Pharma Transparency

Pharma Transparency Campaign

The global organizations and populists who aim to seize COVID vaccine tech and IP

When Donald Trump claimed in September 2020 that every American would have access to vaccines by April 2021, his comments received scorn. The Washington Post said his claims were “without evidence,” CNN quoted health experts who said it was impossible, and The New York Times claimed it would take another decade.

Now, a year into this pandemic, nearly half of the eligible population has received at least one vaccine dose in the U.S., and distribution has been opened to every American adult.

Operation Warp Speed, which invested tax dollars and helped reduce bureaucracy across the board, has contributed to what has truly been a miraculous effort by vaccine firms.

While Trump’s proclamations eventually become true and the question of vaccine ability has been settled, there is now pressure on the Biden administration to turn over domestic vaccine supply to countries with skyrocketing cases.

On Sunday, the U.S. declared it will send additional medical supplies to India, currently experiencing the largest global spike in cases.

But at international bodies, countries and activist groups are petitioning for far more: they want to force biotech companies to waive intellectual property rights on vaccines and COVID-related medical technology.

Along with nearly 100 other countries, India and South Africa are the architects of a motion at the World Trade Organization called a TRIPS Waiver (Trade-Related Aspects of Intellectual Property Rights).

If the waiver is triggered, it would ostensibly nullify IP protections on COVID vaccines, allowing other countries to copy the formulas developed by private vaccine firms to inoculate their populations and play into the hands of future governments more hostile to private innovation.

This week, U.S. Trade Representative Katherine Tai met with the heads of the various vaccine makers to discuss the proposal, but it is uncertain if the Biden administration will support the measure at the WTO.

While many companies have voluntarily pledged to sell them at cost or even offered to share information with other firms, this measure would have more far-reaching implications.

This coalition seeking the TRIPS waiver includes Doctors Without Borders, Human Rights Watch, and World Health Organization Secretary-General Tedros Adhanom Ghebreyesus, who first backed this effort in 2020 before any coronavirus vaccine was approved.

They claim that because COVID represents such a global threat and because western governments have poured billions in securing and helping produce vaccines, low and middle-income countries should be relieved of the burden of purchasing them.

Considering the specialized knowledge needed to develop these vaccines and the cold storage infrastructure required to distribute them, it seems implausible that any of this could be achieved outside the traditional procurement contracts we’ve seen in the European Union and the U.S.

That said, rather than celebrating the momentous innovation that has led to nearly a dozen globally-approved vaccines to fight a deadly pandemic in record time, these groups are trumpeting a populist message that pits so-called “rich” countries against poor ones.

Intellectual property rights are protections that help foster innovation and provide legal certainty to innovators so that they can profit from and fund their efforts. A weakening of IP rules would actively hurt the most vulnerable who depend on innovative medicines and vaccines.

If the cost of researching and producing a COVID vaccine is truly $1 billion as is claimed, with no guarantee of success, there are relatively few biotechnology or pharmaceutical companies that can stomach that cost.

BioNTech, the German company headed by the husband-wife team of Uğur Şahin and Özlem Türeci that partnered with Pfizer for trials and distribution of their mRNA vaccine, was originally founded to use mRNA to cure cancer.

Before the pandemic, they took on massive debt and scrambled to fund their research. Once the pandemic began, they pivoted their operations and produced one of the first mRNA COVID vaccines, which hundreds of millions of people have received.

With billions in sales to governments and millions in direct private investment, we can expect the now-flourishing BioNTech to be at the forefront of mRNA cancer research, which could give us a cure. The same is true of the many orphan and rare diseases that do not otherwise receive major funding.

Would this have been possible without intellectual property protections?

Moderna, for its part, has stated it will not enforce the IP rights on its mRNA vaccine and will hand over any research to those who can scale up production. The developers of the Oxford-AstraZeneca vaccine have pledged to sell it at cost until the pandemic is over.

While this should smash the narrative presented by the populists and international organizations who wish to obliterate IP rights, instead they have doubled down, stating that these companies should hand over all research and development to countries that need them.

If we want to be able to confront and end this pandemic, we will continue to need innovation from both the vaccine makers and producers who make this possible. Granting a one-time waiver will create a precedent of nullifying IP rights for a host of other medicines, which would greatly endanger future innovation and millions of potential patients.

Especially in the face of morphing COVID variants, we need all incentives on the table to protect us against the next phase of the virus. 

Rather than seeking to tear them down those who have performed the miracle of quick, cheap, and effective vaccines, we should continue supporting their innovations by defending their intellectual property rights.

Yaël Ossowski (@YaelOss) is deputy director of the Consumer Choice Center, a global consumer advocacy group.

Europe’s new Pharmaceutical Strategy needs adjustments

The existing IP framework of the EU has allowed us to get a vaccine before Christmas.

The rapid development of several highly effective vaccines against COVID19 is a great success for humanity. The United Kingdom was the world’s first country to approve a COVID vaccine, and hopefully soon, the European and US drug agencies will follow the UK’s lead.

Thanks to the very robust intellectual property (IP) framework the EU has, we were able to have the first effective COVID vaccine being developed in the EU (Germany) by a European company backed by European venture capitalists. The response of many innovative pharmaceutical and biotech companies has shown how important they are for humanity to respond to new threats such as COVID swiftly. Companies such as BioNTech, Moderna, and AstraZeneca have quickly responded early on by developing new and ground-breaking vaccines that will make 2021 most likely more enjoyable than this current year. The next pandemic might just be around the corner. Given how many humans have suffered and even lost their lives from COVID and the immense economic toll on Europeans, we need to do everything we can to foster and not stifle innovation in Europe.

