Tier 1 Countries

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Tier 1 Countries 2017-08-25T19:30:13+00:00

Tier 1 Countries

Tier 1 countries are important for a number of reasons, not the least of which is their role in the exportation of biomedical products which have not yet received U.S. FDA approval for use within the United States.

The following is a brief explanation of Tier 1 countries.

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The U.S. FDA (Food & Drug Administration) has jurisdiction over the export of unapproved medical products intended for use in foreign countries. 9

The export of such products follows a two-tiered system, depending on the target country, and is subject to the provisions set forth in Chapter VIII of the U.S. Federal FD&C Act (also known as the Federal FDCA: the Food, Drug, and Cosmetic Act of 1938, and all subsequent amendments), with particular attention given to sections 801 and 802. 7, 14

Chapter VIII of the Act addresses the FDA’s regulation of both the import and export “of foods, drugs, cosmetics, biologics, medical devices, and radiation-emitting electronic products.” 6  Section 802 identifies what would later come to be known as “Track 1” and then “Tier 1” countries: those countries to which the U.S. may export unapproved drugs, including biological products and APIs (active pharmaceutical ingredients), or medical devices, intended for investigational or commercial use in those countries and in accordance with the laws of the countries, in anticipation of market authorization.7 Such drugs, biological products, and medical devices exported to Tier 1 countries do not require FDA approval nor are they required to comply with U.S. IDE (Investigational Device Exemption) regulations. 6, 8

Some of the relevant provisions of the 1938 Act date back to a previous Act from 1906. According to the FDA, “The [1938] Act’s export provision originated in 1906 as part of the Federal Food and Drugs Act (Public Law 59-384). … This export provision was included, with some modifications, in the Federal Food, Drug, and Cosmetic Act of 1938 (Public Law 75-717) where it was codified as section 801(d).” 1, 14

To remedy some inconsistencies that arose between the two Acts, as the FDA explains, “Congress enacted the Drug Export Amendments Act of 1986 (Public Law 99-660). For human drug products and biological products, the 1986 Amendments created section 802 of the Act and established three separate ‘tracks’ for exporting unapproved drugs and unlicensed biological products. … Exports under ‘track 1’ were confined to 21 specific countries listed in section 802 of the Act. Those countries were: Australia, Austria, Belgium, Canada, Denmark, the Federal Republic of Germany, Finland, France, Iceland, Ireland, Italy, Japan, Luxembourg, the Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, and the United Kingdom.” 2, 14

In order to address some of the criticism and debate that arose over the Drug Export Amendments Act of 1986, Congress enacted the FDA Export Reform and Enhancement Act of 1996 (Public Law 104-134, and amended by Public Law 104-180), specifically addressing chief concerns regarding human drugs and biological products.3 Among other reforms, the new Act of 1996 “Significantly expanded the list of countries to which unapproved products can be exported without prior FDA approval,” and it also “provided administrative mechanisms for the Secretary of Health and Human Services to add countries to the list and for the FDA to permit exports of specific products to unlisted countries.” 3, 12, 14

Thus the original list of 21 countries expanded to 25, and these “Track 1” countries began to assume the label of “Tier 1” countries.

As the FDA explains, “The principal provision authorizing the exportation of unapproved new drugs, biological products, and devices is section 802(b)(1)(A) of the [1938] Act. Section 802(b)(1)(A) of the Act states that a drug or device ‘may be exported to any country, if the drug or device complies with the laws of that country and has valid marketing authorization by the appropriate authority’ in Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, or any member nation in the European Union or the European Economic Area. … The number of ‘listed countries’ expands automatically as countries become members of the EU or the EEA.” 4, 14

The last line, above, allows for the automatic inclusion of new countries onto the Tier 1 list, as member nations are added to the EU or EEA. Indeed, as of this writing, the current number of Tier 1 countries is 38, precisely because of the ongoing addition of new EU member nations over the years.

FDCA § 802(b)(1)(A) lists the approved “Tier 1” (as they were later called) countries; the remainder of subsection (b) details the process by which the Secretary of Health and Human Services may add other countries to the list. As the FDA points out, “The 1996 Amendments contained a mechanism whereby the Secretary may add other countries to the list, provided that the country meets certain criteria. … Under section 802(b)(1)(B) of the Act, the authority to add countries to the list rests solely in the Secretary of Health and Human Services. Thus, the FDA has no authority to add countries to the list.” 5, 14

All countries not identified as “Tier 1,” known simply as “non-Tier 1 countries,” are governed by the separate set of requirements as detailed in section 801 of the Federal FDCA. It should be noted that either FDA authorization or compliance with U.S. IDE regulations are required for exportation to non-Tier 1 countries. 9

As detailed in the FDA Export Reform and Enhancement Act of 1996 and quoted above, Tier 1 countries are defined as Australia, Canada, Israel, Japan, New Zealand, South Africa, and Switzerland, plus those countries in the European Union (EU) as well as those in the European Economic Area (EEA). 10, 11, 12, 13, 14

The EU is an economic and political alliance of (at the time of this writing) 28 countries. The current EU countries, in alphabetical order, are:

1/ Austria
2/ Belgium
3/ Bulgaria
4/ Croatia
5/ Republic of Cyprus
6/ Czech Republic
7/ Denmark
8/ Estonia
9/ Finland
10/ France
11/ Germany
12/ Greece
13/ Hungary
14/ Ireland
15/ Italy
16/ Latvia
17/ Lithuania
18/ Luxembourg
19/ Malta
20/ Netherlands
21/ Poland
22/ Portugal
23/ Romania
24/ Slovakia
25/ Slovenia
26/ Spain
27/ Sweden
28/ UK

This list of EU countries will remain the same through March 28th, 2019. As of March 29th, 2019, however, and thereafter, the United Kingdom will no longer be a member of the EU; the 2-year Brexit process which began on March 29th, 2017 will be completed on Friday, March 29th, 2019, the day the UK will have officially and completely left the EU. Thereafter, the EU will consist of 27 countries, i.e., all of the above, minus the UK.

