Finding a solution
We have seen both scenarios among our clients. Is this a level playing field? Is it in a company's best interest to relocate
its production to a foreign, ideally non-English speaking, country to attract less FDA scrutiny? Because of lower compliance
costs, the company's cost of production will also be lower, in addition to any other related lower costs based on the local
Considering the global nature of the pharmaceutical business and the merits of free trade, global inspection standards are
needed and should be uniformly enforced. The current supply chain has become so long that breaches are occuring more frequently,
with no end in sight. Unfortunately, a long supply chain can lead to fragmented inspection scrutiny. Should regulators discourage
such complicated production schemes under the justification that they are too risky and too difficult to control? Supply-chain
breeches cast doubt on the industry, harm its credibility, and reduce consumer confidence in products—just look at the recent
consumer angst over the H1N1 vaccine.
The International Conference on Harmonization (ICH), the Global Harmonization Task Force (GHTF) for medical devices, and the
pharmacopeia have made good progress on establishing global standards. But global standards are only as good as global enforcement,
because too much profit is available to those who cut corners. FDA has a major, but not all-encompassing, global inspection
program. The Europeans have a significant foreign inspection program.And other countries perform some foreign inspections,
but is this enough? Consider the following:
- Perhaps the countries setting the global standards also need to set global enforcement standards backed with adequate inspection
- Perhaps each country should contribute resources for enforcing compliance in proportion to its size
- Similar to the way ICH sets harmonized standards for product applications, perhaps the organization could also agree on the
depth and breadth of global inspections
- Perhaps all inspectors from around the world should have a standard amount of time to spend on site, ask the same questions,
request (and be able to understand) the same number of documents, and arrive at similar conclusions based on what they have
seen—would this require a global inspectors' training program?
- Perhaps all good manufacturing practice documents should be required to be in the local language and in one of a handful of
major world languages that would be used by the majority of inspectors.
There is precedent for developed countries to cooperate on enforcement—for example, to protect global human rights. The UN
and the North Atlantic Treaty Organization oversee such collaboration. How about an ICH Inspectorate?
Paul Larocque is president of Acerna Inc. in Ontario,