Our resilience can only be increased by embracing innovation (the permission to use gene editing for covid vaccines is a good example) and allow risk-seeking investors such as venture capitalists and companies to benefit from their investments. Intellectual property rights are an essential factor. While the Commission’s new pharmaceutical strategy acknowledges IP rights as a safeguard for innovation, it also aggressively talks about centralizing pricing and reimbursement decisions away from member states and towards a unified European approach. This could be horrible news for our resilience when facing future public health crises. 

The COVID pandemic has worsened public and personal finances and hence reduces patients’ accessibility to medicines. If we want to increase access to drugs in all parts of Europe and, at the same time, maintain our high innovation incentives, we need to focus on creating more prosperity. Ultimately economic growth is the critical driver for allowing more patients to access the drugs they need. Loud rhetoric aimed at eroding patent rights is dangerous saber-rattling that might reduce our ability to innovate in the future and find cures for that 95% of known diseases we can’t cure yet.

We need to acknowledge that there are wealth disparities among EU member states, and we can’t have a one size fits all approach when it comes to access to medicines. EU-wide pricing decisions might delay introducing new medicines across the entire block and hence would be a raise to the bottom in terms of access to lifesaving drugs. We might risk getting innovative drugs at the time of their approval elsewhere in the world. Instead of loud and bold statements to negotiate drug prices down, the Commission should embrace innovation and also work on OECD-wide reciprocity of drug approvals. Why should EU citizens have to wait for the EMA to approve vaccines when they have already proved safe and available to UK residents? 

The EU Commission should maintain our excellent intellectual property standards and not intervene in the national rules for pricing and reimbursement decisions. Furthermore, it is paramount that governments refrain from picking winners in the race for new treatments and vaccines and therefore maintain technology neutrality. The German government, for instance, was quick to invest in one vaccine manufacturer early on. Still, despite a massive injection of taxpayer money, another German company won the race to be the first one with an effective vaccine. Europe is home to half of the world’s top 10 pharmaceutical companies. We should not jeopardize this position but aim for more and not less innovation in the European Union.

Originally published here.

The EU ‘should consistently charge no VAT on medicine’

In a recent move, the European Commission has suggested to EU member states to exempt Covid-19 diagnostic medical devices, as well as a potential vaccine, from value-added tax. The Consumer Choice Centre (CCC) has welcomed this move, since it incentivises a move to alleviate some of the burdens on patients and consumers as they deal with the pandemic. The CCC’s Managing Director and Health Economist Mr Fred Roeder said the EU should be more ambitious with regard to medicines.

“Member states would be right to implement VAT exemptions on medicines, not just in times of a crisis,” he commented.

“Too many patients in Europe pay too much for needed medicines because the government is taking too big of a cut. Some member states charge as much as 25 per cent for both over-the-counter (OTC) medicines, as well as prescription drugs. This burdens health insurance providers and patients alike”, said Mr Roeder.

“We should take the positive example of Malta, which is the only member state that charges no VAT for either OTC or prescription medicine, yet still manages to provide basic services to citizens. If we want to fund government services, we shouldn’t do it on the backs of patients who need medicine.

“We experience this great double standard in Europe: Politicians of major parties complain about the price of drugs on the continent, yet simultaneously charge large chunks of tax on the same drugs. It is time we end this inconsistency”, he concluded.

Originally published here.

Tarif PPN untuk Obat-Obatan di Eropa Diusulkan Maksimal 5%

Insentif pajak untuk barang-barang farmasi dinilai masih dibutuhkan mengingat kebutuhan masyarakat Eropa untuk produk kesehatan terus meningkat di tengah pandemi virus Corona atau Covid-19.

Analis Kebijakan dari The Consumer Choice Center Bill Wirtz mengatakan pembuat kebijakan di Eropa perlu merumuskan ulang kebijakan fiskal untuk produk farmasi pada masa pandemi Covid-19, terutama mengenai tarif PPN.Baca Juga: RS Ummi Bersiap Kena Sanksi Satgas Covid-19 Gegara Tak Lapor Hasil Swab Test Habib Rizieq

“Dalam komponen harga obat pendorong utama yang membuat harga menjadi lebih tinggi karena adanya pajak penjualan obat,” katanya dikutip Rabu (4/11).

Saat ini, lanjut Wirtz, sebagian besar negara Eropa masih memungut PPN untuk resep atau obat yang dijual secara bebas. Pungutan paling tinggi diterapkan Denmark dengan tarif PPN 25%. Lalu, Jerman mengenakan PPN 19% untuk resep obat dan produk obat yang dijual secara bebas.

Sementara itu, satu-satunya negara yang tidak memungut PPN atas resep obat atau obat yang dijual bebas adalah Malta. Kemudian negara seperti Luksemburg menerapkan tarif PPN rendah sebesar 3% untuk obat-obatan dan Spanyol dengan tarif PPN 4%.

Swedia dan Inggris menerapkan PPN 0% untuk resep obat yang dikeluarkan dokter. Namun, tetap memungut PPN 25% di Swedia dan PPN 20% di Inggris untuk obat yang dijual secara umum tanpa harus menyertakan resep obat dari dokter.