The EEA includes EU countries and also the following: Iceland, Liechtenstein, and Norway.

Hence, until March 29th of 2019, EU + EEA members will consist of 31 countries:

1/ Austria
2/ Belgium
3/ Bulgaria
4/ Croatia
5/ Republic of Cyprus
6/ Czech Republic
7/ Denmark
8/ Estonia
9/ Finland
10/ France
11/ Germany
12/ Greece
13/ Hungary
14/ Ireland
15/ Italy
16/ Latvia
17/ Lithuania
18/ Luxembourg
19/ Malta
20/ Netherlands
21/ Poland
22/ Portugal
23/ Romania
24/ Slovakia
25/ Slovenia
26/ Spain
27/ Sweden
28/ UK

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29/ Iceland
30/ Liechtenstein
31/ Norway

Add to the above list the following countries, as identified by the FDA Export Reform and Enhancement Act of 1996: 1, 4, 14 

1/ Australia
2/ Canada
3/ Israel
4/ Japan
5/ New Zealand
6/ South Africa
7/ Switzerland

Therefore, Tier 1 countries currently consist of the following 38 nations (in alphabetical order):

1/ Australia
2/ Austria
3/ Belgium
4/ Bulgaria
5/ Canada
6/ Croatia
7/ Republic of Cyprus
8/ Czech Republic
9/ Denmark
10/ Estonia
11/ Finland
12/ France
13/ Germany
14/ Greece
15/ Hungary
16/ Iceland
17/ Ireland
18/ Israel
19/ Italy
20/ Japan
21/ Latvia
22/ Liechtenstein
23/ Lithuania
24/ Luxembourg
25/ Malta
26/ Netherlands
27/ New Zealand
28/ Norway
29/ Poland
30/ Portugal
31/ Romania
32/ Slovakia
33/ Slovenia
34/ South Africa
35/ Spain
36/ Sweden
37/ Switzerland
38/ United Kingdom

Even though the UK will no longer be an EU member as of March 29th, 2019, it is nevertheless presumed, however, that the UK will still be identified as a Tier 1 country after that date — whether from special inclusion by the U.S. Secretary of Health and Human Services, or by formal amendment to the Federal FDCA, in accordance with previous precedent in which the UK was originally identified in earlier versions of the provisions associated with the U.S. Federal FDCA § 802(b)(1)(A). 6, 14  The details of post-Brexit UK inclusion have yet to be worked out.

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References

For more information on Tier 1 countries, please see the following resources, all but three of which are from the website of the FDA.

1/ “Exports Under the FDA Export Reforms and Enhancement Act of 1996,” Section IV(A), “Historical Background — Exports of Drugs and Biological Products That May Not Be Sold in the United States,https://www.fda.gov/regulatoryinformation/guidances/ucm125799.htm#drugs

2/ Ibid., Section IV(A).

3/ Ibid, Section IV(D), “Enactment of the FDA Export Reform and Enhancement Act of 1996.”

4/ Ibid, Section VII(D), “Exports of Unapproved Drugs, Biological Products, and Devices Under Section 802(b) of the Act; Exports of Unapproved New Drugs, Biological Products, and Devices to a Listed Country – Section 802(b)(1)(A) of the Act.

5/ Ibid., Section VII(E), “Exports of Unapproved Drugs, Biological Products, and Devices Under Section 802(b) of the Act; Expanding the List of Countries in Section 802(b)(1)(A) of the Act.

6/ “Exporting Unapproved Devices” (this list of EU countries omits Croatia, which did not receive EU membership until July 1st, 2013), n.b. section on “Exporting for Investigational Use”: https://goo.gl/vTJx8D

7/ “Federal Food, Drug, and Cosmetic Act, As Amended,” July 1993 (this contains the original list of only 21 approved countries), pp. 215-16: https://goo.gl/EuMaSp

8/ “Device Advice: Investigational Device Exemption”: https://goo.gl/3wV9uu

9/ “Import and Export of Investigational Devices,” see section under “Export”; see also section under “Non-tier one countries” (last updated 03/14/2017): https://goo.gl/BQrpx6

10/ “Importation of Active Pharmaceutical Ingredients (APIs) Requirements FD&C Act 802 [21 USC 382] Exports of certain unapproved products,” APIs Requirements FD&C Act 802, part (b), paragraph(1)(A), clauses (i & ii): https://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ucm118013.pdf

11/ Footnote 38, p. 7 (154), of the 22-page document entitled “Food and Drug Law Journal – Analyzing the Laws, Regulations, and Policies Affecting FDA-Regulated Products,” Volume 64, No. 1, 2009.

12/ “The FDA Export Reform & Enhancement Act of 1996” (this is an archived, unmaintained document, referring only to 25 countries, prior to EU expansion that occurred through 2013): http://www.regulatory.com/forum/article/fda_export.html

13/ “Export Certificates for Medical Devices,” p. 22: https://www.fda.gov/downloads/training/cdrhlearn/ucm234354.pdf

14/ “Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996,” https://goo.gl/HTPPyR