Los medicamentos genéricos y el árido campo para sembrar la polémica

La industria de los medicamentos genéricos es una parte integral del sistema de salud de todo el mundo. Sin embargo, existe un debate en curso sobre la verdad en la industria de los medicamentos genéricos. En este artículo, se discutirán las leyes que regulan el mercado de los medicamentos genéricos, así como la realidad química de los efectos beneficiosos y secundarios de estos medicamentos.

Midjourney image

En primera instancia quien tiene cierta relación con la industria farmacéutica debería tenerlo claro pero lo cierto es que he oido a médicos cuestionarlo, si si, a médicos, en Europa en el siglo XXI. Bajo mi punto de vista este tipo de cosas, van de la mano con comentarios como que los aviones de una compañía de bajo coste son inseguros, el gran argumento es que supuestamente no pasan los mismos controles de seguridad en los aeropuertos. Ni voy a entrar en quien siembra este tipo de bulos por llamarlo de una manera menos hiriente, a los efectos da igual, es una cuestión de dejadez e ignorancia porque todos tenemos internet y con una búsqueda sobre la ley o entidad reguladora la duda queda resuelta.

Dicho esto y retomando el tema de los genéricos y centrándome en Europa, la ley cambió en 2004 donde desaparece la obligación de que el medicamento de referencia deba estar comercializado en el estado miembro en el que se pretende comercializar el medicamento genérico y se fija un único período de protección administrativa de los datos relativos al medicamento de referencia de 8 años aunque no podrán comercializarse hasta transcurridos los 10 años desde la fecha de autorización inicial del medicamento de referencia. Es decir, un laboratorio tiene 10 años para amortizar y rentabilizar un nuevo fármaco.

Leyes que regulan el mercado de los medicamentos genéricos

En Europa, la Agencia Europea de Medicamentos (EMA, por sus siglas en inglés) es la agencia responsable de la aprobación y regulación de los medicamentos, incluidos los medicamentos genéricos. La EMA requiere que los medicamentos genéricos sean bioequivalentes al medicamento de marca y cumplan con los mismos estándares de calidad, fuerza y pureza, es decir que contiene los mismos ingredientes activos y se absorbe de la misma manera en el cuerpo.

En los Estados Unidos, la FDA es la agencia federal responsable de la aprobación y regulación de los medicamentos con los mismos criterios de la EMA.

En ambos casos, la aprobación de un medicamento genérico requiere pruebas rigurosas y rigurosos estándares de seguridad y eficacia. Aunque algunos críticos argumentan que los medicamentos genéricos no son tan efectivos como los medicamentos de marca, los estudios han demostrado consistentemente que los medicamentos genéricos son igual de efectivos que los medicamentos de marca.

Realidad química de los efectos beneficiosos y secundarios de los medicamentos genéricos

La realidad química de los efectos beneficiosos de los medicamentos genéricos es la misma que la de los medicamentos de marca. Los medicamentos genéricos contienen los mismos ingredientes activos que los medicamentos de marca y, por lo tanto, tienen los mismos efectos beneficiosos. Sin embargo, los medicamentos genéricos pueden contener diferentes excipientes, que son los ingredientes inactivos que se utilizan para dar forma a la píldora, mejorar la absorción o el sabor, o para ayudar a preservar el medicamento. Estos excipientes pueden variar entre los medicamentos genéricos y de marca, pero no afectan la eficacia del medicamento. A veces esta parte es la que los escépticos toman como bandera para justificar lo incuestionable.

Por otro lado, los efectos secundarios de los medicamentos genéricos pueden ser diferentes de los efectos secundarios de los medicamentos de marca. Esto se debe a que algunos de los excipientes utilizados en los medicamentos genéricos pueden afectar la absorción y la metabolización del medicamento en el cuerpo, lo que puede afectar la probabilidad de experimentar efectos secundarios.

Para cerrar con un ejemplo, el ácido acetilsalicílico o AAS, conocido popularmente como aspirina, nombre de una marca que pasó al uso común, fue creada por Bayer en 1897, el siglo pasado ni más ni menos, es decir, el ácido acetilsalicílico es exactamente igual en todos y cada uno de los laboratorios que se produce en todo el mundo, ¿queda alguna duda al respecto?.

Rafael Cruz Núñez
Artwork Manager

Packaging Reduction: Non Food items

Electrical goods often come with warranties and usage instructions in multiple languages. You know what I’m talking about, the multiple booklets of instructions in 10 different languages or the warranty document to complete and return by post! (remember postage stamps anyone?!), that often fall straight into the recycling bin.