“Negara anggota Uni Eropa harus mencontoh Malta yang menurunkan tarif PPN sampai 0% untuk semua obat untuk mengurangi aktivitas komersial dan memastikan harga dijual dengan wajar,” ujar Wirtz.Baca Juga: Jika Vaksinasi Berjalan, Bisa Hentikan Penularan, Pulihkan Kesehatan, dan Bangkitkan Ekonomi

Wirtz berharap terdapat kesepakatan di antara negara anggota Uni Eropa untuk memastikan obat-obatan yang saat ini sangat vital dapat diakses oleh seluruh masyarakat dengan harga terjangkau. Misal, dengan mematok tarif PPN untuk obat-obatan maksimal 5%.

“Perlu adanya perjanjian mengikat untuk kebijakan tarif PPN dengan batas maksimal tarif 5% untuk menurunkan harga obat, meningkatkan aksesibilitas dan menciptakan Eropa yang lebih adil,” tutur Wirtz seperti dilansir eureporter.co

Originally published here.

Trump’s drug import plan will make us all pay

Make Canada Great Again?

Believe it or not, that’s what is at the center of President Donald Trump’s latest executive order aimed at trying to lower the cost of prescription drugs for Americans.

Trump’s plan, dubbed the “Most-Favored-Nation-Price” model, would effectively import price controls on pharmaceuticals from other nations with single-payer, government-run health systems, including Canada.

With this order, Trump will force Medicare to pay the same negotiated rates as other countries that don’t have the same level of innovation or access to medicines as the U.S

That means that while drug prices for certain seniors will be lower in the short term, it will mean higher costs in the long-term, jeopardizing future drug development, and access. And that will be bad for every American, not to mention our retirees on Medicare.

As an example, modern drug development requires not only massive investment but also time and the ability to experiment through trial and error. Only one of every 5,000-10,000 substances synthesized will make it successfully through all stages of product development to become an approved drug. That’s a big risk and one that only pays off if these drugs can be sold and used. 

Many projects fail to bring even one drug to market. Investing in life sciences requires a healthy risk appetite, and therefore an incentive scheme that rewards those able to create value is necessary. 

By the time a medical drug reaches the regular patient, an average of 12.5 years will have elapsed since the first discovery of the new active substance. The total investment needed to get to one active substance that can be accessed by a patient is around $2 billion. And that is just for medicines we already know we need.

There are over 10,000 known diseases in the world but approved treatment for merely 500 of them. It may be easy to dictate lower prices for these medicines, but that will mean that drug developers will not have the same means to invest in research for the remaining 95% of diseases we cannot yet cure.

Added to that, the U.S. can count on access to all sorts of innovative medicines because of our innovators and inventors.

By forcing lower prescription drug prices for our elderly, Trump seems eager to harm our ability to find cures for those who still hope for the development of a cure for their untreatable diseases and future access to the medicines we need.

Such a move may play well in voter rich Florida, with a large population of seniors anxious about drug prices, but it shatters the unique mix of both innovation and entrepreneurship that leads the U.S. to be the world’s top creator and supplier of badly-needed drugs. Half of the top pharmaceutical companies in the world are headquartered in our country, and for good reason.

Trump, for his part, claims that this will stop “free-riding” from other nations on the US’ relatively high drug prices. And that is indeed a concern that touches many of us. But such a rash plan will put a chokehold on innovation across the entire sector of our drug industry.

If Trump wants other countries to “pay their fair share” on drug prices, the best method is by trade agreements and negotiation, not by emulating anti-innovation policies from other nations.

To achieve cheaper drug prices, there are simpler and cheaper ways to tackle this.

For one, the president should be open to a reform of the Food and Drug Administration. Too much time is lost trying to get drugs approved across every industrialized country. If we recognized drug approvals from all other countries in the OECD, this would lower costs and accelerate the pace of bringing drugs to the US market.

We cannot risk our entire drug infrastructure for the hope of short-term lower costs. If the Trump administration wants our nation to remain a shining beacon of innovation and allows its patients to access state-of-the-art medicine, we should not import bad policies from abroad.

Yaël Ossowski is deputy director at the Consumer Choice Center.

Après cette crise, ne cédons pas au protectionnisme

Face à la crise du COVID-19, nous entendons de plus en plus d’appels en faveur d’une politique économique protectionniste. Cependant, cette politique est intellectuellement en faillite depuis des siècles et nuit au bien-être des consommateurs.

Au niveau politique, le COVID-19 nous a montré une chose : les positions politiques sont bien enlisées. Tous les bords politiques se sentent confirmés dans leurs visions du monde précédant cette crise. Les socialistes affirment que cette crise confirme que la sécurité sociale n’est pas assez développée. Pour les nationalistes, c’est la globalisation et l’ouverture des frontières qui a causé cette pandémie. Les fédéralistes européens pensent que la crise COVID-19 démontre l’importance de la  centralisation des décisions dans l’Union européenne. Enfin, les écologistes trouvent que la baisse drastique de la production permet une société plus propre et qu’il est possible de vivre avec beaucoup moins..

Comme tous ces groupes, les protectionnistes jouent leur propre jeu politique et affirment que non seulement il nous faut plus de droits de douane mais aussi qu’il faut “faire revenir” la production en Europe. 

Ils se plaignent de la dépendance européenne face à des pays comme la Chine ou l’Inde et que cette crise a montré l’intérêt de rapatrier des industries qu’ils jugent plus essentiels que d’autres. Les idées protectionnistes ont la particularité d’être représentées autant à l’extrême-gauche qu’à l’extrême-droite voir même au centre du spectre politique. Il s’avère que le protectionnisme est ancré dans notre esprit politique depuis des siècles.

