The 3rd law amending the German Medicinal Products Act came into effect on August 13, 2013.
The new regulations are mandatory for all non-interventional studies with start dates:
- later than 12 Aug. 2013,
- earlier than August 2013 and with an end date later than 31 Dec. 2013.
Even before the coming into effect of the current amendment of § 67 AMG, initiators of observational studies were required to inform KBV and GKV of the amount of contributions made to participating doctors’ fees, provided that these doctors services were at the expense of the statutory health insurance.
However, from the legislator’s perspective there was not always congruence between the contractually agreed remuneration and the remuneration actually paid.
Therefore, the new Art. 67 AMG requires the disclosure of “the actual” compensation paid, paragraph 6 sentence 4 AMG.
As already determined in the previous version of the law, the fees paid to the doctors are to be transmitted associating the lifelong physician’s identity number (for members of the statutory health insurance, “Vertragsärzte”).
In the final report to be submitted to the competent federal authority in accordance with Art.67 par. 6, sentence 7 AMG and its publication pursuant to sentence 10, the naming of the participating physician is only permitted with the physician’s prior consent (section 4a of the Federal Data Protection Act).
The most important changes aim at the disclosure of the actually paid fees for a physician’s participation in an observational study and at the reporting requirements for the fees and any payment updates after study start.
The sponsor must also explain the appropriateness of the proposed fees in the contract template between sponsor and physician/site.
Article 67 par. 6 set 5 AMG requires the initiator of an observational study to submit all changes pursuant to sentence 4 within four weeks after the end of each quarter.
Click here for more information…NIS-Reporting-Requirements_Germany_inVentiv-Health-Clinical
- Mark Heinemann, Senior NIS Submissions Specialist, Late Stage Department, inVentiv Health Clinical