Upcoming changes in pharmaceutical packaging
Our expert's opinion
"It’s interesting to see the changes that can be expected in pharmaceutical packaging in the coming few years. First of all, the adherence needs to get improved, meaning the packaging will help to both take the medicine in a better, but also a safer way. Tracking, reminders, child-friendly packages, … this could be interesting to keep an eye on.
Secondly, I think it’s safe to say we were all expecting quite some changes or challenges, due to the possible Brexit – which will now be unavoidable, either by a deal or by no deal. In case of a no-deal Brexit, all approvals will need to go through the MRHA instead of the EMA, which will have an impact on laws for packaging systems, labelling and information in order to meet the requirements of the EMA. The Brexit could have a serious impact on the supply chain as well, as the UK is a significant exporter of medicinal products. Border delays – which could mean that a big part of the time and temperature sensitive goods will be unsellable – could cause the stakeholders to take their business elsewhere.
A third interesting change is the mandatory serialization of pharmaceutical goods which will tackle counterfeiting. These will mostly be in the form of digital watermarks which will be invisible to the human eye.
Biologics, being the future of medicine, bring us a fourth possible change to packaging. Biological medicines can’t be mass produced, are temperature sensitive and vulnerable to contamination. This makes packaging a big challenge as they can’t really use the popular packaging materials.
And last but not least, the future needs to be eco-friendlier, meaning there will need to be a shift to more sustainable materials and banning as much plastics as possible. 3D printing could also have its place in this, as it uses only the exact amount of packaging needed.
What do you think about these 5 interesting changes brought by Rich Quelch?"
- Alaana Pirolo, Associate Consultant
Pharmaceutical packaging - What to expect in 2019
Parmaceutical packaging is an industry going from strength to strength and its shows no signs of slowing down. In fact, by 2025 the market is expected to be worth $128 billion.
The main drivers of this growth are: increased global demand for medication from emerging economies; an ageing population; an increase in chronic diseases; antimicrobial resistance and stricter environmental and medical regulation.
Rich Quelch, Global Head of Marketing at Origin, previews the pharma packaging innovations and challenges we can expect to see in 2019.
A key priority for the pharma packaging industry will be to continue to support the wider health sector in promoting medication adherence.
With around 200,000 people in the EU alone dying each year from not properly adhering to medical advice, global health services are beginning to feel the economic strain.
Smart packaging - like technology to track and accurately monitor dosage information and give patients timely reminders – is the future of pharma, increasing patient compliance and providing valuable digitised feedback to healthcare professionals.
It can also help solve problems of unauthorised access to medicines, including promoting child-resistance. Tamper-evident packaging and pre-filled syringes are examples of innovations expected to become more mainstream.
Pharma packaging brands could reap the rewards of pioneering child-friendly packaging. With some companies achieving child-resistance levels of F4 to F1, attitudes are changing. F8 will become less unacceptable and those leading the way in terms of safety will see rising demand.
The fallout from Brexit
The UK is set to officially leave the EU – with or without a deal – on March 29th, causing disruption across the global pharma industry.
Whatever the final terms of Brexit, UK pharma firms won’t be able to act as ‘co-rapporteurs’ in the marketing authorisation process of EU products anymore.
Also, products marketed in the UK which are currently approved by the European Medicines Agency (EMA), will become the responsibility of the Medicines and Healthcare Products Regulatory Authority (MRHA) in the case of a no-deal agreement.
Consequently, new laws and systems for packaging, labelling and patient information leaflets will need to be made in order to meet the requirements and safety standards currently set by the EMA. Any divergence could lead to the demand for the duplication of facilities and roles to enable access to products, costing companies millions to establish and maintain.
Britain’s exit from the EU will likely affect the global pharma packaging supply chain too, as the UK is a significant exporter of medicinal products. Import and export tariffs would lead to a “double charge”, costing more for stakeholders and possibly seeing them take their business elsewhere.
Another concern is the possible border delays that could occur in the possibility of a no-deal Brexit. Many medicines are time and temperature sensitive, and hold-ups at borders could see large stock become unsellable. Consistent delays would mean new ways of transporting and storing goods would have to be considered, with packaging innovation playing a key role.
Counterfeit pharmaceuticals is the world’s largest fraud market, worth over $200 billion per year and it’s not just the matter of lost earnings for legitimate manufacturers that’s the issue.
Those consuming fake products have no guarantee what they’re taking is what it claims to be, which in some cases can contribute to the spread (rather than cure) of illnesses and antimicrobial resistance.
In a bid to tackle counterfeiting, a new EU law will come into play this February, making digital mass serialisation a compulsory part of pharma manufacturing. This involves random, pseudo codes being generated for each product and verified on the databases of supplier companies before going to market.
Digital watermarks will also become more widely used, offering an extra layer of protection by providing invisible, encoded data on packaging that can only be verified by specialised software. It can be captured using webcam, mobile phones and other scanning equipment, but is invisible to the human eye.
Keeping pace with biologics
Biologics are undoubtedly the future of medicine. These complex medicines aren’t like traditional drugs as they aren’t chemically synthesised and so can’t be mass-produced. As such, biologic medicines can only be produced in small batches.
They’re also temperature sensitive and vulnerable to contamination, making packaging design more difficult as it must stop any contamination or degradation. Traditional materials like glass, plastics and rubber aren’t suitable materials, due to the ability of metals to be extracted, which could degrade the biologic protein structure.
For this reason, we’ll see a greater use of fluoropolymers and cyclic olefin plastics, which don’t use any degradable stabilising agents and therefore provide a protective barrier between the product and environment.
However, as biologics differ so much in structure, we won’t see mass production of generic biological packaging, instead tailored products will be the priority. For example, materials like silicon oil – typically used to lubricate plungers in pre-filled syringes – can cause protein aggregation, so for biologics we can expect individual testing to occur for each medicine.
An eco-friendly future
The use and wastage of plastic across the pharma supply chain will continue to be a major focus in 2019, following a warning by the UN our oceans will contain more plastic than fish by 2050 unless all industries take action.
The future of pharma packaging will see a shift towards more sustainable materials, moving away from plastic which the industry has been so heavily reliant on for design and manufacturing.
Attempts to limit plastic waste will see the continued application of polyethene terephthalate (PET), which can be broken down to molecular level and converted back into PET. Now the technology has proven successful in early testing, we’ll start to see it move into global production.
New techniques are also making it widely possible to reduce waste. For example, 3D visualisation techniques eliminate the need for multiple prototype designs and computer-aided manufacturing like 3D printing uses only exact materials, minimising waste.
Source: Packaging Europe