Le colbertisme semble éternel

Jean-Baptiste Colbert, ministre des finances sous Louis XIV, s’était engagé dans une avalanche d’octroi de monopoles, de subventions de luxe et de privilèges de cartels, et avait mis en place un puissant système de bureaucratie centrale régenté par des fonctionnaires appelés intendants. Le rôle de ces derniers était de faire respecter le réseau de contrôles et de réglementations qu’il avait créé. 

Son système fonctionnait également à grand coups d’inspections, de recensements et de formulaires pour pouvoir identifier les citoyens qui auraient pu s’écarter des réglementations de l’État. Les Intendants ont utilisé un réseau d’espions et d’informateurs pour découvrir toutes les violations des restrictions et des réglementations du cartel. De plus, les espions se surveillaient les uns les autres. Les sanctions pour les violations allaient de la confiscation et la destruction de la production jugée “inférieure”, à de lourdes amendes, des moqueries publiques voir même l’interdiction d’exercer sa profession.

Colbert était aussi convaincu que le commerce international était un jeu à somme nulle. S’inspirant des idées du mercantilisme, il estimait que l’intervention de l’État était nécessaire pour assurer qu’il garde une plus grande partie des ressources à l’intérieur du pays. Le raisonnement est assez simple : pour accumuler de l’or, un pays doit toujours vendre plus de biens à l’étranger qu’il n’en achète. Colbert cherchait à construire une économie française qui vendait à l’étranger mais qui achetait sur le marché intérieur. L’ensemble des mesures économiques de Jean-Baptiste Colbert était connu sous le nom de “colbertisme”.

De nos jours, ce système est connu sous le nom de “protectionnisme”, et reste tout à fait courant dans la pensée politique. En Europe, nous avons abandonné cette philosophie économique (même si la Commission européenne accepte que certains Etats membres subventionnent leurs industries locales en cas de crise), mais vers l’extérieur, l’UE a maintenu trois catégories de mesures protectionnistes :

  1. Les taxes douanières par le tarif extérieur commun,
  2. Les normes de production qui imposent des coûts de convergences,
  3. Les subventions aux producteurs locaux, à travers la Politique Agricole Commune (PAC).

La question est de savoir si ces mesure protègent réellement l’économie européenne. S’il convient de retourner dans le temps pour expliquer les origines du protectionnisme, il faudrait également tirer quelques leçons du passé. Dans son Traité d’économie politique publié en 1841, l’économiste français Jean-Baptiste Say expliquait :

“L’importation des produits étrangers est favorable à la vente des produits indigènes ; car nous ne pouvons acheter les marchandises étrangères qu’avec des produits de notre industrie, de nos terres et de nos capitaux, auxquels ce commerce par conséquent procure un débouché. — C’est en argent, dira-t-on, que nous payons les marchandises étrangères. — Quand cela serait, notre sol ne produisant point d’argent, il faut acheter cet argent avec des produits de notre industrie ; ainsi donc, soit que les achats qu’on fait à l’étranger soient acquittés en marchandises ou en argent, ils procurent à l’industrie nationale des débouchés pareils.”

Considérer l’échange international, surtout dans une perspective de “déficit commercial”, comme un jeu à somme nulle, est erroné. L’idée qu’il faille faire revenir l’industrie en Europe, probablement à travers des mesures commerciales, est également fallacieuse. Il s’avère que la libéralisation des liens commerciaux est avantageux à la fois pour les pays exportateurs et ceux qui importent : les ressources entrant nous procurent la possibilité d’améliorer notre situation économique. 

L’acte commercial bénéficie aux deux acteurs et non à un seul. Croire que seul le vendeur est gagnant (car il gagne de l’argent) est une incompréhension économique grave.

Certes la crise du COVID-19 est très problématique, et nous voyons en effet une pénurie de certains matériaux médicaux. Ceci dit, produire des gants et masques en Europe ne sera pas viable économiquement et qui nous dit que les mêmes outils seront nécessaires pour la prochaine crise sanitaire ? Ceci nous montre encore une fois l’erreur fatale de penser qu’il serait possible d’organiser la société et son économie par une planification centrale gérée par l’Etat.

Tout comme le disait Jean-Baptiste Say dans ses oeuvres, pour (re)lancer l’activité économique, il faut enlever les mesures qui nous ralentissent, dont la bureaucratie excessive et l’excès de taxes. En d’autres termes, il s’agit de ne pas entraver les échanges mais plutôt permettre la multiplication des échanges.

The Consumer Choice Center is the consumer advocacy group supporting lifestyle freedom, innovation, privacy, science, and consumer choice. The main policy areas we focus on are digital, mobility, lifestyle & consumer goods, and health & science.

The CCC represents consumers in over 100 countries across the globe. We closely monitor regulatory trends in Ottawa, Washington, Brussels, Geneva and other hotspots of regulation and inform and activate consumers to fight for #ConsumerChoice. Learn more at consumerchoicecenter.org

Apakah Perlindungan Hak Kekayaan Intelektual di Bidang Medis Menguntungkan Konsumen?

Penulis Haikal Kurniawan – Usia harapan hidup dunia kian naik dari tahun ke tahun. Pada tahun 2020, diprediksi ada lebih banyak penduduk dunia yang berusia di atas 64 tahun daripada anak-anak di bawah usia 5 tahun (Roeder, 2019). Hal ini tentu merupakan suatu capaian yang mengagumkan, dan sangat perlu untuk diapresiasi.

