cases, to allow a fast response to emergencies, which is also required in the EU and other strong regulatory environments.

However, company policies vary: only two companies, AbbVie and Daiichi Sankyo, commit to reporting cases of falsified medicines to relevant authorities in less than a week.

The majority of companies also were found to update their safety labels globally, but sharing safety data is less common.

safe

In addition, AbbVie, Bayer, GSK, Johnson & Johnson and Novartis were highlighted by the report as leaders in pharmacovigilance.

The Index also measures whether companies have stringent drug-recall guidelines and whether they track products to ensure recalls can be completed efficiently.

Compared to 2014, four more companies (AbbVie, BristolMyers Squibb, Merck KGaA and Pfizer) now have product-recall guidelines in place in all of the countries where their products are available. Eighteen companies now have these guidelines, but the report singles out Novo Nordisk as the only company that publishes details of its drug recalls.

Innovative Best Practices

The report also calls out some companies that are adopting innovative compliance-management policies and practices, such as GlaxoSmithKline’s “cooling off” period for staff hired from the public sector, where such staff are not permitted to work on any project from their previous role for six months.

In terms of ethical hiring, the report points to a Takeda pilot of an ethical screening process that applies to prospective employees and consists of a questionnaire designed to identify potential areas of concerns, and scenarios for testing applicants’ ethical decision-making processes.

The report also highlights the work of Bayer from 2015, which co-founded a Special Interest Group within the International Society of Pharmacovigilance, bringing together regulatory authorities from Southeast Asia and international experts to develop and share innovative risk minimization methods and tools. The group has since developed an innovative customizable open-source tool to facilitate the development of locally-appropriate risk management guidelines.

Access to Medicines Index 2016

Correction: A previous version of this story incorrectly said that the Access to Medicine Foundation is run by the Gates Foundation. The foundation is actually an independent non-profit that in 2015 received 740,283 Euros from the Gates Foundation, 550,000 Euros from the Dutch Ministry of Foreign Affairs, 166,733 Euros from the British government and 100,000 Euros from the Dutch National Postcode Lottery. 

Share this article:

Categories: Biologics and biotechnology, Drugs, News, US, Canada, Europe, Asia, Latin America and Caribbean, Africa, Middle East, ICH, WHO

Tags: pharmacovigilance, pharmaceutical regulatory compliance, Gilead, Sanofi, Takeda, Pfizer, Novartis, Takeda, Gates Foundation, pharma regulations

Regulatory Exchange: Latest Updates From the Community