The global pharmaceutical market is growing exponentially. The World Health Organisation (WHO) estimates that it is currently worth US$300bn and this figure is expected to rise to $400bn within just three years. Pricewaterhouse-Coopers says this could reach nearly $1.6 trillion by 2020, as a result of the rapidly rising demand for medicines in emerging markets, primarily China, Brazil, India and Russia (source: IMS Retail Drug Monitor 2013). In addition, companies are increasingly outsourcing drug manufacture throughout the development stage, including clinical trials. These factors all point to greatly increased transportation of potentially hazardous pharmaceutical and biotech products around the world, requiring complex logistics.
Companies investing millions in the development of biologics cannot afford to jeopardise their investment through shipping delays. Import licensing and other entry requirements of non-Western countries call for specialist knowledge, and biotechs in particular require a temperature-controlled supply chain, supported by labelling that meets the relevant legislation. Chemical classification that highlights the intrinsic hazard of a substance is fundamental to its safe management, handling and use.
Legislation relating to correct labelling is complex and changes frequently. There is a wide variety of regulations to take into consideration when shipping biotech and pharmaceutical products. To avoid confusion, the United Nations has devised a system of universally recognised symbols – the Globally Harmonised System of Classification and Labelling of Chemicals (GHS).
The aim of the GHS is to apply the same criteria for classifying chemicals worldwide, according to their health, environmental and physical hazards and the subsequent requirements for labelling and safety data sheets.
One particularly relevant and instantly recognisable symbol is the three interlocking circles for biohazardous substances. The WHO divides these into two categories: A: Infectious; and B: Samples (virus cultures, pathology specimens or used intravenous needles).
There are 22 separate pieces of EU legislation that refer to the Dangerous Substances Directive and the Dangerous Preparations Directive
The GHS is a non-legally binding international agreement rather than a formal treaty, and countries (or trading blocks) are still required to create and implement their own local or national legislation. Amazingly, there are 22 separate pieces of European Union (EU) legislation that refer to the Dangerous Substances Directive and the Dangerous Preparations Directive.
The new European CLP Regulation (Classification, Labelling and Packaging of Substances and Mixtures) for hazardous chemicals came into force in January 2009. Companies had until December 2010 to ensure that any labels for single substances were updated to the new regulations and, by June 2015, must do the same for mixtures.
CLP has introduced new hazard pictograms in the shape of a red diamond with a white background, which will gradually replace the familiar old orange square hazard symbols which applied under the former Chemicals Hazard Information and Packaging for Supply (CHIP) legislation. Some substances and mixtures have already been labelled according to the new legislation, but the old pictograms can still legally appear on the market until June 2017. The new pictograms are in line with the GHS, which uses the same, easily recognisable symbols but might have a different colour border or background.
CHIP has applied to suppliers of dangerous substances and mixtures for many years and will continue to be applied to mixtures until their reclassification to CLP on 1 June 2015.
Time and temperature-sensitive products: WHO sets out guidance for the transportation of time- and temperature-sensitive pharmaceutical products (TTSPPs), which is applicable in less-developed countries as well as in the industrialised world. Its experience with vaccine supply in many less-developed countries demonstrates that mandatory standards, such as rapid clearance through customs, can be achieved to avoid delays that could cause temperature excursions and place substances at risk – especially when clearance involves the opening and resealing of temperature-controlled packaging.
Internal shipping and external distribution containers should identify the product in accordance with all national and international labelling requirements, identify hazardous products and indicate the appropriate temperature and humidity ranges within which the product is to be transported or stored. In cases where TTSPPs are to be air-freighted, the package should be labelled using the standard International Air Transport Association label and temperature-sensitive symbol.
All finished drug products should be identified by label, as required by the national legislation, and bear at least the following information: the name of the drug product; a list of active ingredients showing the amount of each present and a statement of the net contents, such as the number of dosage units, mass or volume; the batch number assigned by the manufacturer; the expiry date in an uncoded form; any special storage conditions or handling precautions that may be necessary; directions for use, any warnings or precautions that may be necessary; and the name and address of the manufacturer, with details of the company or person responsible for placing the product on the market and marketing authorisation (product licence, registration certificate).
All finished drug products should be identified by label and bear specified information, as required by the national legislation
With TTSPPs so dependent on speed to market, the pharmaceutical and biotech markets rely heavily on air cargo. This presents challenges that have been addressed by a task force from the industry’s global trade association, the International Air Transport Association (IATA), which represents some 240 airlines – around 84% of global air traffic.
One of the IATA’s recommendations was a time and temperature shipping label, intended to standardise the myriad of labels applied by shippers throughout the industry, which became mandatory in 2012. This label, specific to the healthcare industry, must be affixed to shipments transported as time- and temperature-sensitive cargo, indicating on the lower half of the label the external transportation temperature range of the shipment.
For shipments carried by sea, the International Maritime Organisation has its own rules. The sea is an established route for some substances, e.g. Ventolin for asthma sufferers, which can be carried at chilled temperatures, and blood products moved as frozen cargoes. Hazardous materials must be labelled and declared and these cargoes require a trained person to assess documents, including Material Safety Data Sheets. Shippers are required to declare and label classified products correctly.
The international threat of terrorism has increased the precautions of many countries
Temperature control should be clearly specified, as should clearance by the authorities in importing countries. The international threat of terrorism has increased the precautions of many countries. For instance, the world’s largest pharmaceutical market, the US, requires shippers to submit cargo manifests for all ships destined for the country 24 hours prior to cargo loading at the port of origin.
International journeys by road through Europe are governed by the ADR Regulations (Accord européen relatif au transport international des marchandises Dangereuses par Route). Kemler ADR panels on the side of the vehicle identify the hazardous substance being carried and how to respond in the event of an accident. Good quality labelling companies will be able to supply either pre-printed or modular systems that comply with legislation in terms of weathering and ADR reflectivity requirements.
Rail movement is covered by the Regulations Concerning the International Carriage of Dangerous Goods (RID) – the European law for rail.
Legislation relating to correct labelling is complex and changes frequently
Choosing labelling products
There is no ‘one size fits all’ approach when it comes to chemical labelling and the correct specification can depend on many factors, including the varying temperatures to which it will be exposed, the material to which it should adhere and how long it needs to last. A bespoke solution using specially supplied labels or individually adapted printing software is usually the best approach for the pharmaceutical and biotech industries.
Growing markets and increasing globalisation in the pharmaceutical and biotech industries present challenges in terms of complex transportation logistics and frequently changing international and national regulations, but also open up immense possibilities. Hibiscus continuously monitors these changes to legislation, with the aim of allowing clients to concentrate on core business and to maximise those opportunities.