Salah satu hal yang memainkan peran besar atas hal tersebut adalah inovasi dan perkembangan sains dan teknologi di bidang medis. Berbagai kemajuan di bidang tersebut telah membantu umat manusia untuk memiliki usia jauh lebih panjang daripada leluhur mereka yang hidup di masa lalu.

Konsumen tentu merupakan pihak yang paling diuntungkan dari perkembangan tersebut. Melalui berbagai inovasi, konsumen diberikan berbagai macam pilihan untuk memilih obat-obatan medis yang lebih beragam dan ampuh untuk mengatasi berbagai penyakit.

Lantas, apakah perlindungan Hak Kekayaan Intelektual memiliki kaitan erat perkembangan sains dan teknologi tersebut?


Hak Kekayaan Intelektual, atau HAKI, merupakan salah satu hak yang diakui secara global oleh dunia internasional. Deklarasi Universal Hak Asasi Manusia (DUHAM), Pasal 27 UDHR, menyatakan dengan eksplisit bahwa “Setiap manusia memiliki hak untuk mendapatkan perlindungan, baik secara moral, maupun kepentingan material, yang dihasilkan dari hasil karya saintifik, literatur, maupun seni yang dibuatnya.”

Perlindungan HAKI merupakan salah satu instrumen yang dibuat untuk melindungi para inovator dan seniman atas hasil jerih payah mereka. Tanpa adanya perlindungan terhadap HAKI, tentu mustahil para inovator dan seniman yang sudah bekerja keras membuat karya tertentu untuk menikmati hasil kreatifitas yang mereka buat. Orang-orang lain, yang tidak melakukan apa-apa, akan dengan mudah mengkopi dan membajak hasil karya tersebut untuk keuntungan mereka sendiri.

Hal yang sama juga berlaku untuk inovasi di bidang teknologi kedokteran, pangan, dan kesehatan. Satu hal yang memiliki peran sangat besar untuk mendorong perkembangan tersebut adalah para investor yang menginvestasikan dana mereka untuk riset dan penelitian.

Jumlah dana yang diinvestasikan tersebut tidaklah kecil. Profesor dari Fakultas Kesehatan Universitas Tufts, Joseph Dimasi, dalam jurnalnya yang berjudul “Innovation in the pharmaceutical industry: New estimates of R&D costs” memberi estimasi, agar sebuah obat bisa dipakai oleh pasien dari nol, dibutuhkan waktu riset selama 12,5 tahun dan dana sebesar 2,8 milyar Dollar Amerika, atau lebih dari 35 triliun rupiah (DiMasi, 2016).

Dana tersebut tentu bukan jumlah yang sedikit. Tanpa adanya perlindungan terhadap HAKI, tentu insentif para investor untuk menginvestasikan uang yang mereka miliki menjadi berkurang, dan bahkan hilang. Hal tersebut tentu akan sangat merugikan banyak pihak, terutama konsumen yang membutuhkan obat-obatan medis terbaru, karena riset dan penelitian menjadi terhambat.

Akan tetapi, bukankah HAKI di bidang medis akan mendorong perilaku rakus yang dilakukan oleh berbagai perusahaan farmasi demi keuntungan sebesar-besarnya?

Memang, kerakusan perusahaan farmasi demi meraih keuntungan sebesar-besarnya merupakan karikatur yang kerap digambarkan oleh para aktivis dan para politisi yang memiliki haluan kiri.

Namun, kenyataannya tidaklah demikian. Perusahaan farmasi asal Britania Raya GlaxoSmithKline (GSK) misalnya, memberlakukan kebijakan pemotongan harga obat yang mereka jual di negara-negara berkembang sebesar 25% dari dengan harga di negara-negara maju. Selain itu, perusahaan farmasi asal Swiss, Novartis, sejak tahun 2011, telah mendistribusikan lebih dari 850 juta obat anti malaria ke lebih dari 60 negara dengan jumlah penderita malaria tertinggi, tanpa mengambil profit sama sekali (Medicine for Malaria Venture, 2019).

Lantas, bila demikian, bagaimana kita dapat mengatasi biaya obat-obatan medis yang tinggi?

Cara untuk mengatasi hal tersebut bukanlah dengan menghapus HAKI, karena hal tersebut akan menghilangkan insentif yang sangat dibutuhkan untuk mendorong kemajuan di bidang medis. Solusi yang paling efisien untuk menurunkan harga obat-obatan agar terjangkau adalah menghapuskan berbagai kebijakan pemerintah yang mendorong kenaikan harga tersebut, diantaranya adalah tarif impor dan izin birokrasi yang rumit.

Tarif impor untuk produk obat-obatan medis tentu akan mendorong kenaikan harga barang tersebut di pasar, dimana yang paling dirugikan adalah masyarakat kelas menengah ke bawah. Nepal misalnya, memberlakukan kebijakan tarif impor untuk produk medis sebesar 14,7%. Tarif impor untuk obat-obatan medis di Indonesia sendiri adalah 4,3% (IDN Times, 2019).

Izin yang rumit dan berbelit juga merupakan hal yang tentu sangat menghambat perkembangan dan membuat biaya obat menjadi meningkat. Berdasarkan laporan Tempo misalnya, Menteri Kesehatan, Terawan Agus Purwanto, menyatakan bahwa izin peredaran obat baru di Indonesia bisa memakan waktu hingga berbulan-bulan, ia berjanji akan mengatasi persoalan tersebut (Tempo, 2020).