But, there are valid and important reasons for having these. One, being the safety of the consumer and their new product, or information on how to put your new piece of furniture together; but also, one SKU with as many languages included as possible, means a reduction in the overall number of SKUs in production. The more languages you can include, the more countries you can sell that same product in.

So, how do you go about making these important and (sometimes) required pieces of information available while considering packaging reduction and carbon footprint for example? How to squeeze 10 languages on less paper? Do we really need to print out 5 different warranty cards?

  1. A picture is worth 1000 words: Pictures are a universal language and can help convey information without the need for words. This is particularly useful for showing how to use a product or for highlighting specific parts of the product. For example, IKEA provides assembly instructions for their furniture with clear and concise illustrations and no words.
  2. Words: Words are necessary for more detailed instructions and for legal information such as warranties and safety warnings. They also allow for specific language nuances and cultural references that may not be conveyed through pictures alone. Samsung provides detailed instructions in multiple languages for their products, including safety warnings, to ensure that customers fully understand the products they purchase.
  3. Pictures: Using pictures can make the information easier to understand and remember, especially for customers who are not fluent in the language in which the instructions are written. It also saves space, making it easier to include multiple languages in the single document. Apple Inc. uses pictures and diagrams to explain the functions of their products in multiple languages, making the same information accessible to a wide range of customers.
  4. Environmental Impact: Printing documents in multiple languages can have a significant environmental impact, particularly if they are rarely read and often thrown away. Consider providing instructions and warranties in electronic format (online) where possible, to reduce waste. This aligns with companies’ efforts to reduce their carbon footprint and meet overall packaging reduction targets. For instance, Tesla provides electronic versions of their warranties and usage instructions, reducing the amount of paper waste generated by their products.

In conclusion, handling multiple languages in FMCG warranties and usage instructions requires careful consideration of the most effective way to convey information. A combination of pictures and words can be an effective solution, while also reducing the environmental impact of printing (less paper required) or by providing electronic versions where possible. This supports companies’ efforts to reduce their carbon footprint and meet overall packaging reduction targets.

What are you doing to reduce the amount of packaging and unread booklets in your product?

Challenging times for the cosmetics industry

Image generated with Midjourney

The European beauty, personal care, and cosmetics industry is being challenged at the moment, with multiple regulations and changes to earlier ones taking effect during this and coming years.

One major change happened in April 2022, with the amendment to the cosmetics regulation that affected product labelling. This change was made to ensure the safety and well-being of consumers, improve market surveillance and create a level playing field for cosmetics companies within the EU. The new regulation has set several deadlines that companies must meet by 2023.

Ingredients list

The cosmetics regulation requires companies to provide detailed information on the ingredients used in their products. Companies must list the ingredients on the product label in descending order of concentration, and provide a full list of ingredients on their websites or through a consumer hotline. This information must be available by July 2023, and will help consumers make informed decisions about the products they purchase, including any potential allergens or harmful ingredients.

In relation to this, the list of allergenic chemicals that need to appear in the label if found in fragrances or essential oils at levels greater than 0.001% for leave-on products or 0.01% for rinse-off products, was increased to 81.

Warnings

Another major change to the cosmetics regulation is the requirement for companies to provide warning and precautionary statements on their product labels. This includes information on the safe use of the product, such as the recommended usage, and any potential risks associated with the use of the product. Companies were required to provide this information by January already, and it will help consumers make informed decisions about the use of cosmetic products and reduce the risk of adverse reactions.

Non-compliance measures

In addition to the new labelling requirements, the EU has increased its resources for market surveillance to ensure that companies are complying with the new regulations. This includes unannounced inspections, random sampling, and regular monitoring of companies. The EU is expected to take enforcement action against companies that fail to comply.

There is no doubt that the recent amendment to the cosmetics regulation is a significant step forward in ensuring the safety, transparency and sustainability of the cosmetics industry in the EU. However, the changes come hand in hand with other regulations that even if not specifically crafted for it, also affect this sector. Examples of such are the European restriction on microplastics, or the EU Packaging and Packaging Waste directive – which we may address at a later time.

The amount of changes and the need to adhere to new regulations is making it essential for people in the industry to closely monitor all information around these topics and connect with key sources in order to avoid fines, and other penalties due to non compliance. In many cases, this is also leading to re-labelling/re-packaging of certain lines of products for cosmetics manufacturers.

How are you keeping up to date with all these regulations?

Are you struggling to meet deadlines when it comes to re-packaging /relabelling your products?

Do you find it difficult to confirm if your products are compliant?

If that is the case, these links may be interesting for you: