On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
The Australian pharmaceutical industry association introduces self-regulation requirement to disclose payments to healthcare professionals and consumer organisations
The new Code introduces a requirement for the members of Medicines Australia to publicly disclose the aggregate amount of payments made to healthcare professionals and consumer organisations. The new Code has been submitted for approval by the Australian Competition and Consumer Commission. A copy of the Code is available here.
According to the new rules, the members of Medicines Australia should publically disclose:
- all payments made to healthcare professionals for their participation in advisory boards;
- all payments made to healthcare professionals for consultancy services;
- all payments made to speakers delivering presentations at educational events on behalf of the members of Medicines Australia;
- all sponsorship granted to healthcare professionals to attend medical conferences and educational events;
- all sponsorship granted to individual consumer organisations on an annual basis, including non-monetary support.
Members of Medicines Australia should disclose the above information using the disclosure forms provided in the Appendixes to the Code. It is unnecessary to identify individuals who have received or benefitted from funding. However, information including the professional status of recipients, the total amount of Honoraria provided and the total cost of any event must be provided. The first public disclosures will be published on the website of Medicines Australia in June 2013.
The new rules amplify existing disclosure obligations. However, members of Medicines Australia have already been required to publicly disclose information regarding the hospitality that they have provided at educational events. This information is published on the website of Medicines Australia.
The new requirements introduced by the Medicines Australia Code of Conduct are reflected in both laws and Codes of conduct adopted in the European Union and the US.
The Code of Practice adopted by the Association of British Pharmaceutical Industry (ABPI) requires the members of the ABPI to publicly disclose the total annual amount of sponsorship provided to healthcare professionals attending meetings organised by third parties, as well as the total number of recipients and meetings funded. ABPI Members should also publicly disclose the total annual amount of fees paid to healthcare professionals acting as consultants for the company and the total number of consultants engaged for these activities. The public disclosure should be made annually on the website of the company. The ABPI Code also imposes an obligation to disclose some interactions with patient organisations and associations of healthcare professionals. The ABPI Code and additional information are available here.
At the end of 2011, the French Parliament adopted a new law imposing a number of public disclosure requirements on companies involved in the life sciences sector. The Decree defining the scope of information to be disclosed and the related disclosure mechanism is expected to be adopted on 1 August 2012 at the latest. The disclosure requirement may, however, be applied retroactively to all agreements concluded after 1 January 2012 and to all benefits granted after 1 January 2012.
As a result of the new law, pharmaceutical companies will be required to publicly disclose the existence of agreements concluded with counterparts involved directly or indirectly in the healthcare sector in France. These include healthcare professionals licenced to practice in France, healthcare professionals' associations, organisations providing training to healthcare professionals, hospitals, patient associations, foundations, societies, external advisors and consultancies active in the healthcare sector. Pharmaceutical companies will also be required to disclose all benefits in kind or cash provided to these individuals or entities. This includes gifts and hospitality.
In March 2010 a new section in the US Social Security Act was introduced by the Patient Protection and Affordable Care Act of 2010 (PPACA). This new section imposes two annual disclosure obligations on manufacturers of medicinal products, medical devices and medical supplies. The first disclosure requirement covers, with limited exceptions, payments and other transfers of value made to physicians and teaching hospitals. Manufacturers of medicinal products, medical devices and medical supplies, as well as group purchasing organisations (GPOs) are also required to disclose information about ownership or investment interests held by a physician or a physician's immediate family member in the manufacturer or the GPO. The disclosure requirements were scheduled to go into effect as of 1 January 2012, but due to delays in implementation, manufacturers’ obligations to track payments will not begin until at least 1 January 2013. The PPACA is available here. Additional information concerning the implementation of the disclosure requirement is available here.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017