HAKI di bidang medis merupakan hal yang patut untuk dijaga demi mendorong perkembangan sains dan teknologi di bidang medis, yang tentunya akan membawa manfaat besar bagi umat manusia. Pemerintah dalam hal ini seharusnya menjadi pihak yang menjaga hak tersebut, bukan menjadi aktor yang mempersulit inovasi melalui berbagai regulasi ketat yang nantinya akan merugikan masyarakat.

Originally published here.

The Consumer Choice Center is the consumer advocacy group supporting lifestyle freedom, innovation, privacy, science, and consumer choice. The main policy areas we focus on are digital, mobility, lifestyle & consumer goods, and health & science.

The CCC represents consumers in over 100 countries across the globe. We closely monitor regulatory trends in Ottawa, Washington, Brussels, Geneva and other hotspots of regulation and inform and activate consumers to fight for #ConsumerChoice. Learn more at consumerchoicecenter.org


La trasparenza nei prezzi dei farmaci può essere positiva per i consumatori, a patto che vada di pari passo con il riconoscimento dei diritti di proprietà intellettuale e il valore dei brevetti. Un processo più chiaro e poche regole certe potrebbero velocizzare l’approvazione dei farmaci più innovativi. Che cosa possono fare l’OMS, l’Unione Europea e i singoli stati membri (inclusa l’Italia)?

Nel 2019, l’Organizzazione Mondiale della Sanità (OMS) ha approvato una risoluzione – proposta, tra gli altri, da Italia, Spagna e Lussemburgo – intesa a rendere più aperti e trasparenti i mercati farmaceutici, che sono tipicamente caratterizzati da grande opacità e prezzi alti. Uno degli obiettivi di questa risoluzione è la progressiva diffusione al pubblico di informazioni sulla copertura brevettuale e il marketing status di nuovi prodotti farmaceutici, oltre all’ottenimento di maggiore chiarezza sul drug pricing.

Sorprendentemente, il Regno Unito –  con Germania ed Ungheria –  si è dissociato dalla risoluzione, proponendo di posporre la revisione al Gennaio 2020. Non è un caso che proprio il Regno Unito abbia un sistema di diffusione di informazioni su nuovi prodotti farmaceutici opaco e poco consumer friendly. Ogni anno, infatti, il Medicines and Healthcare products Regulatory Agency (MHRA), l’autorità nazionale preposta alla regolamentazione del settore farmaceutico, approva dozzine di prodotti (inclusi farmaci generici a basso costo), ma invece di notificare e rendere pubbliche informazioni sulla loro disponibilità e copertura brevettuale le tiene in buona parte nascoste. Per questa ragione i pazienti e gli operatori sanitari hanno difficoltà ad informarsi su quali farmaci siano o saranno presto disponibili sul mercato. Questo sistema si pone in controtendenza rispetto al trend internazionale di promuovere maggiore trasparenza e chiarezza. Sarebbe auspicabile quindi seguire le migliori pratiche internazionali e rilasciare pubblicamente più informazioni sui prodotti considerati per l’approvazione e sul loro statuto brevettuale.

Ad esempio, in Canada le Patented Medicine Regulations consentono il rilascio in tempo utile di queste informazioni, rendendo quindi i pazienti più informati su scelte di assistenza sanitaria. Inoltre, la maggiore trasparenza, come osservato dall’Organizzazione Mondiale della Sanità nel Pharmaceutical System Transparency and Accountability Assessment Tool, rende le decisioni pubbliche visibili e comprensibili al pubblico, rendendo quindi i governi più responsabili. Dal canto suo, L’Unione Europea ha da tempo adottato un simile meccanismo di notifica, che però riguarda solo alcuni tipi di medicinali innovativi e i farmaci orfani.

Purtroppo, in Italia manca una totale trasparenza di questo genere.Un governo aperto ed attento ai consumatori dovrebbe fornire ai pazienti, ai dottori e ai farmacisti le informazioni necessarie su quali prodotti siano in procinto di ricevere autorizzazione all’immissione sul mercato.

In conclusione, una maggiore trasparenza – in Italia ma anche altrove –  su informazioni riguardanti lo statuto brevettuale e l’approvazione all’immissione sul mercato dei prodotti farmaceutici possa aiutare consumatori e pazienti in diversi modi: in primo luogo, rinforzando i diritti di proprietà intellettuale, verrebbe incentivato il rilascio di prodotti innovativi ed efficienti; in secondo luogo, una maggiore chiarezza potrebbe accelerare il processo di approvazione di farmaci generici a basso costo.

Una possibile soluzione per l’Italia può essere l’implementazione di un database online che non solo elenchi medicinali brevettati in tempo reale, ma che mostri anche quali autorizzazioni all’immissione sul mercato vengono richieste dai produttori di farmaci. Idealmente, questi ultimi farebbero domanda di autorizzazione all’immissione sul mercato sulla stessa piattaforma, punto di riferimento per pazienti, operatori sanitari e produttori.

Al tempo di TripAdvisor, Amazon e Ocado, è ora che le nostre pubbliche amministrazioni diffondano questo genere di informazioni. I pazienti, i dottori e, più in generale, i consumatori ne trarrebbero grandi benefici.

Originally published here.

The Consumer Choice Center is the consumer advocacy group supporting lifestyle freedom, innovation, privacy, science, and consumer choice. The main policy areas we focus on are digital, mobility, lifestyle & consumer goods, and health & science.

