The pharmaceutical markets that currently have a serialization and/or tracing regulation on the books include the United States, the European Union, China, Brazil, India, Italy, Turkey, South Korea, Argentina, Saudi Arabia and Jordan. Not all are fully operational yet, but they are official. This list may be about to grow by two.
The Eurasian Economic Union, which includes Russia and 5 other countries, and Pakistan have circulated or published draft proposals that would each impose some form of serialization and tracing on drugs in their respective supply chains. I know this because I am a member of GS1 Healthcare’s Public Policy work group where early news and drafts of proposed legislation and regulations related to healthcare product identification are collected and shared. That group maintains a repository of the key documents, including official and unofficial translations. As a member, I cannot share documents that are not available from their original source and so far, I have not found these on the open internet. That’s not surprising since they are only proposals. They are probably in limited circulation. But I can share with you some of the proposed characteristics contained within those drafts.
The draft document is a concept paper apparently from the Government of the Russian Federation but it is unclear exactly which branch of the government it comes from. However, it is a 53 page document that contains text, tables, architectural diagrams and a few flowcharts. Clearly a lot of time and effort has gone into its development. Which is why global pharma companies should pay attention. The proposed timelines are short.
Unfortunately, translating the Russian language is difficult. I use Google Translate, but the resulting English is sometimes confusing and subject to your own further interpretation. I have heard concerns by others (who have apparently employed a professional interpreter), that the proposed regulation requires drug manufacturers to apply for serial numbered, pre-printed labels from the government, which would then be shipped to the manufacturer for application to the product. I don’t see that when I use Google Translate on the sections of the document that discuss the labeling requirements. So we have a difference in our interpretation. I guess it’s the professional vs. the machine. Which do you trust?
But it is fairly clear that manufacturers would need to apply for the serial numbers from the government, kind of like China. My interpretation is that the unique identifier would be printed on the product label by the manufacturer or CMO/CPO using a GS1 2D barcode—either a Datamatrix or a QR-Code. The “Possible structure and composition of the data 2D code” is proposed as:
- An “System Identifier”, FNC1, which is “character #22 in the ASCII table”, in accordance with ISO/IEC 16022;
- The product code registered with the Ministry of Health;
- The 14-digit Global Trade Item Number (GTIN);
- Expiry date in the format YYMMDD;
- 10-character batch number;
- “A unique identifier for the package LP (SN) – 20 characters. Formed from the production of a unique identifier (plus optionally the production line), a unique identifier of produced goods in the production units and the last check digit”.
For the most part, except for the serial number, this appears to conform to GS1 standards. The product code would need to use GS1’s National Health Reimbursement Number (NHRN) Application Identifier (AI), which is a unique AI defined by GS1 for each country that requires one (thank you Kevin Foley for the correction on this). The document does not indicate whether the batch number must be exactly 10 characters or “up to” 10 characters, and the same with the serial number (20 characters), but these fit within the GS1 lengths for these data elements (see the GS1 General Specification).
The problem is with the serial number field. GS1 specifies that serial numbers should not contain logic. That is, there should not be any sub-elements. It should just be a unique identifier. The Russian concept paper suggests that this data element might not only contain a unique identifier, but a “unique identifier of produced goods in the production units”, and optionally a production line identifier. Hopefully they will fix this to follow GS1 standards before it becomes a firm requirement. Other data, like production line, etc. should be contained within a database record associated with the GTIN+serial number.
The proposed deadlines are very aggressive. The document proposes the following dates:
- December 25, 2015 to agree on the regulatory concept, the financing and a roadmap for implementation;
- April 1, 2016 to develop and agree on the technical system design of the government repository and related systems;
- November 1, 2016 to adopt regulatory changes that would require the use of the system to track drugs through the supply chain;
- December 31, 2016 to begin the phased operation of the system. Those proposed phases are:
- January 1, 2017: “Medicines intended for people with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, hematopoietic and related tissue, multiple sclerosis, persons after organ transplantation and (or) tissues”;
- January 1, 2018: “Medicines for medical use, included in the list of vital and essential medicines, except for medicines intended for people with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, hematopoietic and related tissue, multiple sclerosis , persons after the transplantation of organs and (or) tissues”;
- January 1, 2019: “Remaining drugs for medical use”.
The purpose of this system would be similar to other regulations around the world, including reduction in criminal activities, improving recalls and withdrawals. But unlike the other pharma track and trace regulations around the world, this one includes “The establishment of effective government pricing controls in the drug market”. It would be a government monitoring system.
I can’t stress enough that this is simply a concept paper, not even proposed legislation, although this Russian press report from last week says the government has announced that they will impose mandatory labeling of drugs, referring to the same schedule as the concept paper. I can vouch for the fact that there is some significant interest in Russia and the other member states of the Eurasian Economic Union right now because over the last two weeks the number of subscriptions to RxTrace from people in those countries has surged. I am welcoming them by adding a Russian translation to essays going forward (provided by Google Translate, for whatever it is worth).
The document I have seen from Pakistan is just a discussion draft of potential amendments to their drug supply chain regulations by the Drug Regulatory Authority of Pakistan (DRAP). Those proposed amendments are still under consideration and, like any draft, may go through changes before they are adopted. The draft would mandate manufacturers and/or importers to apply a 2D Datamatrix barcode to all drug products on the primary and secondary packaging, and a linear barcode on the tertiary package.
It appears that the draft regulation would require a bunch of information in the Datamatrix barcode that would normally only be held within a database. That document is in English, but on this point it is particularly hard to figure out for sure, but my best interpretation is that the barcode would have to be encoded (the document uses the word “depict”) the following information on the primary and secondary packages:
- Serial number, randomized (optional until two years after enactment);
- Manufacturer’s name;
- Product name;
- Dosage form;
- Registration number;
- Batch number;
- Manufacturing date;
- Expiry date;
- Pack size;
- Manufacturer’s license number;
- Address of the manufacturing site(s) of the licensed premises;
- Location coordinates of the manufacturer;
I know, I know. Surely these are the data elements that would be held within a database. I must be mis-interpreting the text, but it never mentions a database and only talks about the contents of the barcode! I think the wording is just unclear, and they really mean that this information would be in a database.
The linear barcode on the tertiary packages apparently require a GTIN and a Serial Shipping Container Code (SSCC), which contains a serial number. The 2D barcode on primary packages, and the linear barcode on tertiary packages would not be mandatory until two years after enactment. But if there is no secondary packaging, then the 2D barcode on the primary package appears to be mandatory upon enactment.
The rule would apply to the “allopathic drugs including biologicals, for human and veterinary use only and shall not apply to alternate medicines, health and OTC (non-drug) products, nutraceuticals, medical devices, medical gases or radiopharmaceuticals”. The rule would “come into force for the batches manufactured after 31st day of March, 2016”.
Here is a local news report of the planned regulation. We’ll have to watch both of these proposals. I’ll let you know of any major developments.