Global View: Talking Harmonization And China With Jeffrey Gren

The just-retired Commerce official Jeffrey Gren discusses the impact of globalization on the medical device industry, and the issues the sector is facing in China.

Few have more experience advocating for the U.S. device industry abroad than Jeffrey Gren, a former director at the U.S. Department of Commerce. During his 38-year stint at the department, from which he retired in January, Gren promoted U.S. device and drug exports and regulatory harmonization across countries, among other responsibilities.

Gren participated in the U.S.-China Joint Commission on Commerce and Trade (JCCT), where many important bilateral commercial issues facing the two countries are raised. He was co-chair of the meeting’s medical device subgroup, which focused on regulatory training programs based on documents and models established by the Global Harmonization Task Force (GHTF).

Prior to retirement he was the director of the Office of Health and Information Technology; previously he was director of the Office of Health and Consumer Goods and the Office of Microelectronics and Medical Equipment and Instrumentation.

Gren stressed the importance of multicountry regulatory and political forums, such as the Association of Southeast Asian Nations, the Asian Harmonization Working Party and the International Medical Device Regulators Forum (IMDRF). He said global device initiatives, such as unique device identification, are strong examples of international cooperation and coordination.

Jeff Gren during a 2013 visit to the office of the American Chamber of Commerce in Shanghai.

Photo: © AmCham Shanghai

The goal of globally harmonized regulations, or “convergence,” is not “about pushing a U.S. FDA regulatory regime,” he said.” It’s trying to have commonality in the way products are reviewed.”

The conversation with Gren centered on China, where the medtech sector is expected to reach sales of $1.7 trillion by 2022 (Also see "Global Medtech Companies Seeking Ways To Fortify Competitive Advantage In China" - Scrip, 25 Oct, 2013.).) “One of the things that I think the Chinese are very sincere about is developing a regulatory regime that is based upon global principles,” he said, adding that it is important for the country to be involved in global regulatory dialogues.

“Many of the issues that we work on are long-term issues, not something that we have a meeting on and we reach agreement on immediately. It’s really a long-term effort,” he said. Despite the concerns that he expressed during the interview, Gren said he is optimistic that progress will continue to be made to China’s device regulatory regime.

Gren emphasized that he is speaking as private citizen and that his opinions do not reflect those of the Department of Commerce. “I just need to say I’m saying ‘we’ but I’m no longer part of the federal government. It will take me a while to get over the ‘we,’” he said with a laugh.

His discussion with PharmAsia News is excerpted below.

PharmAsia News: Can you name some device-related issues that merit greater global cooperation or coordination?

Jeff Gren: Plant audits are an extremely important area. It’s an enormous cost to manufacturers to have to comply with different requirements, and there’s been some great progress on developing common practices for audits. And this has been a big issue for many years. FDA has relied on quality systems, while Europe has relied on ISO [International Organization for Standardization] 13485. There’s an IMDRF pilot that includes Brazil, U.S., Australia, Canada and Japan as an observer [ (Also see "FDA’s ISO Audit Program Chugs Along; May Be Absorbed By IMDRF Single-Audit Initiative" - Medtech Insight, 13 Jun, 2013.)] I think there are some very good things going on globally. This is an area that needs more global cooperation because no regulatory system has the resources to do all the plant inspections, and that’s one of the reasons that we’re seeing much better coordination now.

“Pricing and government reimbursement is a huge issue in China and there have been various schemes over the years attempting to reduce the prices of devices.”

PharmAsia News: What are some issues that the Department of Commerce is focusing on with regard to the China medical device market?

Gren: Country of origin has been a big issue that we’ve discussed with the Chinese. It’s a higher standard of regulatory review if the product is not made in the country of origin from the manufacturer or country of legal manufacturing [ (Also see "China's Device Classification System And Country Of Origin Requirements Weigh On Foreign Companies" - Scrip, 5 Jul, 2011.)]. And this is a problem that is not unique to China. But it’s a major problem in China. A good example would be a U.S. medical device company makes a product in Mexico that is then exported. It has FDA approval. It has a CE mark, but China is holding it to a higher regulatory standard for review because it’s a U.S. company and it doesn’t have China Food and Drug Administration approval. And many products are made for the export market only and they don’t have FDA approval if it’s not sold in the U.S. As I’m sure you are aware of, there is a serious issue on the time and cost of an FDA regulatory approval. The Chinese do take into account whether a product has an FDA or a CE mark approval as long as it meets the country of origin specifications.

Type testing is another big issue [ (Also see "American Chamber In China Calls For Streamlined Regulations For Medical Devices" - Scrip, 29 Apr, 2011.)]. Type testing is when they take samples of a product and test it in laboratories to make sure it meets regulatory specifications. [It] is really an obsolete method. Twenty years ago most regulatory regimes had type testing. Maybe we have to go back 30 years. FDA quality systems [are] a far better way of testing because you’re making sure you have consistent manufacturing at the plant level. That’s something we’ve had a lot of dialogue over with the Chinese.