The CCC represents consumers in over 100 countries across the globe. We closely monitor regulatory trends in Ottawa, Washington, Brussels, Geneva and other hotspots of regulation and inform and activate consumers to fight for #ConsumerChoice. Learn more at consumerchoicecenter.org

Mehr Transparenz bei Medikamentenzulassung

Jedes Jahr lässt das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Deutschlands nationaler Agentur für Medikamente, dutzende Medikamente zu. Dabei handelt es sich sowohl um die neusten innovativen Medikamente aber auch um patentfreie Generika.

Mit dem Umzug der European Medicines Agency (EMA) von London nach Amsterdam fällt in Zukunft wahrscheinlich auch mehr Arbeit auf das BfArM, da dessen britisches Pendant MHRA der europäischen Agentur historisch stark unter die Arme griff. Doch bei Deutschlands Ansatz bei der Patentierung und Zulassung neuer Medikamente passiert nach wie vor zu viel in Hinterzimmern und ist weit von digitaler Transparenz für Patienten entfernt.

Für Patienten und Ärzte ist es in Deutschland schwer herauszufinden welche Medikamente kürzlich zugelassen wurden und was in den nächsten Monaten wahrscheinlich zugelassen wird. Dies macht Entscheidungen über einen möglichen Behandlungsplan und welche Medikamente verschrieben werden sollen deutlich schwieriger. Es ist an der Zeit dem internationalen Trend von mehr Transparenz und digitalen Informationsportalen für Patienten und Ärzten zu folgen und diese Informationen öffentlich zugänglich zu machen.

Während die EMA bereits eine solche Datenbank für innovative Medikamente und seltene Krankheiten (Orphan Drugs) betreibt, stehen Patienten in Deutschland bei den meisten Medikamenten weiterhin im Dunkeln. Ein offenes und transparentes Gesundheitswesen sollte Patienten und Ärzten diese Information zeitnah zur Verfügung stellen.

Im Jahresbericht des Bundesinstituts für Arzneimittel und Medizinprodukte finden sich ganze zwei Seiten über das betriebliche Gesundheitsmanagement, aber leider keine einzige Zahl darüber, wie viele Marktzulassungen im letzten Jahr erstellt wurden und um welche Medikamente es sich handelt.

Das Deutsche Institut für Medizinische Dokumentation und Information (DIMDI) verfügt über ein elektronisches Register dieser Informationen, lässt an die meisten Daten aber nur sogenannte Anzeigepflichtige heran. Für den öffentlichen Teil muss auch ein umständliches und kostenpflichtiges Rechercheverfahren eingeleitet werden. Dies ist weder bürgernah noch patientenfreundlich.

Kandas Patented Medicines Regulations sind ein gutes Beispiel, wie zeitnah Informationen über den Zulassungsstatus von Medikamenten an Patienten kommuniziert werden kann. Die kanadische Datenbank wird alle 24 Stunden erneuert. Ein solches offenes System erlaubt Patienten frühzeitig über mögliche Neuerungen informiert zu sein.

Singapur ist ein weiteres Land, bei dem Transparenz bei Medikamenten groß geschrieben wird. Deutschland ist aber nicht das einzige EU Mitgliedsland, das seine Datenbanken endlich ins 21ste Jahrhundert bringen muss. Länder wie Frankreich oder Italien haben auch keine wirklichen Antworten im Bereich patientenfreundliche Transparenz.

Eine einfach zu bedienende und kostenfreie Plattform, die sowohl alle zugelassenen als auch sich in Zulassung befindliche Medkimanete auflistet, wäre ein großer Gewinn für Patienten und Ärzte. Diese Plattform würde auch dabei behilflich sein oft langwierige Rechtsstreitigkeiten um Patentschutz zwischen verschiedenen Produzenten früh anzugehen. Markteintrittsverzögerungen aufgrund Patentstreitigkeiten würden so reduziert, da eventuelle Konflikte deutlich früher aufgedeckt werden würden.

In Zeiten von Amazon, TripAdvisor und Netflix ist es sehr eigenartig, dass Informationen über verfügbare Medikamente nicht einfach online einsehbar sind. Das Bundesgesundheitsministerium sollte mehr Transparenz schaffen und somit Patienten und Ärzten eine bessere Wissensgrundlage herstellen. Dies kann im Endeffekt sogar Leben retten, denn jede Verzögerung im Gesundheitswesen kann eine schlechtere Behandlung eines Patienten bedeuten. Und das kann durch eine einfache Reform und Offenlegung vorhandener Informationen verhindert werden.

Originally published here.

The Consumer Choice Center is the consumer advocacy group supporting lifestyle freedom, innovation, privacy, science, and consumer choice. The main policy areas we focus on are digital, mobility, lifestyle & consumer goods, and health & science.

The CCC represents consumers in over 100 countries across the globe. We closely monitor regulatory trends in Ottawa, Washington, Brussels, Geneva and other hotspots of regulation and inform and activate consumers to fight for #ConsumerChoice. Learn more at consumerchoicecenter.org

Una oportunidad para transparentar el mercado de medicamentos en Perú y el Reino Unido

por Julio Clavijo

Las enfermedades no esperan, pero los gobiernos parecen no entenderlo. En Perú y Reino Unido, el acceso a medicamentos y la aprobación de nuevas alternativas se mantienen como uno de los principales problemas del sector de la salud.

Cada año, en el Reino Unido, la agencia regulatoria de medicina y productos de salud (MHRA por sus siglas en ingles), aprueba docenas de medicinas para su uso a nivel nacional. Esto incluye las nuevas medicinas patentadas y las genéricas de bajo costo.

Sin embargo, luego de Brexit, la MHRA tendrá más trabajo en este proceso debido a que la agencia europea de medicamentos (EMA) dejará de hacerse responsable de algunos de los pasos de aprobación de medicamentos innovadores para Reino Unido.

De igual forma, en Perú, los obstáculos y costos relacionados a la formalidad para acceder al mercado de medicamentos es sumamente elevada, con una excesiva tramitología y un sistema desactualizado y turbio que deja a los pacientes en la oscuridad sin alternativas de manera oportuna para su salud. En la actualidad, se calcula que US$200 millones de medicamentos informales se mueven en el Perú de acuerdo con un estudio encargado por el ComexPerú.

Adicionalmente, alrededor del 55% de los medicamentos adulterados son vendidos en establecimientos farmacéuticos debido a la falta de acceso a información y trazabilidad en los procesos, de acuerdo a lo reportado por la Dirección General de Medicamentos, Insumos y Drogas (Digemid).

La falta de transparencia y acceso a la información sobre los diversos medicamentos disponibles, al igual que su origen, trazabilidad y estado de aprobación de patentes, se encuentra entre las principales causales de los problemas que vive el sector salud, tanto en Reino Unido como en Perú.

Durante el 2019, la Organización Mundial de la Salud (OMS) adoptó una resolución que insta a los gobiernos de sus países miembros a promover la transparencia en sus mercados farmacéuticos y de la salud, incluyendo la solicitud de dar acceso público a mayor información acerca de las medicinas disponibles y en desarrollo. Esta resolución, procura eliminar aquel secretismo que actualmente existe en la industria sobre su oferta disponible y las patentes o nuevos tratamientos que se encuentran en estado de aprobación para el uso general de las personas con problemas de salud.

La tendencia internacional hacia la transparencia y acceso público a la información vía la digitalización debería ser una oportunidad para resolver algunos de estos problemas. Entre estas mejores prácticas, se incluye información sobre el estatus de los medicamentos en sus distintas fases de aprobación, producción y tiempos para su disponibilidad en el mercado. En este sentido, Canadá demuestra ser un excelente ejemplo.

La regulación canadiense de medicamentos permite el oportuno acceso a la información para los usuarios y pacientes sobre sus alternativas dentro del sistema de salud para evitar problemas de acceso y adulteración de los medicamentos disponibles. La legislación vigente también permite que el Estado sea el principal responsable al liderar un proceso más transparente y funcional dentro del proceso de aprobación de medicamentos para consumo en el mercado.

Otras mejores prácticas incluyen también a Singapur, que posee un sistema abierto de información al igual que otros países desarrollados. En dicho sistema, a través de la digitalización de los procesos de aprobación de los medicamentos, el Estado revisa de manera eficiente la situación de patentes y aprobación de medicamentos previo a su comercialización.

Este tipo de iniciativas permiten que los mercados funcionen de mejor manera, evitando la adulteración de medicamentos, reduciendo los costos de comercialización y los precios de venta al público.

Un gobierno abierto y una cultura de acceso a información de manera transparente con los pacientes y usuarios del sector debería ser priorizada como política de Estado tanto en Perú como en Reino Unido. De igual forma, Italia y Francia también se encuentran entre la lista de países que carecen de una base de datos de fácil acceso sobre la oferta, origen, disponibilidad y patentes de medicamentos en sus respectivos países.

El acceso a la información y transparencia en el mercado de medicamentos aceleraría el proceso de aprobación de medicinas genéricas de bajo costo, que podrían salvar de manera inmediata una cantidad importante de vidas. Por este motivo, se vuelve indispensable que los usuarios y los pacientes tanto en Perú como en Reino Unido, soliciten la implementación de una base de datos en línea de acceso público que permita conocer en tiempo real el status y disponibilidad de los distintos medicamentos disponibles. Esto reforzaría una cultura de prevención y permitiría a los pacientes, profesionales de la salud, proveedores de la industria farmacéutica y establecimientos farmacéuticos acceder a información relevante para evitar problemas de desabastecimiento, abuso de precios o adulteración de los medicamentos utilizados.

En este sentido, se puede encontrar ejemplos como Amazon, TripAdvisor y Ocado, donde se puede acceder a información detallada y clara sobre cada producto. Algo similar se podría hacer en el sector salud, es decir, que el usuario pueda encontrar información fidedigna sobre medicamentos, su disponibilidad, origen y estado del medicamento en caso de patentes de una forma amigable y comprensible. En tal escenario, resultaría imperativo que la administración pública traiga consigo mayor transparencia e información en tiempo real a los pacientes y profesionales de la salud. Cualquier retraso en nuestros sistemas de salud se traducen en una reducción en la calidad de vida y en pleno siglo XXI conocido como la era de información nos merecemos algo acorde a los tiempos que vivimos.

Originally published here.

The Consumer Choice Center is the consumer advocacy group supporting lifestyle freedom, innovation, privacy, science, and consumer choice. The main policy areas we focus on are digital, mobility, lifestyle & consumer goods, and health & science.

The CCC represents consumers in over 100 countries across the globe. We closely monitor regulatory trends in Ottawa, Washington, Brussels, Geneva and other hotspots of regulation and inform and activate consumers to fight for #ConsumerChoice. Learn more at consumerchoicecenter.org

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