PharmAsia News: China has recently agreed to reverse a proposal that would have favored domestic manufacturers by restricting access to a pending accelerated approval pathway for “innovative” medical devices [ (Also see "‘Made In China’ Provision Removed From Green Channel Policy" - Medtech Insight, 9 Sep, 2013.)]. What is your reaction to the government’s removal of the “Made in China” provision from the planned green channel review program?

Gren: It signals some improvement. It is not a full solution. Clearly, it’s been an issue for a while that there are somewhat different requirements for local China manufacturers and importers. And I’ve heard complaints from companies on both sides. Because suddenly a [foreign] company becomes a local company because they have local manufacturing and they feel that there are certain requirements that are more rigorous and others that are less rigorous.

PharmAsia News: Are companies worried about the amount of sensitive information they must give to the Chinese regulators and the protection of their intellectual property in China?

Gren: I’ve heard the same questions being asked. Regulators not just in China, but regulators in many markets ask for sensitive information as part of the regulatory approval process. There is a certain confidentiality nature to that [process]. It is clearly one of the issues that has been discussed.

IP has not been a high priority issue that we’ve been addressing on the medical devices side. It’s an important issue to industry, but when we talk about the market access issues and the issues that industry has with the China FDA, it is not one of the top issues. It’s not that there haven’t been cases of problems. It is an issue, and we have discussed it.

PharmAsia News: So, if it’s not IP, what are multinational device companies’ greatest concerns about operating in China?

Gren: Pricing and government reimbursement is a huge issue in China and there have been various schemes over the years attempting to reduce the prices of devices [ (Also see "Despite Reg Challenges, China Market Access Gradually Improving" - Scrip, 5 Oct, 2011.)]. I think there are certain practices that need to be addressed, [such as] hospital tendering [ (Also see "China’s Aim For Centralized Bidding Pressures Medical Device Industry" - Medtech Insight, 22 Oct, 2012.)]. I’m really not comfortable at this point giving concrete examples because that gets into some sensitive areas.

One thing to understand is that regulation and pricing and reimbursement are [handled by] separate ministries. China FDA, which is the group that we primarily deal with in the JCCT subgroup, is just regulatory, and they do not deal with pricing. The ministry that involves insurance ... has more involvement in pricing, as well as city and provincial governments.

Reimbursement and pricing is a very important issue for industry in other markets in the world as well.

“One of the fears is that they may develop their own [UDI] system that is unique to China.”

PharmAsia News: Any other significant areas of reform in China you would point to?

Gren: In China, they were reviewing combination products separately. It wasn’t a third category, but the devices division and the drug division each reviewed it, and often the drug review took much longer so it delayed the process. The Department of Commerce, working with AdvaMed, organized a combination products training program on the margins of a 2012 JCCT medical device subgroup meeting. Through this dialogue there’s a much better understanding of the issues, but it is not totally resolved.

One of the issues that we’ve raised is that for certain types of radiology equipment and certain types of in vitro diagnostics, China had a higher risk category than has existed in most of the developed countries, particularly the U.S. and European Union. China’s been looking into that and they’ve done some redefining of risk categories for certain products. It is one of the areas we’ve raised in the JCCT subgroup and it’s one of the areas where we’ve had some progress.

PharmAsia News: Are you anticipating Chinese participation in the global unique device identification initiative?

Gren: China has been very engaged in this. We’ve been addressing UDI at our JCCT meetings. It’s also been addressed by the Asian Harmonization Working Party. One of the fears is that they may develop their own system that is unique to China. Although when we discuss it with the Chinese they say they are moving forward with UDI, they are very interested, they are looking at the global approach, but for pharmaceuticals, China went with 1-D bar coding, instead of 2-D barcoding, which is the system that’s supported by [international standards setting body] GS1 [ (Also see "China’s State FDA Proposes Digital Monitoring For All Imported Drugs" - Scrip, 23 Oct, 2012.)].

There’s [multination] conformity on UDI. [UDI] is a really excellent example of global cooperation. China’s engaged in this discussion. And the industry concern and the U.S. concern is that when China adopts UDI for medical devices that they do it consistent with all of these activities that are going on and they use a UDI approach, which is also based on GS1 standards.

PharmAsia News: What was your greatest achievement at the Department of Commerce?

Jeff Gren: In regard to medical devices, the biggest accomplishment that I’ve personally had relates to activities to harmonize medical device [regulations] and to help developing countries establish medical device regulatory regimes that are based on the guidance documents of the Global Harmonization Task Force. When you go back 20 to 30 years, most of the world did not have medical device regimes, and there were many regimes that treated medical devices as drugs, [even though] drugs are different than devices.

The Department of Commerce has been a leader in organizing various global training programs. …The results that we’ve seen is that a lot of the world has adopted regulatory regimes that are based on GHTF guidance documents, and there are very few cases where medical devices are regulated in a similar manner as drugs. This has been a significant accomplishment.

PharmAsia News: What’s next for you?

Jeff Gren: I’m exploring post-retirement opportunities and I’d like to continue to contribute to furthering advancements in the pharmaceutical or medical device industries. I miss working right now, I really do.

[Editor’s note: This story first appeared in sister publication, “The Gray Sheet,” Feb. 24, 2013.]